Hologic, Inc. v. Smith & Nephew, Inc.

Decision Date14 March 2018
Docket Number2017-1389
Citation884 F.3d 1357
Parties HOLOGIC, INC., Appellant v. SMITH & NEPHEW, INC., Covidien LP, Appellees
CourtU.S. Court of Appeals — Federal Circuit

Matthew Wolf, Arnold & Porter Kaye Scholer LLP, Washington, DC, argued for appellant. Also represented by Marc A. Cohn; Jennifer Sklenar, Los Angeles, CA.

Michael A. Albert, Wolf Greenfield & Sacks, PC, Boston, MA, argued for appellees. Appellee Smith & Nephew, Inc. also represented by Richard Giunta.

Naveen Modi, Paul Hastings LLP, Washington, DC, for appellee Covidien LP.

Before Newman, Wallach, and Stoll, Circuit Judges.

Stoll, Circuit Judge.

Appellant Hologic, Inc. initiated an inter partes reexamination of U.S. Patent No. 8,061,359, which is owned by Appellees Smith & Nephew, Inc. and Covidien LP (together, "S&N"). S&N's '359 patent claims priority to an earlier-filed PCT application by the same inventor with a nearly identical specification. The U.S. Patent and Trademark Office's Patent Trial and Appeal Board found that S&N's earlier-filed PCT application has sufficient written description to make it a priority document instead of an invalidating obviousness reference. Hologic, Inc. v. Smith & Nephew, Inc. , No. 2016-006894, 2016 WL 6216657 (P.T.A.B. Oct. 21, 2016) (" Board Decision "). Hologic appeals. We affirm.

BACKGROUND

The '359 patent relates to an endoscope and method to remove uterine tissue. Claims 1–3 and 5–7 are at issue in this appeal, and independent claim 1 is representative. Claim 1, partially reproduced below, recites a method of using an endoscope, which includes a "permanently affixed" "light guide" in one of two channels:

1. A method for removal of tissue from a uterus, comprising:
inserting a distal region of an endoscope into said uterus, the endoscope including a valve and an elongated member defining discrete first and second channels extending from a proximal region of the elongated member to the distal region, the second channel having a proximal end in communication with the valve such that fluid from the valve is able to flow into and through the second channel to the uterus, and the first channel having a light guide permanently affixed therein and being sealed from the second channel to prevent fluid from the valve from entering the uterus through the first channel ....

'359 patent, claim 1 (emphasis added).

The figures in the '359 patent are relevant to understanding the disputed claim term "light guide." Figure 2, reproduced below, shows the full device, including the two claimed channels 5 and 6, one of which must have a light guide permanently fixed inside. According to the specification, viewing channel 6 has a lens 13 and can be connected to a light source 8.

Figure 3, reproduced below, shows a cut-away of Figure 2, including viewing channel 6 and lens 13, and depicts light going from the lens into the viewing channel.

Finally, Figure 1a, reproduced below, illustrates a cross section of the endoscope shaft, including the two channels from Figure 2: viewing channel 6 and main channel 5.

The '359 patent specification text and figures are nearly identical to PCT International Publication No. WO 99/11184 ("Emanuel PCT"), to which the '359 patent claims priority.1 After entering the national stage with the Emanuel PCT application in a parent application, S&N filed a divisional application that later issued as the '359 patent. An examiner objected to the application's drawings for not showing the "light guide" required by then-pending claim 1 (discussed above). After an interview with the examiner, S&N addressed the objection by amending the specification to state: "A connection 8 for a light source is also present, for connection to a light guide, such as a fibre optics bundle which provides for lighting at the end of lens 13." J.A. 486 (amendment underlined), J.A. 493 (Applicant's Remarks in Amendment). Compare '359 patent col. 3 ll. 56–58, with Emanuel PCT at 4:34–36. With that amendment, the examiner issued the application as the '359 patent.

After the '359 patent issued, Hologic requested inter partes reexamination of the patent, which the PTO granted. During reexamination, the examiner found that the '359 patent could not claim priority to Emanuel PCT because Emanuel PCT did not provide adequate written description for the '359 patent's claims. Specifically, the examiner reasoned that the disclosure in Emanuel PCT of only a "fibre optics bundle" did not provide adequate written description for the broad genus of "light guides." Thus, the examiner determined that the effective priority date was no earlier than July 20, 2007, and Emanuel PCT, which was published on March 11, 1999, constituted prior art to the '359 patent's claims under pre-AIA § 102(b). Therefore, the examiner rejected claims 1–3 and 5–7 as obvious over Emanuel PCT in view of a secondary reference. S&N appealed to the Board.

The issue before the Board—and before us on appeal—is whether Emanuel PCT, which discloses a "connection to a fibre optics bundle which provides for lighting at the end of lens 13," provides sufficient written description to support the "light guide" "permanently affixed" in the "first channel" of the '359 patent's claims. See Emanuel PCT at 4:34–36. If it does, then the '359 patent properly claims priority based on Emanuel PCT. If it does not, then Emanuel PCT is prior art to the '359 patent and invalidates it as obvious. The Board, after briefing and review of expert testimony, found that the disclosure in Emanuel PCT provides sufficient written description support for the claimed "light guide," entitling the '359 patent to the priority date of Emanuel PCT. Accordingly, the Board reversed the examiner's rejections of the '359 patent's claims.

Hologic appeals the Board's decision. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(4)(A).

DISCUSSION

On appeal, Hologic challenges the Board's priority date determination and urges this court to reinstate the examiner's obviousness determination. Obviousness under 35 U.S.C. § 103 is a mixed question of law and fact.2 We review the Board's ultimate obviousness determination de novo and underlying fact-findings for substantial evidence. Harmonic Inc. v. Avid Tech., Inc. , 815 F.3d 1356, 1363 (Fed. Cir. 2016). Whether an earlier-filed application possesses sufficient written description to qualify it as a priority document or is instead invalidating prior art is a fact-finding we review for substantial evidence. See 35 U.S.C. §§ 112, 120 ; Yeda Research & Dev. Co. v. Abbott GmbH & Co. KG , 837 F.3d 1341, 1344–45 (Fed. Cir. 2016).

I.

To be entitled to the priority date of the earlier-filed Emanuel PCT, S&N must show that Emanuel PCT discloses what the '359 patent claims, according to the written description requirement of pre-AIA 35 U.S.C. § 112 ¶ 1.3 See In re Katz Interactive Call Processing PatentLitig. , 639 F.3d 1303, 1322 (Fed. Cir. 2011). Specifically, based on "an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art ..., the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed." Ariad Pharm., Inc. v. Eli Lilly & Co. , 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). "In other words, the test for sufficiency is whether the disclosure of the [earlier] application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter" as of that earlier filing date. Id. As discussed further below, we find that this standard is satisfied here.

As a preliminary matter, the parties do not dispute the Board's definition of a person of ordinary skill in the art as a "degreed engineer having at least 5 years of experience designing and developing devices used in minimally invasive surgery (endoscopes, resectoscopes

, shavers, tissue removal devices, etc.)." Board Decision , 2016 WL 6216657, at *8. We agree with the Board's finding that the field of this invention is a predictable art, such that a lower level of detail is required to satisfy the written description requirement than for unpredictable arts. See

id. at *13 ; Ariad , 598 F.3d at 1351.

II.

We affirm the Board's reversal of the examiner's rejection because we find substantial evidence supports the Board's finding that the '359 patent is entitled to claim priority to Emanuel PCT. Specifically, substantial evidence supports the Board's finding that Emanuel PCT reasonably conveys to a person of ordinary skill that the inventor had possession of the "first channel having a light guide permanently affixed therein." See '359 patent, claim 1. We address the substantial evidence supporting each element.

First, Hologic argues that substantial evidence does not support the Board's conclusion that the Emanuel PCT disclosure reasonably conveys to a person of ordinary skill that the inventor had possession of a "light guide." While Emanuel PCT explicitly discloses a "fibre optics bundle," it does not explicitly disclose a "light guide." Emanuel PCT at 4:34–36. In finding that Emanuel PCT also discloses a "light guide," however, the Board properly relied on the fact that the parties do not dispute that a "fibre optic bundle" is a type of light guide. Board Decision , 2016 WL 6216657, at *13. Nor did the parties dispute that various types of light guides were well-known in the art. Indeed, the Board correctly found that the declarations of Hologic's own experts did not dispute either point in discussing how one of ordinary skill would interpret Emanuel PCT. See id. (citing Dominicis Decl. ¶ 12 (J.A. 2290), Walbrink Decl. ¶¶ 10(c), 30 (J.A. 2648) ). Accordingly, we conclude that substantial evidence supports the Board's finding that Emanuel PCT reasonably conveys to a person of ordinary skill that the inventor had possession of a "light guide."

Second, Hologic argues that substantial evidence does not support the Board's conclusion...

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