Categories: 112 - Written Description Date: Oct 30, 2013 Title: Synthes v. Spinal Kinteics: No Written Description when Single Species Disclosed and Additional Species Are 'Fairly Unpredictable' in the Art
|Title||Synthes USA, LLC v. Spinal Kinetics, Inc., No. 2013-1047, -1059 (Fed. Cir. Oct. 29, 2013).|
| [With regards to phrase “the third plate including a plurality of openings,”] [t]he parties appear to agree that “grooves” are a species of “opening,” but do not agree that “grooves” constitute an adequate disclosure to claim all openings that may be used in the cover plates to anchor the fiber system. 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. |
Synthes at *14 (text added).
| Synthes contends that, because we remarked in Bilstad that the “mechanical world” is a “fairly predictable field,” SK had to satisfy a heightened burden to demonstrate unpredictability. See Bilstad, 386 F.3d at 1126. 18-19|
Id. at *18-19.
| [A]s we stated in Bilstad: [i]f the difference between members of [a species] is such that [a] person skilled 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 possession of the entire genus. Id. at 1125. […] 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 [because the specification was silent on mentioning other "opening" species, and the Expert Testimony supported the finding that other species under the genus are not fairly predictable].|
Synthes at *18 (text added).
| [The comment in Bilstead is not a blanket statement for the entire mechanical world because,] [a]s 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 invention, and it changes with progress in a field.” Ariad, 598 F.3d at 1351. |
Id. at *19 (text added).
|Procedural History||Synthes USA, LLC and DePuy Synthes Products, LLC (collectively, “Synthes”)1 appeal from a jury verdict find- ing that Spinal Kinetics, Inc. (“SK”) did not infringe claims 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 appeals are timely, and we have jurisdiction under 28 U.S.C. § 1295(a)(1). |
Synthes at *2.
|Legal Reasoning (Prost, O'Malley)|
|Claim 19||29. An intervertebral implant for implantation be- tween an upper and lower vertebrae, the implant having a central axis, the implant comprising: |
a first substantially rigid bone contacting plate having an external surface […]; ￼a second substantially rigid bone contacting plate having an external surface […]; ￼a third plate operatively coupled to the first bone contacting plate, the third plate including a plu￼rality of openings; […].
Synthes at *4.
|Legal Standard: Written Description||￼Section 112, paragraph one of Title 35 requires a patentee to provide a written description that allows a person of skill in the art to recognize that the patentee invented what is claimed. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) […]. “[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. Determination 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. at *12 (some internal citations omitted).|
|Legal Standard: Broadening Claims||While broadening claims during prosecution 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 prod- ucts, as long as the disclosure supports the broadened claims.”) (citing Kingsdown Med. Consultants, Ltd. v. Hollister, Inc., 863 F.2d 867, 874 (Fed. Cir. 1988)).|
Id. at *11-12.
| Broad Claim language (“plurality of openings”) is limited to single species (grooves on the circumference of the claimed cover plates) and not the entire Genus.|
|Broadening Amendment||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 devices were already on the market. [...] The original disclosure claimed and disclosed a plurality of grooves and a plurality of channels, but did not describe “openings” generally. [...]|
Synthes at *11 (internal citations omitted).
|Specification Limited to Single Species||The ’270 patent’s written description, filed on April 14, 2003, discloses that the fiber system may be anchored by various means. See ’270 patent, col. 2, ll. 4–6. The written description then discloses a series of examples of how the fiber system may be anchored on the cover plates, i.e., third and fourth plates. All of these examples employ “grooves,” not slots or openings on the plates.|
Id. at *13.
Expert Testimony 1: Description Limited to Single Species
|Dr. Lee 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 peripheral grooves, the dis- tance 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 (see id. at 2456:21–2458:10).|
Id. at *14.
Expert testimony 2: Additional Species are not "fairly predictable"
|Mr. Koske, for example, testified that SK rejected early prototypes that used peripheral grooves on the cover plates. […] Mr. Koske was presented with a photograph of various SK devices, which he described as a “design time line” of M6 devices. […] Mr. Koske then testified that the “early prototypes” with peripheral grooves were repeatedly rejected.[…] Mr. Koske’s testimony and attendant trial exhibits demonstrated that SK’s development process from the peripheral grooves to the commercial products took months of work. […].|
Id. at *15.
| No heightened Burden to demonstrate unpredictability in "mechanical world"|
|First, SK had no higher burden than providing clear 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 predictable,” we did not hold that all inventions that may be characterized as “mechanical” allow claiming a genus based on disclosure of a single species.|
Synthes at *18.
|Based on the foregoing, we affirm the district court’s denial of JMOL that claims 29–31 of the ’270 patent are invalid under 35 U.S.C. § 112, paragraph 1 for lacking an adequate disclosure to support the “plurality of openings” limitation. |
Synthes at *20.
|The Court also provided an additional discussion on Attorneys Fees. To read said discussion, click here.|
|TARANTO, Circuit Judge, dissenting. Synthes, Taranto Op., at *1.|
|General Grounds||In my view, Spinal Kinetics failed as a matter of law to show, by clear and convincing evidence, that asserted claims 29-31 of Patent No. 7,429,270 are invalid for inadequacy of the 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) has any effect, let alone an effect that is difficult to predict, on fulfillment of the identified purposes of the claims at issue.|
Synthes, Taranto Op., at *1.
|Legal Standard should Focus on Whether Broad Claim Terms Differ from Species Disclosure for "the identified Purposes of Claim at issue"|
Legal Standard, according to Dissent
|In a case like this one, the written-description requirement must focus on whether the way in which the (broader) claim term differs from the (narrower) disclosure 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 challenger must identify the respect in which the claim language differs from the disclosed embodiments. At a minimum, the 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 aims 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).|
Synthes, Taranto Op., at *3 (internal citations omitted).
|What is critical for present written-description purposes is this: if there is materially the same range of implemen- tation judgments for the described embodiments and the broader claim—such as, here, how many openings/grooves to have, their shape, how close to the center and far from the periphery they would locate the fibers passing through—the need for such judgments is irrelevant to the written-description question. What matters is only the particular difference between the narrower embodiments and broader claims.|
Id., Taranto Op., at *4.
|Spinal Kinetics did not prove Differences where Material to Justify Lack of Written Description|
|Generally||In this case, Spinal Kinetics failed to present the proof required to show an insufficient written description. The difference between the claimed “openings” and the dis- closed “grooves” is simply that, for a groove, the space remains open at the perimeter whereas, for an “opening,” it need not be: “opening” covers slots wholly interior to the outer boundary of the plate. But Spinal Kinetics did not prove that that difference—potential closure at the perimeter—had any effect on the ability of the invented implants to fulfill their purpose.|
Synthes, Taranto Op., at *5-6.
|Expert Testimony||The two witnesses on which Spinal Kinetics relies for its written-description challenge are its expert, Dr. Lee, and its Research and Development Manager, Mr. Koske. Neither they, nor the documents on which they relied, showed (by clear and convincing evidence) how the way in which “openings” differ from “grooves” makes any materi- al difference to the working of the claimed device.|
Id., Taranto Op., at *6.
|Specification||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 col. 3, lines 22-62. One separately stated example simply calls for “adhering the fibre system on the cover plates,” while another calls for join the plates “in a form-locking manner.” Id. at lines 35 & 42-44. Thus, grooves are not part of all of the anchor- ing embodiments disclosed in the ’270 patent.|
Id., Taranto Op., at *8-9.