# United States **Court of Appeals**  **for the Federal Circuit**

______________________ SYNTHES USA, LLC ( formerly known as Synthes (U.S.A.) ) AND DEPUY SYNTHES PRODUC TS, LLC, Plaintiffs

- Appellants,

v.

SPINAL KINETICS, INC ., Defendant

- Cross Appellant.

______________________

2013

- 1047,

- 1059

______________________ Appeals from the United States District Court for the Northern District of California in No. 09

- CV

- 1201, Senior J udge Ronald M. Whyte.

______________________

Decided: October 29, 2013

______________________

J EFFREY M. O LSON , Sidley Austin, LLP, of Los Ang eles, California, argued for plaintiff s- appellant s . With him on the brief w as M ATTHEW S. J ORGENSON

. Of counse l on the brief was C ONSTANTINE L. T RELA , J R ., of Chicago, Illinois.

R OBERT W. D ICKERSON , Dickstein Shapiro, LLP, of I rvine, California, argued for defendant

- cross appellant. With him on the brief were A LLAN W. J ANSEN , C HARLES A. K ERTELL , E HAB M. S AMUEL and M ARK A. S TIRRAT

. OfSYNTHES USA , LLC v. SPINAL KINETICS , INC

. 2

counsel was J AMES W. G ERIAK , Sheppard Mullin Richter & Hampton, LLP, of Costa Mesa, California.

______________________
Before P ROST , O’M ALLEY , and T ARANTO , Circuit Judges.
Opinion for the court filed by Circuit Judge O’M ALLEY

.

Dissenting opinion filed by Circuit Judge T ARANTO

. O’M ALLEY , Circuit Judge.
Synthes USA, LLC and DePuy Synthes Products, LLC (collectively, “Synthes”) 1 appeal from a jury verdict fin ding that Spinal Kinetics, Inc. (“SK”) did not infringe

c laims 29

– 31 (“asserted claims”) of U.S. Patent No. 7,429,270 (“the ’270 patent”) and that the claims were invalid for lack of written description. SK cross

- appeals contending that the district court erred in denying SK’s motion for fees under 35 U.S.C. § 285

. Both appeal s are timely, and we have jurisdiction u nder 28 U.S.C. § 1295(a)(1). For the reasons below, we affirm the jury verdict of invalidity for lack of written description and affirm the district court’s denial of SK’s request for atto rney s’ fees.

1 During the pendency of the district court procee dings through final judgment and at the time the present appeal was docketed, the patent

- in

- suit was assigned to Synthes. After briefing on this appeal was complete d but before oral argument, the patent

- in

- suit was assigned to DePuy Synthes Products, LLC ( “DePuy”). To reflect that change, DePuy was added as an appellant in this case and the caption was modified to reflect that addition. See Synthes USA, LLC v. Spinal Kinetics , 13

- 1047, ECF No. 48 (Fed. Cir. July 3, 2013).SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 3

I. B AC KGROUND
A. The ’270 Patent and Accused Devices
Synthes filed this action alleging that SK’s M6

- C and M6

- L intervertebral implants infringed c laims 29

– 31 of the ’270 patent. See Synthes (USA) v. Spinal Kinetics, Inc. , 5:09 -cv- 1201

- RMW, ECF No. 1 (N.D. Cal. Nov. 12, 2008)

. The ’270 patent originated from a German la nguage PCT application filed on April 14, 2003. The a sserted claims were added by a mendment on February 19, 2008. The ’270 patent is directed to an “Intervertebral Implant,” which is a prosthet ic device designed to replace a diseased or degenerated disc located between adjacent vertebra e of t he human spine:

A healthy disc (depicted below) has a fibrous, outer band called the annulus fibrosus, which surrounds a central, gel- like substance called the nucleus pulposus:SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 4

A natural disc provides shock

- absorbing functions and helps maintain proper spacing, stability, and motion within the spine. Artificial discs attempt to replace some or all of these functions. Claim 29, th e independent claim from which c laims 30 and 31 depend , provides : 29. An intervertebral implant for implantation b etween an upper and lower vertebrae, the implant having a central axis, the implant comprising: a first substantially rigid bone contacting p late having an external surface extending generally transversely to the central axis for contacting at least a portion of the upper vertebra;
a second substantially rigid bone contacting plate having an external surface extending generally transversely to the central axis for contacting at least a portion of the lower vertebra;
a third plate operatively coupled to the first bone contacting plate, the third plate including a pl urality of openings;
a fourth plate operatively coupled to the second bone cont acting plate, the fourth plate including a plurality of openings;SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 5

a central part substantially located between the third and fourth plates, the central part including a flexible core and a fiber system, wherein the core is substantially cylindrical and includes a top surface and a bottom surface, the top surface of the core being in contact with the third plate and the bottom surface of the core being in contact with the fourth plate, and wherein the fiber sy stem at least partially surrounds the core, and is at least partially received within the plurality of openings formed in the third and fourth plates so that the fiber system is joined to the third and fourth plates; and
an elastic sheathing body at least partially su rrounding the fiber system and the core, and co nnected to the third and fourth plates.
’270 patent

, col. 8, ll. 19

– 48. Claim 30 requires that the first and second bone co ntactin g plates recited in c laim 29 be made from titanium or titanium alloy. Id. at col. 8, ll. 49

– 51. Claim 31 r equi r es the fiber system recited in c laim 29 to be co nstructed of an “ ultra high molecular weight polyethylene material. ” Id. at col. 8, ll. 52

– 54. According to Synthes,

c laim s 30 and 31 stand or fall with c laim 29. The main features of c laim 29 are depicted in Figures 3 and 4 of the ’270 patent:SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 7

Except for the shape of the cores, the M6

- C and M6

- L are identical fo r purposes of this litigation.
B. Proceedings Below
During the course of the litigation, the district cour t construed a number of terms contained in c laim 29 of the ’270 pa tent. Of particular relevance to the current appeal is the court’s construction of the phrase “the third plate including a plurality of openings .” 2 Syn the s , ECF No. 84 (N.D. Cal. June 23, 2010). SK argued that “plura lity of openings” should be limited to grooves on the ci rcumference of the claimed cover plates. Id. SK’s argument was predicated on its contention that the written description of the ’270 patent does not describe a structure with holes or slots in the cover plates, but only describes grooves on the circumference of the cover plate that radially penetrate into the lateral surface of the plate. Id. Those grooves are depicted as element 18 in Figure 2 of the ’270 patent:

2 Claim 29 recites that both the third and fourth plates include a “plurality of openings.” See ’270 patent

, col. 8, ll. 19

– 48. The court’s claim construction of the phrase applied to both limitations, but for ease of reference we only recite the third pla te.SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 8

See ’270 patent

, col. 5, ll. 11

– 13. Synthes, on the other hand, contended that the claim was not so limited, and urged the court for a broader construction : “a third plate including two or more ope nings .” Id. While the district court did not adopt Synthes’ construction wholesale, it did side with Synthes regarding the breadth of the phrase and construed it as “the third plate including two or more openings to allow the fiber system to be joined or anchored to that plate.” Id. The court concluded that c laim 29 requires openings in the cover plates, or third and fourth plates, which make it possible for the claimed fiber system to be joined or a nchored to the plates. Id. The importance of the “plurality of openings” limit ation to Synthes’ infringement case is evident when viewed in light of the accused devices. SK devices do not employSYNTHES USA , LLC v. SPINAL KINETICS , INC

. 9

peripheral grooves, but instead use slots, or openings, on the cover plates. The M6 lumbar device uses trapezoidal slots, while the cervical device uses elongated circle slots:

Joint Appendix (“J.A.”) at 24515; 24172. According to SK, Synthes amended the application that led to the ’270 patent during prosecution to add claims 29

– 31 only after the M6 devices were on the market and Synthes was advised that SK’s M6 devices were a significant improv ement in the technology. See J.A. at 20676; 25947. After the court construed the disputed terms of the patent, it en tertained motions for summary judgment. The district court granted Synthes’ motions dismissing SK’s enablement, indefiniteness, and utility defenses , but denied Synthes’ motion to dismiss SK’s written descri ption and best mode defenses

. See Synthes , ECF No. 298 (N.D. Cal. Aug

. 19, 2011). T he parties p roceeded to trial on the remaining issues. After hearing all of the evidence, followed by four days of deliberation, the jury concluded that SK’s M6 devices did not infringe the asserted claims of the ’270 patent and that SK proved by clear and co nvincing evidence that c laim 29

, and conse quently c laims 30 and 31, were invalid for a lack of written description support. See Synthes , ECF No. 497 (N.D. Cal. Dec. 13, 2011).SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 10

Synthes then moved the district court for judgment as a matter of law (“JMOL”) or new trial as to literal i nfringement and invalidity, among other things. Id. SK moved for attorneys’ fees, among other things. Id. The district court denied Synthes’ motion for JMOL or new trial as to lite ral infringement , but granted

- in

- part Sy nthes’ motion regarding invalidity for lack of written description

. See Synthes , ECF No. 577 (N.D. Cal. Sept. 27, 2012). According to th e district court, the jury found the ’270 patent invalid for lack of written description on four claim limitation s : (1) “plate in cluding a plurality of openings ”; (2) “wherein the core is substantially cylindr ical ” ; (3) “flexible core ”; and (4) “substantially rigid bone contacting plate. ” Id. Synthes argued that SK failed to produce substantial evi dence as to all four

. Id. The district court agreed with Synthes that SK failed to carry its burden on “substantially cylindrical core” and “ su bstantially rigid bone contacting plate.” Id. The court affirmed the jury verdict, however, on “plate including a plurality of openings” and “wherein the core is substa ntially cylindrical.” Id. The court also denied SK’s motion for attorneys’ fees under 35 U.S.C. § 285. Id. Synthes then filed this appeal and SK cross

- appealed.

II. D ISCUSSION The district court found substantial evidence suppor ted the jury verdict that the term “plate including a plura lity of openings” lacked written description support, rendering the asserted claims invalid. The d istrict court also concluded that SK failed to demonstrate that it was entitled to attorneys’ fees. We agree with the district court on both counts. Consequently, we find the remai ning issues on appeal moot.
A. Legal Standard
We review the denial of JMOL or request for a new trial after a jury verdict under the same standard of review as the trial court. Lucent Techs., Inc. v. Gateway,SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 11

Inc. , 580 F.3d 1301, 1309 (Fed. Cir. 2009) (citing Wechsler v. Macke Int’l Trade, Inc. , 486 F.3d 1286, 1290 (Fed. Ci r. 2007)). The grant or denial of JMOL is a procedural i ssue not unique to patent law; therefore , we apply the law of the relevant regional circuit. Id. (citing Summit Tech., Inc. v. Nidek Co. , 363 F.3d 1219, 1223 (Fed. Cir. 2004)). The Ni nth Circuit reviews denial of JMOL de novo. First Nat’l Mortg. Co. v. Fed. Realty Inv. Trust , 631 F.3d 1058, 1067 (9th Cir. 2011) (citing Lakeside

- Scott v. Multnomah Cnty. , 556 F.3d 797, 802 ( 9th Cir. 2009)). We must draw all reasonable inferences in fav or of the jury’s verdict

, and
t he evidence is viewed in the light most f avor able to the

non

- moving party

. Id. T he jury’s “verdict will be upheld if it is supported by substantial evidence, ‘even if it is also possible to draw a contrary conclusion.’” Id

. at 1067

– 68 ( quoting Pavao v. Pagay , 307 F.3d 915, 918 (9th Cir. 2002) ).
1. Written Description The district court, at Synthes’ urging, broadly co nstrued the phrase “third plate including a plurality of openings ,” which appears in claim 29

. The relevant claims, moreover, include broad language added during prosecution. Synthes amended the application that became the ’270 patent to add the concept of “openings” in claim 29 almost five years after the application was originally filed, and after SK’s M6 dev ices were already on the market. See J.A. at 20676; 25157

– 25179. The orig inal disclosure claimed and disclosed a plurality of grooves and a plurality of channels, but did not describe “ope nings” generally. See id. While broadening claims during

prosecu tion to capture a competitor’s products is not improper, the written description must support the broadened claims. See Liebel

- Flarsheim Co. v. Medrad, Inc. , 358 F.3d 898, 909 n.2 (Fed. Cir. 2004) (“[I]t is not improper for an applicant to broaden his claims during prosecution in order to encompass a competitor’s pro ducts, as long as the disclosure supports the broadenedSYNTHES USA , LLC v. SPINAL KINETICS , INC

. 12

claims.”) (citing Kingsdown Med. Consultants, Ltd. v. Hollister, Inc. , 863 F.2d 867, 874 (Fed. Cir. 1988)). After hearing the testimony of SK’s expert

, Dr. Lee

, and its research and development manager

, Mr. Koske

, indica ting that the as

- filed disclosure did not demonstrate po ssession of an intervertebral implant that employed any sort of openings anywhere on the cover plates , the jury determined that the ’270 patent was invalid under § 112, paragraph 1

. As the district court did before us, we find tha t substantial evidence supports that conclusion

. Section 112, paragraph one of Title 35 requires a p atentee to provide a written descript ion that allows a person of skill in the art to recognize that the patentee invented what is claimed. 3 See Ariad Pharms., Inc. v. Eli Lilly & Co. , 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citing Vas

- Cath Inc. v. Mahurkar , 935 F.2d 1555, 1562

– 63 (Fe d. Cir. 1991))

. “[T]he test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor ha[d] possession of the claimed subject matter as of the filing date.” Id. Determinatio n of whether a patent satisfies the written description requirement is a question of fact. Id. (citing Capon v. Eshar , 418 F.3d 1349, 1357

– 58 (Fed. Cir. 2005)). The “level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Id. Synthes contends that the jury’s verdict of invalidity for a lack of adequate written description was not su pported by substantial evidence. Synthes asserts that the ’270 patent’s written description does not limit the

3 Congress recently changed the language and structure of 35 U.S.C. § 112. See Leahy

- Smith America Invents Act, P UB

. L. N O

. 112

- 29 . Those amendments made no changes of relevance to this appeal.SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 13

claimed “plurality of openings” to peripheral grooves. Synthes next argues that the testimony and evidence presented by SK via its expert and fact witnesses regar ding the “plura lity of openings” limitation did not support the jury’s verdict. Synthes also disputes the district court’ s post

- trial conclusion that SK produced evidence demonstrating that the field of intervertebral implants was sufficiently unpredictable such that a disclosure of one species of openings would not be eno ugh to claim the entire genus. We disagree on all counts.

T he ’270 patent ’s written description , filed on April 14, 2003, discloses that the fiber system may be anchored by various means. See ’270 patent, c ol. 2, ll. 4

– 6. The written description then discloses a series of examples of how the fiber system may be anchored on the cover plate s, i.e., third and fourth plates. All of these examples employ “grooves,” not slots or openings on the plates. See
e.g. , ’ 270 patent, c ol. 3, ll. 22

– 26 (describing anchoring the fiber system “through grooves and over the external surfaces of the cover plates from one groove to another

one ”); id. , col. 3, ll. 32

– 34 (anchoring the fiber system by using “a wedge

- shap ed construction of the grooves”); id.

, c ol. 3, ll. 36

– 41 (describing the cover plates as comprising “a lateral surface [with] grooves distributed on the ci rcumference and radially penetrating into the lateral surfac es ”); id.

, c ol. 5, ll. 10

– 14 (disclosing an embodiment wherein the cover plates have “grooves distributed on the circumference and radially protruding into the lateral surfac es ”); id.

, c ol. 5, ll. 65

– 67 (describing an embodiment with the fiber system “anchored on the c over plates by means of groo ves” ). Claims 29

– 31 recite a “plurality of openings” used to “join” or “anchor” the fiber system to the cover plates , which Synthes contends support s any type of openings located anywhere on the plates

. The written description, however, never discloses anything broader than using grooves to anchor the fiber system to the cover plates.SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 14

The parties appear to agree that “grooves” are a sp ecie s of “opening,” but do not agree that “grooves” const itute an ade quate disclosure to claim all openings that may be used in the cover plates to anchor the fiber sy stem. In other words, the jury was asked to determine whether the written description disclosure of “grooves” “reasonably convey[ed] to those skilled in the art that the inventor had possession of [an intervertebral implant that could utilize any sort of opening located anywhere on the cover plates to anchor the fiber system] as of the filing date.” Ariad , 598 F.3d at 1351. The jury did not believe so and, w hen all reasonable inferences are drawn in favor of the jury verdict, we must affirm that decision.
SK presented testimony regarding the plurality of openings limitation via its expert

, Dr. Lee

, and its r esearch and development manager, Mr. Koske. Dr. Lee testified, based on his experience in designing total disc replacements, that a person of ordinary skill in the art would not believe that Synthes had possession of an intervertebral implant utilizing openings located an ywhere on the cover plates based on the disclosure of peripheral grooves in the written description. In partic ular, Dr. L ee testified that: (1) based on his reading of the written description, the disclosure of peripheral grooves would not disclose openings located anywhere on the plates ( see J.A. 20843

– 54, Tr. Transcript, Jan. 20, 2011 at 2453:24

– 2455:7); (2) there are significant biomechanical property differences between using peripheral grooves and interior slots ( see id. at 2456:11

– 20); and (3) when the fiber system is attached via per ipheral grooves, the di stance of the fibers to the central axis is limited, but when openings are used anywhere on the cover plates, the fibers are not so limited in proximity to the central axis of the device ( s ee id. at 2456:21

– 2458:10 ).

Mr. Koske buttr essed Dr. Lee’s testimony that, based on his direct experience developing the accused products

, the process of moving from peripheral grooves to internalSYNTHES USA , LLC v. SPINAL KINETICS , INC

. 15

slots is not a simple substitution, but a careful and time

consuming task. Mr. Koske, for example, te stified that SK rejected early prototypes that used peripheral grooves on the cover plates. See J.A. 20757 –58, Tr. Transcript, Nov. 20, 2011, 2076:2 1– 2078:20 . Mr. Koske was presen ted with a photograph of various SK devices, which he described as a “design time line” of M6 devices. See J.A. 20757, Tr. Transcript, Nov. 20, 2011, 2075:16

– 24 ; J.A. 27122 (DX1106) . Mr. Koske then testified that the “early prototypes” with peripheral grooves were repeatedly rejected. See 20757

– 78
, Tr. Transcript, Nov. 20, 2011, 2077:11

– 2081:3 . Mr. Koske’s testimony and attendant trial exhibits demonstrated that SK’s development pr ocess from the peripheral grooves to the commercial pro ducts took months of work. See

, e.g. , J.A. 24054

– 56 (SK meeting minutes from September 2003 describing M6 devices in development process); J.A. 24122

– 42 (SK presentation from December 2003 illustrating design history of the M6 devices); J.A. 20758, Tr. Transcript, Nov. 20, 2011, 2081:4

– 12 (Koske testimony regarding A pril 2004 slide show depicting design of M6 at the time).

Mr. Koske also testified that SK had to overcome technical hurdles through its development process, one of which was to reduce wear on the device. Because the devices may be used on people in the ir 20s and 30s and would be required to last a lifetime, wear was an i mportant consideration in design choice. See J.A. 20736, Tr. Transcript, Nov. 29, 2011, 1991:15

– 1993:3 . In pa rtic u lar, Mr. Koske stated that the shape of the slots on the cover plates played a role in wear reduction. Mr. Koske explained that, because the metal cover plates are very thin, if the slots were too large, it would increase the risk of the cover plates breaking. See J.A. 20737, Tr. Tra nscript, Nov. 29, 2011 , 1996:10

– 1997:12

. SK, therefore, had to determine the precise size and location of the slots to ensure that the cover plates used as little metal asSYNTHES USA , LLC v. SPINAL KINETICS , INC

. 16

possible, reduced fiber wear, and still performed all of the necessary functions of the device. Id.
Taken together, Mr. Koske’s testimony is at least ci rcumstantial evidence that it would not be evident that peripheral grooves on the cover plates would disclose to skilled artisans that internal slots would serve the same function. Mr. Koske’s testimony and the exhibits use d during it , coupled with Dr. Lee’s testimony, provided ample evidence for the jury to conclude that the written description did not support the broad claim limitations in the asserted claims. Synthes contends that the difference Dr. Lee ident ified is “spe cious.” Rather than provide contrary evidence, however, Synthes points to a very curt cross

- examination wherein Dr. Lee agreed with Synthes’ counsel that deeper
grooves— or grooves cut deeper into the cover plates

— might reduce the distance of the fibers from the central axis. J.A. at 20889; Tr. Transcript , Dec. 5, 201 1, 2601:16

– 23

. Synthes’ cross

- examination , however, does not a ddress any of Dr. Lee’s other points

. And, even if Synthes’

cross

- examination of Dr. Lee would allow us to draw a different conclusion, so long as substantial evidence supported the jury’s verdict, we must affirm its decision. See First Nat ’l Mortg. Co.

, 631 F.3d at 1067

– 68 ; see also Guy v. City of San Diego , 608 F.3d 582, 588 (9th Cir. 2010) (“[I]t has l ong been held that a jury may properly refuse to credit even uncontradicted testimony.”) (cit ations omitted); Watec Co. v. Liu , 403 F.3d 645, 651 n

. 5 (9th Cir. 2005) (“We will not weigh the evidence or assess the credibility of witnesses in determining wh ether su bstantial evidence exists.”) (citations omitted).
Synthes also attempts to minimize the relevance of Mr. Koske’s testimony by contending that his testimony was not directed to differences between using peripheral grooves and internal slots. Mr. Ko ske, however, testified that the shape and size of the slots

, and the optimizationSYNTHES USA , LLC v. SPINAL KINETICS , INC

. 17

of those slots , were important design consideration s . And, while Synthes is correct that Mr. Koske did not u se “ ma gic words ” to explain why SK chose internal slot s instead of peripheral grooves, t he jury was free to d raw its own conclusions from Mr. Koske’s testimony. C oupled with Dr. Lee’s expert testimony on the “plurality of openings” limitation, the jury’s verdict that a person skilled in the art would not understand th at a disclosure of peripheral grooves would teach that any and all openings on the cover plates are disclosed is supported by substantial evidence

. The jury was entitled to rely on the above testimony and evidence to conclude that the ’270 patent ’s written description does not support the broad plurality of ope nings limitation

. W ritten description is a factual question, and whether the requirement is met “varies depending on the nature and scope of the claims and on the complexity and predictabilit y of the relevant technology.” Ariad , 598 F.3d at 1351. While the predictability of the “aspect at issue” is not the dispositive factor in determining whether the writte n description requirement is satisfied , the district court relied on it, and S ynthes strenuously di sputes the district court’s conclusion. We , thus, briefly address it. Id.

S ynthes frames the “aspect at issue” as “the shape and locations of openings used to join or anchor a fiber system to a plate.” Synthes’ Reply Brief at 46. As chron icled above, Dr. Lee testified that the difference between peripheral grooves and internal slots would present significant engineering and design choices and mai ntained that the differences between the two designs would present substantial biomechanical di fferences. Mr. Koske also explained that SK itself began its development process with peripheral grooves and ended with internal slots. Mr. Koske ’s testimony also indicated that the shape of the internal slot s was an important design choice thatSYNTHES USA , LLC v. SPINAL KINETICS , INC

. 18

required testing to account for wear on the fiber system

. All of this testimony was unrebutted.

Based on this evidence, t he jury was free to conclude that

, because the ’270 patent’s written description does not disclose anything oth er than peripheral grooves, there would be significant biomechanical differences between using periph eral grooves and internal slots. T he jury was also free to determine that SK’s skilled artisans made a specif ic design choice to change its first prototype with peripheral grooves to specifically shaped and located internal slots. And, t he jury was free to conclude , based on the evidence, that the use of internal slots for thes e devices was not predictable. SK is correct that a “disclosure of a species may be sufficient written description support for a later claimed genus including that species.” Bilstad v. Wakalopulos

, 386 F.3d 1116, 1124 (Fed. Cir. 2004) (emphasis added). But, as we stated in Bilstad : [i]f the difference between members of [a species] is such that [a] person skill ed in the art would not readily discern that other [species] of the genus would perform similarly to the disclosed members, i.e., if the art is unpredictable, then disclosure of more species is necessary to adequately show po ssession of the entire genus.

I

d. at 1125. In other words, predictability is a factual issue judged on a ca se

- by

- case basis . Here, SK presented its case to the jury, and the jury inferred that

, in the field of intervertebral implants

, the disclosure of peripheral grooves does not adequately demonstrate possession of the entire genus of possible openings. B ecause the jury’s verdict is sup ported by substantial evidence, we must defer to that finding.
Synthes contends that

, because we remarked in Bilstad that the “mechanical world” is a “fairly predict a-SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 19

ble field,” SK ha d to satisfy a heightened burden to demonstrat e unpredictability. See Bilstad , 386 F.3d at 1126. First, SK had no higher burden than providing cle ar and convincing evidence that the ’270 patent does not satisfy the written description requirement on the “plurality of openings” limitation

. Second, while we did
state in Bilstad that the mechanical field was “fairly predicta ble, ” we did not hold that all inven tions that may be characterized as “ mechanical ” allow claimi ng a genus based on disclosure of a single species

. As we noted in Ariad , there are no “bright

- line rules governing, for example, the number of species that must be disclosed to describe a genus claim, as this number necessarily changes with each inventi on, and it changes with progress in a field.” Ariad , 598 F.3d at 1351. I ndeed, factual inquiries will , at times, create confounding

res ults . But, whatever inconsistencies may appear “to exist in the application of the law, those inconsistencies
rest not with the legal standard but with the different facts and arguments presented to the court s .” Id. at 1352. That is precisely the situation here. After hearing all of the testimony and evidence, the jury resolved the facts in favor of SK and determined t hat it had met its burden of proving by clear and convincing evidence that the ’270 patent did not satisfy the written description requir ement. Again, w e are not entitled to disturb that finding when there was substantial evidence to support it

. 2. Exceptional Case
Attorney s’ fees may be awarded to the prevailing party in “exceptional cases.” 35 U.S.C. § 285. The exce ptional nature of a case must be established by clear and convincing evidence. Brooks Furniture Mfg., Inc. v. D utailier, Int’l Inc. , 393 F.3d 1378, 1382 (Fed. Cir. 2005). Absent litigation misconduct, sanctions may be imposed only if: (1) the litigation is brought in subjective bad faith, and (2) the litigation is objectively baseless. Id. at 1381.SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 20

In deciding whether a case is exc eptional, trial courts are to consider the “totality of the circumstances” surrounding not just the initial allegations of infringement, but the maintenance of those claims throughout the litigation. See MarcTec, LLC v. Johnson & Johnson , 664 F.3d 907, 91 5– 19 (Fed. Cir. 2012). Thus, when information gleaned from discovery or the court’s rulings make clear that the continued pursuit of litigation is frivolous or vexatious, fees may be warranted even where the filing of the initial complaint was arguably ju stified. See id.
SK contends that Synthes brought objectively bas eless allegations of infringement and va lidity and conti nued to push those claims in the face of facts and claim construction rulings that made clear that Synthes’ claims were unsupportable

. SK alleges that Syn thes engaged in litigation miscond uct by taking a number of baseless positions on everything from its claim construction arg uments to its damages theory

. SK contends that the di strict court’s view of Synthes’ conduct was too myopic, failing to examine the propriety of its conduct as a whole. After an independent re view of the record

— in its entir ety —w e agree with the district court that SK failed to demonstrate with clear and convincing evidence that it is entitled to attorney fees un der § 285. See Synthes , ECF No. 5 77 (N.D. Cal. Sept. 27, 2012).

III. C ONCLUSION Based on the foregoing, we affirm the distri ct court’s denial of JMOL that claims 29

– 31 of the ’270 patent are i nvalid under 35 U.S.C. § 112, paragraph 1 for lacking an adequate disclosure to support the “plurality of openings” limitation. We also affirm the district court’s denial of SK’s request for attorney s’ fees under 35 U.S.C. § 285. Accordingly, we need not reach the other issues addressed by the district court and addressed by the parties in the briefing before this court.

AFFIRMED

# United States **Court of Appeals**  **for the Federal Circuit**

______________________ SYNTHES USA, LLC ( formerly known as Synthes (U.S.A.)) AND DEPUY SYNTHES PRODUC TS, LLC, Plaintiffs

- Appellants,

v.

SPINAL KINETICS, INC ., Defendant

- Cross Appellant.

______________________

2013

- 1047,

- 1059

______________________ Appeals from the United States District Court for the Northern District of California in No. 09

- CV

- 1201, Senior J udge Ronald M. Whyte.

______________________

T ARANTO , Circuit Judge

, dissenting

. In my view, Spinal Kinetics failed as a matter of law to show , by clear and convincing evidence, that asserted claim s 29

- 31 of Patent No. 7,429,270 are invalid for inadequa cy of th e written description. In particular, Spinal Kinetics offered no clear and convincing proof that the difference between the “openings” of the claims and the grooves of the written description is one that (in the eyes of skilled artisans) ha s any eff ect, let alone an effect that is difficult to predict, on fulfillment of the identified purposes of the claims at issue. Nor is there any basis for finding the written description inadequa te to support the “flexible core” limitation (or one other limitati on for whichSYNTHES USA , LLC v. SPINAL KINETICS , INC

. 2

the district court itself rejected Spinal Kinetics’s written

description challenge )

. I therefore respectfully dissent from the majority’s affirmance of the judgment that the patent claims are invalid.
Regarding the judgment of noninfringement, which must be addressed if the invalidity judgment is reversed, I conclude that the district court relied on an erroneous construction of the claim term “fiber system .” That error cannot be disregarded as one we can be confident had no effect on the verdict of noninfringement , for the usual simple reasons. The jury did not specify that it found noninfringement on a basis other than the incorrectly construed limitation ; t here is ample (perhaps conclusive) evidence that th is limitation is met under the proper construction ; and there is sufficient evidence to have allowed the jury to find that the other limitations are met

. The jury verdict of noninfringement therefore must be

v acated. Accordingly, I would remand the case for a determination, presumably through a new trial, of whether the accused products infringe under the proper claim construction

. I

A

T he written

- description challenge in this case is to structural claim language that is broader than the specific embodiments disclosed in the written description. This is
not a case

— such as some cases in volving genetic or che mical inventions

— in which the claim language at issue is functional rather than an identifier of structure. See, e.g.

, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. , 598 F.3d 1336, 1349

- 50 (Fed. Cir. 2010) ; Regents of University of California v. Eli Lilly & Co. , 119 F.3d 1559, 1568 ( Fed. Cir. 1997)

. Nor is it a case in which the claim language includes details that do not appear in the written descri ption. See

, e.g. , Purdue Pharma L.P. v. Faulding Inc. , 230 F.3d 1320, 1327 (Fed. Cir. 2000). The written

- descriptionSYNTHES USA , LLC v. SPINAL KINETICS , INC

. 3

question here is the familiar one involving whether the claim language is simply too broad given the disclosure

— notwithstanding that claim language may be and co mmonly is broader than described embodiments, as it identifies what aspects of the disclosed embodiments
matter. See In re Rasmussen , 650 F.2d 1212, 1215 (CCPA 1981) (“[T] hat a claim may be broader than the specific embodiment disclosed in a specification is in itself of no moment.”) ; Ronald Slusky, Invention Analysis and Clai ming: A Patent Lawyer’s Guide at 32

- 33 (2007) (discussing claim draftin g process of identifying what features of embodiment matter )

. In a case like this one, the written

- description r equirement must focus on whether the way in which the (broader) claim term differs from the (narrower) discl osure is pertinent to fulfilling the identified purposes of the claims at issue. More specifically, for a challenger to prove insufficiency of the written description to support the claim language, the challenge r must identify the respect in which the clai m language differs from the disclosed embodiments. At a minimum, t he challenger must then demonstrate that, in the eyes of a relevant skilled artisan, that particular difference has a material effect on whether the product or process would achieve the aim s of the claims at issue , with materiality of the effect not the same as non

- obviousness but related to predictability (this case requiring no further definition of that relation). S ee Ariad , 598 F.3d at 1351 , 13 52; Bilstad v. Wakalopulos , 386 F.3d 1116, 11 24

- 25 (Fed. Cir. 2004) (inquiry into whether skilled artisans “would not readily discern that other members of the genus would perform similarly to the disclosed members, i.e. , if the art is u npredictable”); In re Curtis , 354 F.3d 1347, 1355
, 1358 (Fed. Cir. 2004) (inquiry into whether skilled artisan “could not predict the operability in the invention of any species other than the one disclose d ”; focus on “unpredic tability in performance”); Rasmussen , 650 F.2d at 1215SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 4

( inquiry into whether difference fro m described embod iment is “unimportant” to operability ). 1 It is commonly true , of course, that a skilled artisan has to make some judgments when seeking to implement the patent, whether it is the described embodiments or an undescribed embodiment of the broader claim that the artisan is proceeding to make and use. If those judgments are sufficiently unguided by the written description, unknown to a skilled artisan , or uncertain (requiring undue experimentation)

, at least an enablement problem may arise —t hough there is no enablement challenge here. What is critical for present written

- description purposes is th is: if there is materially the same range of impleme ntation judgments for the described embodiments and the broader claim

— such as, here, how many o penings/grooves to have, the ir shape, how close to the center and far from the periphery they would locate the fibers passing through

— the need for such judgments is i rrelevant to the written

- description question . What matters is only the particular differ ence between the narrower embodiments and broader claims

. Recognizing the burden of proof carried by the cha llenger, t his approach implements the Ariad formulations: whether the inventor “ possessed the claimed invention ,” or “ actually invented the invention claimed .” 598 F.3d at 1351, 1355

- 56. If the challenger does not make the sho wing identified above, the relevant skilled artisan will understand that, by expressly describing certain embod i1 A patent’s written description may describe more than one purpose or problem to be solved, and a partic ular claim may not address all of them. See

, e.g. , Phillips v. AWH Corp. , 415 F.3d 1303, 1327 (Fed. Cir. 2005) (en banc). T he written

- description analysis of a particular claim must focus on the purposes and problems relevant to that particular claim.SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 5

ments, the inventor possessed the more broadly claimed i nvention, because the differences are immaterial to what the inventor invented. See In re Peters , 723 F.2d 891, 893 (CCPA 1983) ( reversing claim rejections that were based

on a differ ence between the broader claim terms and the narrower disclosure, becaus e “[m]ost importantly, one skilled in the art would readily understand that in pra cticing the invention [the difference] is unimportant ”). If the challenger has made the identified showing, the relevant skilled artisan will understand that the inventor ha d not (based on the disclosure) addressed issues of consequence to fulfilling the invention’s purpose, and so did not possess in full the broadly claimed invention. See Ariad , 598 F.3d at 1353 (“ Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of ‘invention’

— that is, conceive of the complete and final invention with all its claimed limitations .”).
At the same time, this approach aligns with a critical role of the written

- description requirement in a case involving a question of breadth. In such a case, the requirement serves to prevent an inventor from acquiring exclusivity rights over potential pr oducts or processes that present problems in achieving the invention’s aims that he or she has not solved

. See Fiers v. Revel , 984 F.2d 1164, 1171 (Fed. Cir. 1993) (“ attempt [s] to preempt the future before it has arrived ” are “ not in compliance with the d escription requirement ”). It thus confines patents to the problems the inventor solved and leaves to other people the solutions they identify that the inventor did
not.

B
In this case, Spinal Kinetics failed to present the proof required to show an in sufficient written description. The difference between the claimed “openings” and the di sclosed “grooves” is simply that , for a groove, the spaceSYNTHES USA , LLC v. SPINAL KINETICS , INC

. 6

remains open at the perimeter whereas, for an “opening,” it need not be: “opening” covers slots wholly interi or to the outer boundary of the p late

. But Spinal Kinetics did not prove that that difference

— potential closure at the p erimeter— had any effect on the ability of the invented implants to fulfill their purpose.
The evident role of the grooves is to prevent sideways movement of the fibers

, along the perimeter of the plate

, as they hold the components of the implant together. See ’270 patent at col. 3, l ines 27

- 30 (“By guiding the fibres in the grooves the fibre system can be so anchored on the cover plates , that in the case of tensile forces acting on the fibres no slipping of the fibres on the lateral sides is poss ible .”) (emphasis added). Nothing in Spinal Kinetics’s proof showed that closing the space at the perimeter affects that function (let al one in an unpredictable way)

. More generally, nothing in Spinal Kinetics’s proof showed that the difference between grooves and interior openings was material to the working of the claimed device. The two witnesses on which Spinal Kinetics relies for its written

- description challenge are its expert, Dr. Lee, and its Research and Development Manager

, M r. Koske. Neither they, nor the documents on which they relied, showed (by clear and convincing evidence) how the way in which “openings” differ from “groov es” makes any mater ial difference to the working of the claimed device

. Dr. Lee ’s key testimony was his statement that “the
stress or strain on the fiber s” is affected by wheth er the fibers pass through the plate near the center or near the perimeter. See J .A. 20853 ( Tr. 2456 : 11

- 2458:11 )

. But

, decisively, the distance from the center (or perimeter) is not the respect in which “openings” differ from “grooves .” Whether the space at the perimeter remains open (as with grooves) or closed (as with openings) p lays no role in determining how far from (or near to) the center the fiber s pass through the plate : if a groove extends deep toward the center, the fibers will pass through the plate there,SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 7

just as they will if openings are placed at that location. Dr. Le e’s testimony, not addressing the difference b etween openings and grooves, is irre levant to the analysis. Nothing else Dr. Lee said makes up for the irrel evance of the foregoing testimony. He testif ied that he could not find the word “openings” in the spe cification, see Joint App. 20852 (Tr. 2453:1

- 13 ) , but that is itself of no importance: the written

- description requirement is about support in substance, not about labels. Kao Corp. v. Unilever U.S. , Inc., 441 F.3d 963, 967

– 68 (Fed. Cir. 2006)

. Dr. Lee also stated that there was a “significant difference

. . . in biomechanical properties” between the broader claim term and the narrower disclosure. See Joint App. 20853 (Tr. 2456:11

- 2458:11 ). But without the eventual identification of what differ ence in properties he meant, that sentence is entirely a conclusory opinion, which is insufficient to meet a burden of proving facts by clear and convincing evidence. See

, e.g. , Active Video Networks, Inc. v. Verizon Comm’ns, Inc. , 694 F.3d 1312, 1327, 13 30

- 31 (Fed. Cir. 2012); Krippelz v. Ford Motor Co. , 667 F.3d 1261, 1269 (Fed. Cir. 2012) ; Ashland Oil, Inc. v. Delta Resins & Refractories, Inc. , 776 F.2d 281, 294 (Fed. Cir. 1985)

. It was only the distance

- from

- center testimony discussed just above that gave any concrete factual co ntent to the otherwise- conclusory assertion, but that basis, as shown, is irrelevant to the required analysis.

M r. Ko ske likewise did not present the required proof

, either through his testimony or through the exhibits about wh ich he testified. That evidence established that, at one point, Spinal Kinetics had one or more prototype s with grooves ( and many other features) and that it eve ntually settled on a design that had interior openings (and many other features). But n owhere did M r. Koske testify

, and nowhere do the exhibits show, that the earlier prot otypes were rejected because they had grooves as opposed
to interior openings or that the Spinal Kinetics product

development process focused on that difference

. See J .A.SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 8

20757

– 78 ( Tr. 2076:21

– 2081:13 )

. The evidence identifies “technical hurdles” involving whether to use fibers or adhesive to anchor the fiber system to the cover plates, see J .A. 20736 ( Tr. 1991:15

- 1993:3 )

, and concerns about what shape the interior openin gs should be to preserve disc strength, J .A. 20737 ( Tr. 1996 :10

- 1997 :12) , but none of the evidence addresses the differences between grooves and interior openings in relation to those or any other issues

. In none of the testimony of M r. Koske or the docum ents cited by Spinal Kinetics, Brief for Appellee at 51

- 52
, or the evidence cited by the majority opinion (at 15

- 16) is there any indication about how much if any exper imentation or study Spinal Kinetics did to choose between interior openings and grooves or about any material challenges encountered when considering use of interior openings versus grooves (there can be a plurality of e ither, and each can cause the fiber location to be almost anywhere in the plate)

. In my view, t his is not clear and convin cing evidence.
Spinal Kinetics thus failed to establish the i mportance of the openings/grooves difference . And that conclusion is rein forced indirectly b y the patent itself

— specifically, by the fact that the written description is not actually limited to using grooves for the fibers. The majority states that the specification “discloses a series of examples of how the fiber system may be anchored on the cover plates” and that “[a] ll of these examples employ

‘ grooves,’ not slots or openings on the plates.” Maj. Op. at 13. But the specification, while reciting grooves in some of the examples it gives for how “anchoring of the fibres on the cover plates can be carried out,” includes other examples that are described without any mention of grooves at all. ’ 270 patent at c ol. 3, lines 22

- 62. One separately stated example simply calls for “adher ing the fibre system on the cover plates,” while another calls for join the plates “in a form

- locking manner.” Id. at lines 35SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 9

& 42

- 44. Thus, grooves are not part of all of the ancho ring embodiments disclosed in the ’270 patent

. C
The jury verdict of insufficient writ ten description for the claim at issue cannot be supported on any other ground. On appeal, Spinal Kinetics argues that substa ntial evidence suppor ts finding that two other claim limit ations

— “substantially rigid bone contacting plate” and “flexible core”

— lack adequate written

- description su pport. The district court rejected the first contention but accepted the second. Both contentions are meritles s. Spinal Kinetics did not prove that the specification, which discloses “closing plates” that “are made from titanium or a titanium alloy,” ’270 patent, col. 6, lines 4- 5, fails to adequately describe the claimed “substantially rigid bone contacting plate .” The cover plates, as stated in the specification, are “anchor[ed to] the fibre system” in order to ensure “ the intervertebral implant remains stable even under the greatest loads and the fibre system is capable to withstand even considerable tensile fo rces .” ’270 patent, col. 2, lines 35

- 37. Spinal Kinetics argues that the written description is inadequate because nowhere but the claims does the specification use the terms “rigid” or “substantially rigid.” But the “disclosure as originally filed does not . . . have to provide in haec verba support for the claimed subject matter at issue,” Cordis Corp. v. Medtronic AVE, Inc. , 339 F.3d 1352, 1364 (Fed. Cir. 2003), and Spinal Kinetics failed to present any evidence, much less clear and co nvi ncing evidence, either (1) that the titanium closing plates described by the specification and depicted in Figures 3 and 4 were not “substan tially rigid ” or (2) that a skilled artisan, reading the description of the properties and functions of the closing plates ( i.e. , titanium closing plates used to stabilize the intervertebral implant), would not reliably predict that “substantially rigid” closingSYNTHES USA , LLC v. SPINAL KINETICS , INC

. 10

plates achieve the desired properties of the claimed d evice. See In re Smythe , 480 F.2d 1376, 1383 (CCPA 197 3) (“[T]he specification clearly conveys to one skilled in the art that in this invention the characteristics of a fluid are what make the segmentizing medium work in this inve ntion.”)

. For the “flexible core” limitation, Spinal Kinetics rests its challeng e on the claim term’s purported incompatibi lity with the disclosure of “an elastically deformable formed body . . . with an incompressible core, preferably a liquid core.” ’270 patent, col. 5, lines 15

- 17. This arg ument, though the district court accepte d it, is plainly incorrect. An “incompressible core” is in no way irreco ncilable with a “flexible core.” Incompressible and flexible simply do not conflict : a squeezed balloon that readily deforms while maintaining a constant volume is simult aneously fle xible and incompressible. Thus, the jury could not have reasonably concluded that

, because t he patent specifically discloses an “incompressible core,” the inve ntion could not also include a “flexible” core.
Accordingly, I conclude that there has been no c lear and convincing evidence that the written description inadequately describes the claim ed inventions. I would reverse the district court’s denial of judgment as a matter of law that Spinal Kinetics failed to prove invalidity.

II

As to the judgment of n oninfringement , I conclude that it relies on an incorrect construct ion of the claim term “fiber system .” Th e error could well have been the basis for the jury verdict , which therefore must be vaca ted. The case should be remand ed for further proceedings

on whether the accused products infringe under the proper claim construction.

T he district court construed “fiber system” as “a co llection of fiber strands joined to the third and fourthSYNTHES USA , LLC v. SPINAL KINETICS , INC

. 11

plates and capable of absorbing tensile for ces and co nstraining radial expansion of the flexible core.” Synthes USA, LLC v. Spinal Kinetics, Inc. , No. C

- 09

- 01201, 2010 WL 2573379, at *7 (N.D. Cal. June 23, 2010). That i mportation of functional requirements is incorrect, because the term “fiber system” is entirely a structural one

. “Where a claim uses clear structural language, it is ge nerally improper to interpret it as having functional r equirements .” Schwing GmbH v. Putzmeister Aktiengesellschaft , 305 F.3d 1318, 1324 (Fed. Cir. 2002); accord T oro Co. v. White Consol. Indus., Inc. , 266 F.3d 1367, 1371 (Fed. Cir. 2001) (“An invention claimed in purely structural terms generally resists functional limitation.”). Spinal Kinetics offers no convin cing reason to deviate from the general rule in this case

. Spinal Kinetics notes (correctly) that the specification ascribes functions to the “fiber system,” including to constrain the radial expansion of the core that it su rrounds, see, e.g. , ’270 patent, col . 1, lines 26

- 34, but that is not a reason to add those functions to the simple, clear “fiber system” of the claim. Where the claim’s structural definition of a term leave s ambiguities, such as an u naddressed question of degree, this court has said that “it is ‘ entirely proper to consider the functions of an inve ntion in seeking to determine the meaning of particular claim language. ’” ICU Med., Inc. v. Alaris Med. Sys., Inc.

, 558 F.3d 1368, 1375 (Fed. Cir. 2009) ( quoting Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 ( Fed. Cir. 2005) ) . No such ambiguity exists her e. Claim 29 requires that the “fiber system” (1) “at least partially surround[] the core,” (2) “is at least partially received within the plurality of openings formed in the third and fourth plates so that th e fiber system is joined to the third and fourth plates,” and (3) is “at least partially surround[ed]” by “an elastic sheathing body.” ’270 patent, col. 8, lines 41

- 47. Spinal Kinetics points to no open ques tions for which the claim itself “does not sugg est” an answer. See ICU Med.

,SYNTHES USA , LLC v. SPINAL KINETICS , INC

. 12

558 F.3d at 1375

- 76. The term “a fiber system” is a straightforward structural limitation that needs no fu rther construction

, much less the addition of functional qualifiers

. See O2 Micro Int’ l Ltd. v. Beyond Innovation Tec h. Co ., Ltd. , 521 F.3d 1351, 1362 (Fed. Cir. 2008)

. Because the jury was given a flawed claim constru ction, and th ere was no separate jury finding of noni nfringement on another ground and the jury could easily have found the “fiber system” element satisfied under the correct construction, the verdict of noninfringement must be vacated. See August Tech. Corp. v. Camtek, Ltd. , 655 F.3d 1278, 1286 (Fed. Cir. 2011)

. At the same time, Synt hes has not shown that it is entitled to judgment of infringement, i.e. , that no jury could now reasonably find noninfringement , considering all of the claim limitations at issue, under proper instructions

. Therefore, the judgment of noninfringement shou ld be vacated and the case remand ed to the district court. I would not further constrain the district court’s discretion about how to proceed on remand, including what might be decided on new summary judgment motions and whether to reconsider any evidenti ary rulings that might be seen in a different light in any new trial. And, regarding the

cross

- appeal filed by Spinal Kinetics to challenge the district court’s denial of its motion for attorney ’ s fees , it suffices to say that my view of Synthes’s appeal would mean that Spinal Kinetics would no longer meet even the threshold condition of being a prevailing party

.