Opinion
Case No. SA CV 03-110-GLT (ANx).
April 8, 2005
I. BACKGROUND
Defendants (collectively "Medtronic") are the assignees of U.S. Patent No. 6,152,927 (the "'927 Patent"), which relates to an anterior cervical plating system. Medtronic alleges Plaintiff's C-TEK Fixed Anterior Cervical Plate ("C-Tek Fixed") infringes claims 1 and 10-14 of the '927 Patent. The parties filed cross-motions for partial summary judgment concerning infringement.
Plaintiff also moves for partial summary judgment of invalidity and unenforceability of the '927 Patent. Medtronic filed a cross-motion on invalidity, enforceability, and Plaintiff's other affirmative defenses.
II. DISCUSSION
Summary judgment is proper if "there is no genuine issue as to any material fact and the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c).
A. Infringement
1. Legal Standard
Infringement analysis involves two steps. First, the claims of the patent must be interpreted by the Court. The proper construction of the claims is a question of law for the Court.See Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996). Where the parties do not dispute relevant facts regarding the accused product but disagree over the meaning and scope of the claims, the question of infringement becomes one of claim construction and is appropriate for summary judgment. Id.
To construe a patent claim, the Court "seeks to accord a claim the meaning it would have to a person of ordinary skill in the art at the time of the invention." Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111, 1116 (Fed. Cir. 2004). The Court first considers intrinsic evidence such as the claim language, the specification of the patent, and the prosecution history. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996).
Claim language must be given its ordinary meaning as understood by persons skilled in the art. Tex. Digital Sys. v. Telegenix, Inc., 308 F.3d 1193, 1202 (Fed. Cir. 2002). Dictionaries, encyclopedias, and treatises may be used to determine ordinary meaning. Id. "Claims must be read in view of the specification, of which they are a part." Markman, 52 F.3d at 979. However, the Court may not read a limitation from the specification into a claim if the limitation is not present in the claim language.Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 904 (Fed. Cir. 2004).
While the court may also consider such extrinsic evidence as expert testimony, inventor testimony, and other reference materials, this evidence is used "for the court's understanding of the patent, not for the purpose of varying or contradicting the terms of the claims." Markman, 52 F.3d at 981.
Next, the construed claims must be compared to the accused product to determine whether each claim is found in the product.See id. at 976. A patent claim is not infringed if an element of the claim is not present in the accused device. Digital Biometrics, Inc. v. Indentix, Inc., 149 F.3d 1335, 1349 (Fed. Cir. 1998).
A party may prove infringement, even without a literal correspondence between the accused device and the claims of the patent, where the differences between the two are insubstantial.See Gen. Mills, Inc. v. Hunt-Wesson, Inc., 103 F.3d 978, 984 (Fed. Cir. 1997). Under this "doctrine of equivalents," a plaintiff must show the accused device "performs substantially the same function in substantially the same way to obtain substantially the same result" as the patented design. See Graver Tank Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950). The doctrine of equivalents must be applied to the individual elements of the claim, not the invention as a whole.Warner-Jenkinson v. Hilton Davis Chem. Co., 520 U.S. 17, 29 (1997). If the accused product does not meet one or more limitations in a claim, either literally or under the doctrine of equivalents, the claim cannot be infringed as a matter of law.See id.; Netword, LLC v. Cent. Corp., 242 F.3d 1347, 1353-54 (Fed. Cir. 2001).
2. Infringement Analysis
Medtronic alleges Plaintiff's C-Tek Fixed infringes claims 1 and 10-14 of the '927 Patent. Claim 1 is an independent claim, and the others are dependent claims.
Plaintiff argues its C-Tek Fixed does not infringe the asserted claims because it does not have four limitations of claim 1.
a. "Spherical Recess Portion"
The parties dispute the proper construction of the limitation of claim 1 stating:
[A]n elongated plate having a top surface and a bottom surface and defining a plurality of holes between said surfaces, at least one of said plurality of holes including a spherical recess portion adjacent said top surface having a first diameter and defining an opening at said bottom surface having a second diameter less than said first diameter.
(Kravetz Decl. Ex. 1 at col. 13, lns. 12-18.)
Plaintiff argues the "spherical recess portion" must (1) be adjacent to the top surface of the plate and (2) define the opening at the bottom surface of the plate. Medtronic contends the spherical recess portion must be adjacent to the top surface of the plate, but it does not need to define the opening at the bottom surface.
Reading the limitation as a whole shows Medtronic's proposed claim construction is correct. Plaintiff's proposed construction excludes a key component of the limitation: "at least one of said plurality of holes including." Reading the limitation in light of this phrase shows the subject of the disputed portion of the limitation is the noun "at least one of said plurality of holes," not the "spherical recess portion."
The subject noun is modified by the phrases "including a spherical recess portion adjacent said top surface" and "defining an opening at said bottom surface." This is made clear by the use of the present participles "including" and "defining," which mark the beginning of the modifying phrases, plus the conjunction "and" immediately preceding "defining an opening at said bottom surface."
The phrases "having a first diameter" and "having a second diameter less than said first diameter" are not preceded by conjunctions, showing they do not modify the subject noun "at least one of said plurality of holes." These phrases modify the nouns immediately preceding them: "spherical recess portion adjacent said top surface" and "opening at said bottom surface," respectively. The noun "spherical recess portion" is not modified by "defining an opening at said bottom surface."
In sum, this limitation requires at least one of the holes in the plate to (1) include a spherical recess portion adjacent to the top surface of the plate and (2) define an opening at the bottom surface of the plate with a smaller diameter than the opening at the top surface of the plate. The patent specification supports this construction. (See, e.g., Kravetz Decl. Ex. 1 at Figures 7-14, 17-19 (depicting holes including spherical recess portions at the top surface of the plate and defining cylindrical or partly cylindrical openings at the bottom surface of the plate with smaller diameters than the openings at the top surface).)
The parties dispute the ordinary meaning of the word "portion." Plaintiff argues portion means "the spherical surface does not comprise a complete sphere." (Pl.'s Mem. Opp'n at 7.) Medtronic asserts portion means the spherical recess forms only part of the hole in the plate. In the context of the Court's claim construction, the "spherical recess portion" refers to the hole in the plate. "Portion" refers to part of the hole, not part of a spherical shape. Medtronic's construction is correct.
Because the Court finds intrinsic evidence is sufficient to understand the '927 Patent and to determine the ordinary meaning of the claim limitation, it will not consider extrinsic evidence such as expert testimony and Medtronic's conduct before the European Patent Office. See Markman, 52 F.3d at 981 (extrinsic evidence is only to be used "for the court's understanding of the patent, not for the purpose of varying or contradicting the terms of the claims").
Having construed the claim limitation, the Court now compares the limitation to the C-Tek Fixed. At least one of the holes in the C-Tek Fixed plate includes a spherical recess portion adjacent to the top surface of the plate. The hole also defines an opening at the bottom surface of the plate. The diameter of the opening at the bottom surface is less than the diameter of the spherical recess portion at the top surface. The C-Tek Fixed literally infringes this limitation of claim 1.
b. "Enlarged Heads"
Claim 1 requires a bone engaging fastener with an "enlarged head." Several claims of U.S. Patent No. 6,533,786 contain a similar limitation, "enlarged heads," which the Court construed in its Order on Cross-Motions for Partial Summary Judgment re: Infringement of the '786 Patent, issued simultaneously with this Order. (See Order at part II.A.2.g.) The Court adopts the same conclusion as to the '927 Patent. "Enlarged head" means a head with a diameter larger than the diameter of the shank.
The '927 Patent limits "enlarged heads" by requiring the heads to define "a partially spherical surface complementary to said spherical recess of said at least one hole." The parties do not dispute this portion of the claim.
The Court disagrees with Plaintiff's assertion "enlarged head" in the '927 Patent means a head with a greater height than the head of a locking screw. Claim 1 does not refer to locking screws. Many limitations of the '927 Patent contain cross-references to elements of other claim limitations. This shows that, if the drafter of the '927 Patent wanted to compare the head of the bone engaging fastener to the head of the locking screw, he knew how to make such an express comparison.
The C-Tek Fixed uses bone screws as bone engaging fasteners. The heads of the bone screws are larger in diameter than the diameter of the shanks of the screws. The C-Tek Fixed literally infringes this claim limitation.
c. "Substantially Smaller"
Claim 1 requires a bone engaging fastener with an "intermediate portion" between the shank and the head:
[H]aving a third diameter that is substantially smaller than said second diameter, whereby said first head of said first bone engaging fastener can be pivoted within said recess portion of said at least one hole so that said first bone engaging fastener can assume a plurality of angles relative to said bottom surface of said plate.
The parties dispute the proper construction of the phrase "substantially smaller."
The ordinary meaning of "substantially" is "considerable in extent." York Prods. v. Cent. Tractor Farm Family Ctr., 99 F.3d 1568, 1572-73 (Fed. Cir. 1996) (internal quotation and alteration omitted) (citing American Heritage Dictionary Second College Edition 1213 (2d ed. 1982)); see also Epcon Gas Sys., Inc. v. Bauer Compressors, Inc., 279 F.3d 1022, 1030 (Fed. Cir. 2002) (construing "substantially below" to mean "to a considerable degree").
The specification does not contain a definition of "substantially," "smaller," or "substantially smaller" requiring departure from the ordinary meaning of the phrase. The parties have not pointed the Court to any representations made during prosecution that would limit the claim beyond its ordinary meaning. The Court construes "substantially smaller" to mean a considerable degree of difference between the relative diameters.
There is no basis for imputing a numerical limitation into the claim, as Plaintiff proposes. "[T]he term `substantially' is a descriptive term commonly used in patent claims to avoid a strict numerical boundary to the specified parameter." Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358, 1367 (Fed. Cir. 2001) (internal quotation omitted). See also Modine Mfg. Co. v. United States Int'l Trade Comm'n, 75 F.3d 1545, 1551 (Fed. Cir. 1996) ("Ordinarily a claim element that is claimed in general descriptive words, when a numerical range appears in the specification and in other claims, is not limited to the numbers in the specification or the other claims."); Epcon, 279 F.3d at 1030-31 (declining to attach specific values to construe the term "substantially below").
Cases defining "substantially" to include numerical limitations are distinguishable. In Exxon Research Engineering Co. v. United States, the court construed the limitation "to increase substantially" as "an increase of at least about 30% in the relative productivity" because the specification defined "substantially increased" as an increase of at least about 30%, and because the parties did not dispute that construction. 265 F.3d 1371, 1377 (Fed. Cir. 2001). Here, the specification does not define "substantially smaller," and the parties dispute the claim construction.
In Pannu v. Iolab Corp., the court construed "substantially coplanar" to cover examples the applicant submitted to the examiner during prosecution of the patent. Because the submitted drawings showed angles up to, but not exceeding, ten degrees, the court concluded "substantially coplanar" required an angle of no more than ten degrees. 155 F.3d 1344, 1347 (Fed. Cir. 1998). Here, the parties have not pointed to any representations made by Medtronic during prosecution of the '927 Patent regarding the range of relative diameters intended to be covered by the Patent.
There also is no basis for construing the claim according to the purpose of the invention. "Nonnumerically limited descriptive claim terms are construed using the same rules of construction as any other claim term." Ecolab, 264 F.3d at 1366. The claim states "a third diameter that is substantially smaller than said second diameter." (Emphasis added.) This language relates "substantially smaller" to the third diameter, not to the function of the invention. See id. at 1366-67. Defining "substantially smaller" in terms of the function would not be proper.
The claim limitation is not invalid for indefiniteness. A finding of indefiniteness requires considering "whether those skilled in the art would understand what is claimed when the claim is read in light of the specification." Morton Int'l v. Cardinal Chem. Co., 5 F.3d 1464, 1470 (Fed. Cir. 1993). Plaintiff must show indefiniteness by clear and convincing evidence. Advanced Cardiovascular Sys. v. Scimed Life Sys., 96 F. Supp. 2d 1006, 1018 (N.D. Cal. 2000).
"The mere use of a term like `substantially' to modify a term in a claim does not render a claim indefinite." Id. at 1020. To determine whether one skilled in the art would understand the claim, courts look to disclosures in the patent specification such as measurements and the purpose of the invention. See, e.g., Exxon Research Eng'g Co. v. United States, 265 F.3d 1371, 1377-81 (Fed. Cir. 2001); Advanced Cardiovascular, 96 F. Supp. 2d at 1020.
Here, the '927 Patent discloses figure 19, showing the relative diameters of the intermediate portion of the variable bone engaging fasteners and the opening on the bottom surface of the plate. Although not accompanied by dimensions, the figure enables one skilled in the art to understand that the claimed invention enables the fasteners to move when they are inserted into the holes. This understanding is strengthened by the statement in claim 1 that the head of the fastener "can be pivoted" within the recess portion of the hole "so that said first bone engaging fastener can assume a plurality of angles relative to said bottom surface of said plate." The specification and purpose of the claimed invention show the claim limitation "substantially smaller" is not invalid for indefiniteness.
Having construed the claim limitation, the Court now compares it to the C-Tek Fixed. Although the construed claim limitation does not contain a numerical limitation, it is appropriate to consider dimensions disclosed in the patent specification when determining whether the C-Tek Fixed infringes the claim. See Modine, 75 F.3d at 1554 (finding the phrase "relatively small . . . is limited by the description of the invention in the specification"); Ecolab, 264 F.3d at 1369 (holding measurements excluded from the scope of the claim during prosecution could not infringe the limitation "substantially uniform").
Here, the drawings in the '927 Patent do not contain numerical dimensions or measurements. The specification describes an embodiment of the invention shown in figures 4-5, which depict a fixed angle and variable angle screw, respectively. In this embodiment, the diameter of the intermediate portion of the variable angle screw is 2.9 mm. (Kravetz Decl. Ex. 1 at col. 8, ln. 60.) However, the specification does not give a measurement of the diameter of the opening on the bottom surface of the plate, relative to 2.9 mm.
The specification later discusses a specific embodiment of the holes in the plate, stating the diameter of the hole at the bottom surface of the plate is 4.1 mm. (Kravetz Decl. Ex. 1 at col. 9, ln. 58.) Plaintiff argues the Court should compare 4.1 mm to 2.9 mm to arrive at a 29% degree of relative difference. The Court disagrees.
The embodiment of the screws refers only to figures 4 and 5, which depict only a fixed angle screw and variable angle screw,not a plate. Sample dimensions of the screws are provided, but there are no sample dimensions of the holes in the plate. (See Kravetz Decl. Ex. 1 at col. 7, ln. 52-col. 8, ln. 64.) Similarly, the embodiment of the plate refers only to figures 6-14, which depict only a plate, not any screws. Sample dimensions of the holes in the plate are provided, but there are no sample dimensions of the screws. (See Kravetz Decl. Ex. 1 at col. 8, ln. 65-col. 10, ln. 18.)
The author of the patent took care to omit dimensions of the plate when discussing the screws, and vice versa. It would not be appropriate to combine the dimensions disclosed in these separate contexts to restrict the scope of claim 1.
This conclusion is supported by the specification's description of an embodiment of the screw and the plate used together. The specification describes the relationship between the variable screw and the hole in the plate in general descriptive terms, not mathematical terms. It states the intermediate portion of the screw "does not fit snugly" in the hole. The screw "can still be angulated relative to the plate." (Kravetz Decl. Ex. 1 at col. 11, lns. 42-46.)
The specification does disclose a different numerical limitation of the claim. The specification describes the relative diameters of the screw and the hole by disclosing the degree of angulation resulting from the different diameters. It states, "the degree of angulation is restricted by the difference in diameters." In the preferred embodiment, "the relative diameters permit angulation of up to 20° from the axis." (Kravetz Decl. Ex. 1 at col. 11, lns. 48-53.) The surgeon can place the variable angle screw "at any angle within the defined angulation limits." (Kravetz Decl. Ex. 1 at col. 11, lns. 54-56.)
Because the specification discloses the degree of angulation achieved as a result of the relative diameters between the screw and the hole, it is appropriate to consider whether the C-Tek Fixed infringes the claim limitation "substantially smaller" by examining its degree of angulation.
The preferred embodiment describes a degree of angulation "up to" 20 degrees. A device with a screw and a hole whose relative diameters allow up to 20 degrees of angulation would infringe the limitation "substantially smaller." When the screws of the C-Tek Fixed are secured in the holes in the plate, they are able to assume an angulation of 10 degrees with respect to the plate. (Kravetz Decl. Ex. 3.) The diameter of the intermediate portion of the screw, therefore, meets the claim limitation "substantially smaller." The C-Tek Fixed literally infringes the claim limitation.
d. "Fixed Orientation"
The final disputed limitation of claim 1 reads:
[S]aid second intermediate portion [of a second bone engaging fastener] having a substantially cylindrical portion with a fourth diameter that is approximately equal to said second diameter [of an opening at the bottom surface of the plate], whereby said second head of said second bone engaging fastener cannot be pivoted within said recess portion of said at least one hole so that said second bone engaging fastener can assume a fixed orientation relative to said bottom surface of said plate.
(Kravetz Decl. Ex. 1 at col. 13, lns. 44-52.)
Plaintiff argues Medtronic acted as its own lexicographer and defined "fixed orientation" in the specification as "no micro-motion or angular movement relative to the plate." (Kravetz Decl. Ex. 1 at col. 2, lns. 30-31.) Medtronic contends the phrase "approximately equal," which describes the relative diameters of the intermediate portion of the fixed angle screw and the hole in the plate, necessarily contemplates some movement, but not movement rising to the level of pivoting.
The ordinary meaning of "approximately" is "to come near; be almost the same." Webster's New World Dictionary Third College Edition 68 (1988). The ordinary meaning of "equal" is "of the same size." Id. at 458. "Fixed" is defined as "firmly placed or attached; not movable." Id. at 512.
The specification shows the diameters of the fixed angle screw and the hole in the plate are different enough so the screw can fit inside the hole, but close enough so, once inside the hole, the screw cannot move. This, coupled with the ordinary meaning of the claim language, shows the limitation "approximately equal" should be construed as "almost the same size," and "fixed orientation" should be construed as "not movable once inserted through the hole."
The C-Tek Fixed does not literally infringe this claim limitation. Once inserted through the hole in the C-Tek Fixed plate, Plaintiff's screw can rotate up to 1.6 degrees. (Pl.'s Mem. Reply at 17.) The screw, which can move, does not meet the ordinary meaning of "fixed orientation," which requires no movement.
However, the C-Tek Fixed infringes under the doctrine of equivalents. The difference between an immobile screw when inserted in the hole in the plate, and a screw that can rotate 1.6 degrees, is insubstantial.
The diameters of the fixed angle screws and the holes in the C-Tek Fixed perform substantially the same function as the patented design: limiting the amount of angulation the screws can achieve after they are inserted in the hole. (See Kravetz Decl. Ex. 12 at 141:17-22 (Mellinger deposition testimony stating the fixed angle screw reduces "how much angulation you get out of the screw").) They perform this function in substantially the same way: by having diameters that are almost the same. (Kravetz Decl. Exs. 4, 21 (showing the diameter of the hole is 0.185-inch, and the diameter of the intermediate portion of the screw is 0.180-inch).) Finally, they obtain substantially the same result as the patented design: to achieve a rigid construct. (Kravetz Decl. Ex. 17 ("The fixed cancellous screws provide a more rigid construct and a predetermined screw angulation.").)
The C-Tek Fixed infringes the claim limitation under the doctrine of equivalents. See Graver Tank, 339 U.S. at 608;General Mills, 103 F.3d at 984.
e. Claims 10-14
Claims 10-14 are dependent to claim 1. Claim 10 requires the plate define "a plurality of vertebral nodes along the length of the plate." The word "plurality" requires two or more vertebral nodes. The C-Tek Fixed does define two or more vertebral nodes along its length. This claim is literally infringed.
Claim 11 requires at least two holes corresponding to each vertebral node. The C-Tek Fixed does have at least two holes corresponding to each vertebral node. This claim is literally infringed.
Claim 12 requires the plate to have a "rounded edge extending between said top and bottom surfaces." Upon examination of a sample C-Tek Fixed, it appears the C-Tek Fixed has a substantially flat edge between the top and bottom surfaces, with a slight curve adjacent to the top and bottom surfaces.
Neither party has met its burden of showing why the edge of the C-Tek Fixed does, or does not, meet the "rounded edge" claim limitation either literally or under the doctrine of equivalents. Medtronic's opening brief states the C-Tek Fixed "is a bone fixation system consisting of an elongated plate with an identical or equivalent rounded edge." (Medtronic's Mem. at 24.) This conclusory statement does meet Medtronic's burden of showing there is no triable issue of fact as to whether the C-Tek Fixed's edge meets the claim limitation. Without such a showing, the Court cannot grant Medtronic's motion for partial summary judgment of infringement of claim 12.
Plaintiff also does not meet its burden of showing there is no triable issue of fact as to whether the C-Tek Fixed's edge doesnot meet the limitation in claim 12. Plaintiff's opening brief does not present any facts, argument, or legal authority on this point. (Pl.'s Cross-Mot. at 29.) The Court cannot grant Plaintiff's motion for partial summary judgment as to non-infringement of claim 12.
Claim 13 requires the head of a bone engaging fastener to include "a truncated top surface." The ordinary meaning of "truncated" is "cut short or appearing as if cut short."Webster's New World Dictionary Third College Edition at 1436. As with claim 12, neither party has explained why the C-Tek Fixed does, or does not, meet the "truncated" limitation of claim 13, literally or under the doctrine of equivalents. The Court cannot grant either party's motion for partial summary judgment as to claim 13.
Claim 14 states the threads of the bone engaging fasteners are "self-tapping." "Self-tapping" is not defined by a dictionary of common usage, and the parties do not define the term. Neither party explains why the C-Tek Fixed meets, or does not meet, this limitation of claim 14. The Court cannot grant either party's motion for partial summary judgment as to claim 14.
f. Conclusion
Medtronic's motion for partial summary judgment of infringement of claims 1, 10, and 11 of the '927 Patent is GRANTED. Medtronic's motion for partial summary judgment of infringement of claims 12-14 of the '927 Patent is DENIED. Plaintiff's cross-motion for partial summary judgment of no infringement of claims 1 and 10-14 of the '927 Patent is DENIED.
B. Invalidity
The parties filed cross-motions for partial summary judgment of validity of the '927 Patent based on anticipation and obviousness. A patent is presumed valid, and each claim of a patent is presumed valid independently of the validity of other claims. 35 U.S.C. § 282 (2001). "The burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity." Id. Plaintiff, as the party asserting invalidity, must overcome the presumption of validity by clear and convincing evidence. See Beckson Marine, Inc. v. NFM, Inc., 292 F.3d 718, 725 (Fed. Cir. 2002). This burden applies to a motion for summary judgment seeking invalidity.Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 716 (Fed. Cir. 1991).
1. Anticipation
Plaintiff argues two prior art references, U.S. Patent No. 5,709,686 ("'686 Patent") and International Patent Publication No. WO 94/17744 ("'744 Publication"), anticipate claims 1 and 10-14 of the '927 Patent.
Plaintiff also asserts International Patent Publication WO 96/29948 ("'948 Publication") anticipates the '927 Patent. Plaintiff's opening brief states the '948 Publication is the same as the '686 Patent. Its reply brief states the two are not the same, but Plaintiff does not identify relevant differences between the two, argues anticipation based only on the '686 Patent, and discusses the two as if they are the same. (See Pl.'s Reply/Opp'n at 24-27.) The Court treats the '686 Patent and the '948 Publication as the same for purposes of invalidity.
A patent claim is invalid as anticipated if a single prior art reference teaches all elements as recited in the claim. Elan Pharms., Inc. v. Mayo Found., 346 F.3d 1051, 1054 (Fed. Cir. 2003). The anticipating prior art must enable one skilled in the art to practice all elements in the claim without undue experimentation. Id. The invention must have been "known or used by others in this country . . . or described in a printed publication," or in public use or on sale in this country more than one year before the filing date of the patent application. 35 U.S.C. § 102 (a), (b) (2001). Whether the prior art is anticipating is a question of fact. Rockwell Int'l Corp. v. United States, 147 F.3d 1358, 1363 (Fed. Cir. 1998).
a. '686 Patent
As a threshold matter, the parties do not dispute the '686 Patent is a prior art reference capable of anticipating the '927 Patent.
Claim 1 of the '927 Patent requires at least one hole in the plate have "a spherical recess portion." The spherical recess portion has "a first diameter." The reference to a single diameter shows all axes of the spherical recess portion have the same diameter. The ordinary meaning of sphere, "any round body or figure having the surface equally distant from the center at all points," supports this conclusion. Webster's New World Dictionary Third College Edition 1290 (1988).
The '686 Patent claims "elongated holes being oblong in shape and having a major axis DL and a minor axis DQ, which DL being greater than DQ." (Litovsky Decl. Ex. Z at col. 3, lns. 7-9.) The non-spherical holes claimed by the '686 Patent, which have two diameters of different length, do not anticipate the spherical holes with one diameter claimed by the '927 Patent.
Plaintiff cites parts of the '686 Patent allegedly showing it claims a spherical recess portion. (Pl.'s Mot. at 28.) The first citation states, "[t]he special geometry of the hole 2 allows selective use of various types of bone screws 6, 7 on one and the same bone plate." (Litovsky Decl. Ex. Z at col. 2, lns. 65-67.) This does not claim a spherical recess portion. The "special geometry" of the holes is their oval shape with two diameters. (Litovsky Decl. Ex. Z at col. 2, lns. 29-34, 51-52.) Also, the difference between bone screws 6 and 7 appears to be screw 6 has a threaded intermediate portion, while screw 7 does not. The comparison between these two screws does not disclose a spherical recess portion. Finally, figures 1 and 2 show the holes have two diameters, DL and DQ. This does not anticipate the spherical recess portion limitation of claim 1.
Because claim 1 is not anticipated, dependent claims 10-14 also are not anticipated.
b. '744 Publication
Plaintiff does not present evidence showing the '744 Publication anticipates claim 1 of the '927 Patent. The '927 Patent requires a bone engaging fastener with an intermediate portion having a diameter "substantially smaller" than the diameter of the hole in the plate, allowing the fastener to pivot in the hole. Plaintiff does not identify a portion of the '744 Publication disclosing this limitation, but states "[i]t was well known . . . in order to allow a screw [to] pivot in the opening, the shank of the screw can be made thinner." (Pl.'s Mot. at 32.)
To be invalid as anticipated, each limitation of a claim must be disclosed in a single prior art reference. Elan Pharms., 346 F.3d at 1054. That it was well-known to do something does not show the prior art reference discloses the claim limitation. The '744 Publication does not disclose fasteners with diameters substantially smaller than those of the holes. (Medtronic's Opp'n/Cross-Mot. at 28-29.) Plaintiff apparently concedes this point when it states: "The '744 Publication does not expressly teach variable angle screws." The '744 Publication does not anticipate any claims of the '927 Patent.
2. Obviousness
Plaintiff argues the '686 Patent and the '744 Publication, on their own or in combination with each other, render the '927 Patent obvious.
A patent is invalid as obvious when "the differences between the subject matter sought to be patented and the prior art are such that the subject mater as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art." 35 U.S.C. § 103(a) (2001).
Obviousness is an issue of law to be determined by the Court based on a series of factual findings. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). To find a patent obvious, a Court must determine: (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness. Id. at 17-28. When an obviousness challenge is based on multiple prior art references, a claim is obvious when all elements of the invention are taught by two or more references. Rockwell Int'l Corp. v. United States, 147 F.3d 1358, 1365 (Fed. Cir. 1998). There must be a showing of some teaching, suggestion, or reason to combine the references.Gambro Lundia AB v. Baxter Healthcare Corp., 110 F.3d 1573, 1579 (Fed. Cir. 1997).
The parties do not dispute the '686 Patent and the '744 Publication are prior art. The parties also agree the level of ordinary skill in the art is an orthopaedic surgeon specializing in the field of spinal surgery or a mechanical, biomechanical, or biomedical engineer with at least two years of experience in the field of bone implants.
a. '686 Patent
As discussed above, the '686 Patent does not disclose a spherical recess portion. Plaintiff has not presented evidence showing it would be obvious to a person of ordinary skill in the art to design holes with a spherical recess portion instead of oval holes disclosed by the '686 Patent. The statement in the '686 Patent, "the bone plate of this invention are ubiquitously applicable in the most diverse cases," is not such evidence. That statement reflects the patent author's opinion of the usefulness of the patented device, but it does not show it would be obvious to change the device to include a spherical recess portion. There is no clear and convincing evidence the '686 Patent renders any claims of the '927 Patent invalid for obviousness.
b. '744 Publication
The '744 Publication does not teach variable angle screws, as required by the '927 Patent. (See Pl.'s Mot. at 36.) Plaintiff asserts, and its expert opines, it would be obvious to one of ordinary skill in the art to use smaller screws with the plate, allowing them to assume variable angles.
Medtronic presents two arguments to the contrary. First, the evidence shows the information contained in the '744 Publication was submitted to the Patent and Trademark Office ("PTO") in other documents. U.S. Patent No. 5,364,399 ("'399 Patent"), the patent corresponding to the '744 Publication, was disclosed to the PTO. (Litovsky Decl. Ex. A at 4.) Despite the '399 Patent, the PTO issued the '927 Patent. Patent examiners are presumed to do their job correctly and to know what claims they are allowing. Al-Site Corp. v. VSI Int'l, Inc., 174 F.3d 1308, 1323 (Fed. Cir. 1999). The challenging party's burden is especially difficult when the prior art was before the PTO during prosecution of the patent.Id.
Second, Medtronic's expert opines it would not have been obvious to use smaller screws to allow them to assume variable angles. The '686 Patent tends to corroborate this opinion. The '686 Patent achieves variable angle screws by using oval-shaped holes, not smaller screws.
Plaintiff's expert opinion is not clear and convincing evidence sufficient to overcome the presumption of validity. The '744 Publication does not render any claims of the '927 Patent invalid for obviousness.
C. '686 Patent and '744 Publication Combined
Plaintiffs offers no evidence showing a motivation to combine the '686 Patent and the '744 Publication, which is required to find obviousness based on multiple prior art references. Gambro Lundia AB, 110 F.3d at 1579. It appears Plaintiff no longer asserts obviousness based on a combination of the two references. (See Pl.'s Reply/Opp'n at 29.) Because there is no clear and convincing evidence of a motivation to combine, the '927 Patent is not invalid as obvious based on a combination of the '686 Patent and the '744 Publication.
3. Conclusion
Medtronic presents evidence raising genuine issues of material fact as to anticipation and obviousness of the '927 Patent. Plaintiff does not meet its burden of showing clear and convincing evidence of no anticipation and no obviousness sufficient to defeat the presumption of validity. Plaintiff's motion is DENIED as to invalidity, and Medtronic's motion is GRANTED as to validity.
C. Unenforceability
Plaintiff argues the '927 Patent is unenforceable due to Medtronic's inequitable conduct before the PTO when prosecuting the patent. Patent applicants must prosecute applications with candor, good faith, and honesty. Molins PLC v. Textron, 48 F.3d 1172, 1178 (Fed. Cir. 1995). "A breach of this duty constitutes inequitable conduct." Id. Inequitable conduct can render a patent unenforceable. See Ulead Sys., Inc. v. Lex Computer Mgmt. Corp., 351 F.3d 1139, 1144 (Fed. Cir. 2003).
Plaintiff contends Medtronic committed inequitable conduct by: (1) failing to submit a translation of International Patent Publication WO 96/29948 ("'948 Publication"), (2) failing to correct a misleading statement about the significance of the '948 Publication, (3) failing to submit the '686 Patent and inform the PTO that foreign patent offices had cited it in counterpart applications, (4) failing to submit the '744 Publication, and (5) submitting false affidavits stating Drs. Sonntag, Papadopoulos, and Haid were inventors.
To deem a patent unenforceable, the party asserting inequitable conduct must show: (1) an omission or false statement made to the PTO; (2) materiality of the omission or statement; and (3) intent to deceive the PTO. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1362 (Fed. Cir. 2003). Materiality and intent must be established by clear and convincing evidence. Ulead, 351 F.3d at 1144. The court then weighs materiality and intent "to determine if equity warrants a finding of inequitable conduct." Id.
1. '948 Publication Translation
The parties do not dispute an English translation of the '948 Publication, which was submitted to the PTO in German, was material to prosecution of the '927 Patent. The parties disagree whether Medtronic submitted a translation to the PTO. There is a genuine issue of material fact as to whether Medtronic submitted the translation.
The parties also dispute whether, if Medtronic did submit the translation, it did so in a timely manner. Plaintiff points out the patent examiner allowed claim 1 of the '927 Patent before Medtronic alleges it submitted the translation. Assuming Medtronic did submit the translation for purposes of this argument, it did so within three months of learning of its significance from a foreign patent office. This meets the timeliness requirement of 37 C.F.R. § 197(e)(1).
Plaintiff's objection to the portion of paragraph 3(1) of Jason R. Buratti's Declaration reading: "provided to the PTO by the Woodard Emhart law firm that prosecuted the '927 application" is sustained. The Court does not consider the content of Exhibit 1 to the Buratti Declaration and does not rule on Plaintiff's objection to Exhibit 1.
Even assuming Medtronic did not submit the translation, Plaintiff has not presented clear and convincing evidence showing Medtronic intended to deceive the PTO. "Intent need not be proven by direct evidence; it is most often proven by a showing of acts, the natural consequences of which are presumably intended by the actor. Generally, intent must be inferred from the facts and circumstances surrounding the applicant's conduct." Molins PLC, 48 F.3d at 1180-81 (internal citations omitted). "The more material the omission or the misrepresentation, the lower the level of intent required to establish inequitable conduct, and vice versa." Critikon, Inc. v. Becton Dickinson Vascular Access, 120 F.3d 1253, 1256 (Fed. Cir. 1997).
Here, Plaintiff claims the applicant intended to deceive the PTO because, on the March 2, 1999 Information Disclosure Statement ("IDS") to the PTO, which included to the '948 Publication, the applicant marked the box "Yes" in the "translation" column corresponding to the '948 Publication. Plaintiff contends this shows the applicant's intent to deceive the PTO into thinking the examiner had reviewed the translation, when in fact he had not.
The Court disagrees. The IDS does not state the "translation" box is only to be marked by the patent examiners. It appears applicants are supposed to check the box when they include a translation with a reference they are sending to the examiner. (See also Litovsky Decl. Ex. M at 208.) It does not appear the box is supposed to be checked by the examiner to show he has actually read the translation. The examiner's initials next to each reference appear to convey this information.
Here, since the box was checked before being sent to the examiner, it is not clear how the examiner would have been fooled into thinking he had reviewed the translation, or why he would have left the mark alone if he did not review or receive the translation. It appears the applicant checked the box to inform the examiner a translation was included in the submitted materials, not to attempt to convey to the PTO the patent examiner had actually reviewed the translation. Regardless of whether the translation was actually submitted, it seems the applicant subjectively believed the translation was submitted with the IDS.
This conclusion is further supported by the IDS cover letter, which states the '948 Publication "is resubmitted herein along with its translation for consideration by the examiner." (Buratti Decl. Ex. 2 at 19 (emphasis added).) This brought the examiner's attention to the translation. It is apparent the applicant sought to draw attention to the translation, not conceal it. Even if the translation was never submitted, referring to it twice would bring the examiner's attention to the fact it was missing, not lead the examiner or the PTO to believe it was submitted and reviewed. There is no clear and convincing evidence of an intent to deceive the PTO.
2. Statement of the '948 Publication's Significance
The patent applicant initially informed the PTO the '948 Publication, "taken alone or in combination with other art, may relate to the subject matter of the claimed invention, but fails to teach, disclose, or suggest the same." (Litovsky Decl. Ex. F at 3.) Later, the European and Australian Patent Offices, considering counterpart patent applications to the '927 Patent, informed the patent applicant the '948 Publication and the '686 Patent presented major obstacles to receiving the foreign patents. Plaintiff argues after this notice, Medtronic did not update its statement to the PTO of the significance of the '948 Publication. This misstatement and omission, Plaintiff contends, constitutes inequitable conduct.
The Court disagrees. First, it is not clear the initial statement is false. Foreign countries have different patentability standards than the United States. A rejection by another country does not necessarily mean the reference "teaches, discloses, or suggests" the subject matter of the invention as defined by U.S. standards.
Second, even if this statement can be construed as misleading, there is no clear and convincing evidence of intent to deceive the PTO. After hearing from the foreign patent offices, Medtronic informed the PTO those offices had cited the '948 Publication. (Buratti Decl. Ex. 2 at 1.) This shows Medtronic did not intend to conceal the '948 Publication from the PTO. Maintaining its position as to the significance of the '948 Publication according to U.S. patentability standards, despite actions by foreign patent offices, is not clear and convincing evidence of intent to deceive the PTO.
3. '686 Patent
It is undisputed Medtronic did not disclose the '686 Patent to the PTO. Plaintiff asserts this omission was inequitable conduct because it was a material, intentional omission and because it violated the Manual of Patent Examining Procedures ("MPEP").
Information is material when it is not cumulative to information already before the PTO, and when it establishes a prima facie case of unpatentability or refutes the applicant's position. 37 C.F.R. § 1.56(b). Medtronic argues the '686 Patent is not material because it was cumulative to the '948 Publication before the PTO.
The '686 Patent is material with respect to the German version of the '948 Patent because there is a substantial likelihood a reasonable patent examiner would have considered it important to have the '686 Patent, which is in English, in addition to the German publication. See Hoffmann-La Roche, Inc. v. Promega Corp., 323 F.3d 1354, 1367 (Fed. Cir. 2003). Whether the '686 Patent is material with respect to the translation of the '948 Publication depends whether the translation was submitted to the PTO. If the translation was submitted, the '686 Patent is cumulative. As discussed above, the parties have raised genuine issues of material fact on this point.
Even if the '686 Patent is material, however, there is no clear and convincing evidence of intent to deceive the PTO. The patent applicant's multiple references to the translation of the '948 Publication show he intended to disclose that translation to the PTO and apparently believed he had done so. The evidence shows the patent applicant likely believed the '686 Patent, which is in the same patent family as the '948 Publication, was cumulative to the '948 Publication. Plaintiff has not identified evidence showing the applicant knew the '686 Patent was material and intentionally withheld it to deceive the PTO.
Patent applicants have a duty to disclose "prior art cited in search reports of a foreign patent office in a counterpart application." 37 C.F.R. § 1.56(a)(1). The MPEP effective in 1998 states U.S. patents listed in the same patent family as a patent cited by a foreign patent office are considered "cited" for purposes of 37 C.F.R. § 1.97(e)(1). (Pl.'s Extrajurisdictional Authority Ex. A at 10.) By analogy, patents listed in the same patent family would likely be considered "cited" for purposes of section 1.56(a)(1) as well. The '686 Patent was listed in the patent family of the '948 Publication in the December 23, 1998 International Search Report ("ISR"). (Litovsky Decl. Ex. G at 187.) The '686 Patent was, therefore, "cited."
Plaintiff also contends Medtronic failed to disclose the foreign patent office's citation of the '948 Publication. Medtronic did make this disclosure. (Buratti Decl. Ex. 2 at 18 ("The items of information included herein [including the '948 Publication] were cited in a communication from a PCT office in a counterpart application to the present application less than three months prior to the filing of this information disclosure statement.").)
Despite Medtronic's failure to cite the '686 Patent, Plaintiff has not provided authority showing a violation of the MPEP can constitute inequitable conduct. It is not readily apparent why, even if the MPEP states applicants should disclose U.S. patents in the same patent family, those patents would not be cumulative to other patents disclosed to the PTO for purposes of determining materiality under an inequitable conduct analysis. Even if an MPEP violation can constitute inequitable conduct, Plaintiff does not present clear and convincing evidence showing Medtronic intended to violate the MPEP. The violation does not rise to the level of inequitable conduct and does not justify finding the '927 Patent unenforceable.
4. '744 Publication
Plaintiff apparently does not dispute the '399 Patent is the corresponding patent to the '744 Publication. The '399 Patent was before the PTO. The '744 Publication was cumulative to information before the PTO and is not material. Failing to disclose the '744 Publication to the PTO was not inequitable conduct.
5. Inventorship Affidavits
Plaintiff argues Medtronic filed false affidavits with the PTO stating Drs. Sonntag, Papadopoulos, and Haid were inventors of the patent, when in fact they were not. Medtronic asserts the affidavits are true, and it had no intent to deceive the PTO. The parties do not dispute the affidavits are material.
Deceptive affidavits with half-truths can be false statements for inequitable conduct purposes. Paragon Podiatry Lab. v. KLM Lab., 984 F.2d 1182, 1192 (Fed. Cir. 1993). "[T]he inference of an intent to deceive the PTO is strongly supported by the submission of . . . deceptive affidavits. . . . The inference arises not simply from the materiality of the affidavits, but from the affirmative acts of submitting them, their misleading character, and the inability of the examiner to investigate the facts." Id. at 1191.
Plaintiff has not presented a genuine issue of material fact showing the affidavits are false. The undisputed facts show the doctors were joint inventors of the '927 Patent. Because they were inventors, their affidavits are true.
Inventorship is a question of law. Bd. of Educ. ex rel. Bd. of Trs. v. Am. Bioscience, Inc., 333 F.3d 1330, 1337 (Fed. Cir. 2003). A joint inventor is a person who makes a significant contribution to the conception or reduction to practice of the invention. Id.;Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed. Cir. 1998). It is not enough if the person merely assists the actual inventor by explaining well-known principles or the state of the art, without ever having a firm and definite idea of the invention as a whole.Am. Bioscience, 333 F.3d at 1338 (citing Ethicon, Inc. v. United States Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998)).
Here, the facts show the doctors were joint inventors. All three doctors attended an initial meeting in Memphis and many other meetings over the next couple years, during which they worked with each other and with engineers to develop and design the invention. This is corroborated by deposition testimony, meeting agendas, and handwritten notes. The evidence does not show the doctors were merely explaining known principles or the state of the art to the true inventors.
Plaintiff's objections to Buratti Declaration Exhibits 8-12 are overruled.
Plaintiff asserts the doctors cannot identify specific contributions they made to the design of the invention or any technical details of the invention. Plaintiff has not cited authority showing such specificity is required. The evidence shows the doctors engaged in a collaborative process over several years, during which each doctor contributed to the conception and reduction to practice of the invention. That the doctors cannot now remember specific contributions does not show they were not inventors.
[T]he named inventors testified regarding the conception of the invention to the best of their recollection. Although the inventors were incapable of recalling each individual's specific contribution, they all generally recalled collaborating together in a series of meetings to produce the patented invention . . . Significantly, none of the inventors testified that any named inventor was not involved in that collaborative effort.Canon Computer Sys. v. Nu-Kote Int'l, 134 F.3d 1085, 1088 (Fed. Cir. 1998).
That the doctors had not seen the '927 Patent itself before this litigation, did not participate in its prosecution, and did not understand the meaning of some claims does not negate inventorship. Plaintiff cites no authority showing inventors must understand technical claim language, prosecute the patent, or have a copy of the patent after it is complete to be considered inventors.
"[T]he inventors as named in an issued patent are presumed to be correct." Id. (internal quotation omitted). Plaintiff does not present evidence sufficient to rebut this presumption. See id. Plaintiff also has not shown, by clear and convincing evidence, Medtronic intended to deceive the PTO as to the doctors' inventorship. The evidence shows the doctors subjectively believed they were inventors. The doctors' affidavits are not grounds for a finding of inequitable conduct.
D. Plaintiff's Other Affirmative Defenses
Medtronic moves for partial summary judgment on Plaintiff's remaining affirmative defenses of estoppel, laches, unclean hands, and failure to state a claim. Medtronic points out Plaintiff did not identify any facts supporting its affirmative defenses in its interrogatory responses. This meets Medtronic's burden of showing an absence of evidence to support these affirmative defenses.Celotex Corp. v. Catrett, 477 U.S. 317, 325 (1986).
The burden then shifts to Plaintiff to "designate specific facts showing that there is a genuine issue for trial." Id. at 324 (citation omitted). Plaintiff has not identified any facts supporting its affirmative defenses. In fact, Plaintiff does not respond to this portion of Medtronic's motion. There do not appear to be material issues of triable fact as to these affirmative defenses. Summary judgment is appropriate.
III. DISPOSITION
Medtronic's motion for partial summary judgment of infringement of claims 1, 10, and 11 of the '927 Patent is GRANTED. Medtronic's motion for partial summary judgment of infringement of claims 12-14 of the '927 Patent is DENIED. Plaintiff's cross-motion for partial summary judgment of no infringement of claims 1 and 10-14 of the '927 Patent is DENIED.
Plaintiff's motion for partial summary judgment of invalidity and unenforceability of the '927 Patent is DENIED. Medtronic's motion for partial summary judgment of validity and enforceability, and on Plaintiff's other affirmative defenses, is GRANTED.