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Hologic, Inc. V. Smith & Nephew, Inc., Covidien LP – text from US Court of Appeals for Federal Circuit

March 14, 2018

in Blog

United States Court of Appeals

for the Federal Circuit

______________________

HOLOGIC, INC.,

Appellant

v.

SMITH & NEPHEW, INC., COVIDIEN LP,

Appellees

______________________

2017-1389

______________________

Appeal from the United States Patent and Trademark

Office, Patent Trial and Appeal Board in No. 95/002,058.

______________________

Decided: March 14, 2018

______________________

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.

HOLOGIC, INC. 2 v. SMITH & NEPHEW, INC.

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

HOLOGIC, INC. v. SMITH & NEPHEW, INC. 3

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.

HOLOGIC, INC. 4 v. SMITH & NEPHEW, INC.

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.

1 The ’359 patent claims priority to Emanuel PCT

via U.S. Patent No. 7,249,602, which issued from the

national stage application of Emanuel PCT. The disclosures

of the ’602 patent and Emanuel PCT are the same

for our purposes, so we focus on Emanuel PCT and its role

in the ’359 patent’s prosecution history.

HOLOGIC, INC. v. SMITH & NEPHEW, INC. 5

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).

HOLOGIC, INC. 6 v. SMITH & NEPHEW, INC.

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 earlierfiled

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 Patent

2 Congress amended § 103 when it enacted the

Leahy-Smith America Invents Act (“AIA”). Pub. L.

No. 112-29, § 3(c), 125 Stat. 284, 287 (2011). However,

because the application that led to the ’359 patent has

never contained (1) a claim having an effective filing date

on or after March 16, 2013, or (2) a reference under

35 U.S.C. §§ 120, 121, or 365(c) to any patent or application

that ever contained such a claim, the pre-AIA § 103

applies. See id. § 3(n)(1), 125 Stat. at 293.

3 Congress also amended § 112 when it enacted the

AIA. AIA § 4(c), 125 Stat. at 296−97. However, the

amended version of § 112 applies only to patent applications

“filed on or after” September 16, 2012. See AIA

HOLOGIC, INC. v. SMITH & NEPHEW, INC. 7

Litig., 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

  • 4(e), 125 Stat. at 297. Because the application that led

to the ’359 patent was filed before that date, pre-AIA

  • 112 applies here.

HOLOGIC, INC. 8 v. SMITH & NEPHEW, INC.

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 wellknown

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 that the Emanuel PCT

disclosure reasonably conveys to a person of ordinary skill

that the inventor had possession of a light guide permanently

affixed in the “first channel.” Hologic’s argument

rings hollow. The first channel is depicted in Figures 2

and 3 as element 6 and is described in Emanuel PCT as a

light channel” or “viewing channel.” See Emanuel PCT

at 3:24–25, 4:30–36 (emphases added). Channel 6 is

further described as terminating in lens 13 at one end and

viewing tube 7, which is an eyepiece or camera connecHOLOGIC,

INC. v. SMITH & NEPHEW, INC. 9

tion, at the other end. Furthermore, the specification

makes clear that the viewing channel is element 6 in

Figure 2. Element 6 is next to connection 8 for the light

source. Additionally, the specification explains that “[a]

connection 8 for a light source is also present, for connection

to a fibre optics bundle, which provides for lighting at

the end of lens 13.” Id. at 4:34–36.

Taken together, these statements in the specification

support the Board’s finding that Emanuel PCT contemplated

a distinct channel for light or viewing, separate

from cutting tools. Accordingly, we find that substantial

evidence supports the Board’s conclusion that a person of

ordinary skill, reviewing the Emanuel PCT figures and

specification, would have understood that the inventor

had possession of a light guide affixed in the “first channel.”

We must also address Hologic’s argument that Figure

1a, which it alleges does not show illumination components,

evidences that the inventor was not in

possession of a “first channel having a light guide permanently

affixed therein” at the relevant time. We disagree

with Hologic’s contention for at least two reasons. First,

that the viewing channel does not depict a light guide or

fibre optics is not dispositive. The written description

does not require that every claimed element be illustrated

in the figures, particularly in predictable arts and where

the element not depicted is conventional and not “necessary

for the understanding of the subject matter sought to

be patented.” 35 U.S.C. § 113 (requiring only that the

“applicant shall furnish a drawing where necessary for

the understanding of the subject matter sought to be

patented”); see also 37 C.F.R. § 1.81(a) (“The applicant for

a patent is required to furnish a drawing of the invention

where necessary for the understanding of the subject

matter sought to be patented.”); In re Hayes Microcomputer

Prods., Inc. Patent Litig., 982 F.2d 1527, 1536 (Fed. Cir.

1992) (concluding substantial evidence supports the

HOLOGIC, INC. 10 v. SMITH & NEPHEW, INC.

finding that a “microprocessor” illustrated in a figure was

sufficient written description support for claimed timing

means and other claim elements not depicted in figures).

Moreover, the lack of an illumination component in Figure

1a does not undermine the strong evidence noted

above that supports the Board’s finding that Emanuel

PCT discloses a light guide in channel 6.

Finally, Hologic argues that the Board’s finding that

Emanuel PCT reasonably conveys to a person of ordinary

skill that the inventor had possession of a “permanently

affixed” light guide lacks the support of substantial evidence.

We disagree. Figure 1 of Emanuel PCT illustrates

a cutting device 1 that may be assembled from multiple

parts. Emanuel PCT at 4:15–16 (“Fig. 1 shows the endoscopic

cutting device according to the invention in the

assembled state.”) Specifically, cutting device 1 is assembled

from three primary parts: (a) viewing/receiving

part 3 (illustrated in Figure 2), (b) cutting part 2 (illustrated

in Figures 4 and 5), and (c) insertion mandrel 40

(illustrated in Figure 6). Id. at 4:17–29. Emanuel PCT

explains that cutting part 2 is removable. Id. at 8:3–8

(“Surgical endoscopic cutting device (1) . . . provided with

a receiving part (5) . . . for receiving cutting means (2)

. . . .”). Similarly, insertion mandrel 40 is removable. Id.

at 5:38–6:1 (“Mandrel 42 is then removed. . . .”). Nowhere,

however, does Emanuel PCT suggest that the fibre

optics bundle of viewing/receiving part 3 is removable.

See id. at 4:26–36. Indeed the specification explains that

viewing/receiving part 3 is composed of an outer tube 4 in

which a main channel 5 and viewing channel 6 are defined.

Id. at Fig. 2, 4:30–32. At no point does the specification

describe the fibre optics bundle component of the

viewing/receiving part 3 as removable. It is connection 8

that enables addition or removal of a light source in

conjunction with the fibre optics bundle. Id. at 4:34–36.

Further, viewing channel 6 ends at one side in a lens 13

and at the other side in a viewing tube 7, on which an

HOLOGIC, INC. v. SMITH & NEPHEW, INC. 11

eyepiece or camera connection is placed. Id. at Fig. 2,

4:30–37. The fact that viewing channel 6 is bookended by

lens 13 and viewing tube 7 is evidence that these components

form a unitary part that is not removable. The

specification also describes a connection 8 for a light

source, for connection to a fibre optics bundle that provides

for lighting at the end of the lens 13. Id. at Fig. 2,

4:30–37. Indeed, Figure 2 shows connection 8 is integral

with the viewing/receiving part 3. Id. at Fig. 2. Taken

together, these disclosures in Emanuel PCT support the

Board’s finding that Emanuel PCT contemplated a “permanently

affixed” light guide. Accordingly, we find that

substantial evidence supports the Board’s conclusion that

a person of ordinary skill, reviewing Emanuel PCT, would

have understood that the inventor had possession of a

“permanently affixed” light guide.

In addition to the intrinsic evidence discussed above,

prior patents reflecting the state of the art at the time of

the invention and expert testimony regarding that evidence

further support the Board’s findings. The

’359 patent on its face lists several pieces of prior art,

including U.S. Patent No. 4,606,330 (“Bonnet”) and U.S.

Patent No. 4,706,656 (“Kuboto”). Bonnet and Kuboto both

describe endoscopes with permanently affixed light

guides. S&N’s experts, Dr. Keith B. Isaacson and

Mr. Richard J. Apley, each testified that the figures in

Emanuel PCT look more like the figures in Bonnet and

Kuboto than figures in several prior art patents directed

to removable light guides. Specifically, Dr. Isaacson

testified that, as of at least September 1998, a person of

ordinary skill in the art would have known that there

were two types of endoscopic systems generally available

for use in surgical procedures: a removable “telescope,” or

a unitary integrated device—like Bonnet and Kuboto.

Dr. Isaacson further testified that the two types of devices

were readily distinguishable merely by looking at pictures

of the devices. Continuing, Dr. Isaacson explained that,

HOLOGIC, INC. 12 v. SMITH & NEPHEW, INC.

in looking at the Emanuel PCT figures, a person of skill in

the art would recognize that they have permanently

affixed light guides and lenses, similar to those shown in

Bonnet and Kuboto. Mr. Apley provided similar testimony.

Hologic argues that the Board improperly relied on

prior art to supply missing claim elements. We do not

agree. The Board simply considered what the specification

reasonably conveys to the skilled artisan who has

knowledge of the prior art. See Ariad, 598 F.3d at 1351.

The Board did not err in this regard.

Hologic likewise argues that the Board did not properly

limit its consideration to the four corners of Emanuel

PCT because the endoscope in Emanuel PCT does not

expressly or “necessarily include a light guide permanently

affixed in a first channel.” Appellant Br. 38 (emphasis

added). Hologic’s understanding of our written description

law is incorrect. Rather, we agree with the Board

that the proper test is the one we articulated in Ariad:

“whether the disclosure of the application relied upon

reasonably conveys to those skilled in the art that the

inventor had possession of the claimed subject matter as

of the filing date.” Board Decision, 2016 WL 6216657,

at *6 (citing Ariad, 598 F.3d at 1351).

For the above reasons, we are satisfied that the Board

applied the correct law and that substantial evidence

supports the Board’s finding that Emanuel PCT provides

sufficient written description disclosure of the claimed

“first channel having a light guide permanently affixed

therein.”

CONCLUSION

We have reviewed Hologic’s remaining arguments and

find them unpersuasive. For the reasons above, we affirm

the Board’s finding that Emanuel PCT provides written

description support for claims 1–3 and 5–7 of the

HOLOGIC, INC. v. SMITH & NEPHEW, INC. 13

’359 patent and that the ’359 patent is entitled to claim

priority to Emanuel PCT. Accordingly, we affirm the

Board’s finding that Emanuel PCT is not prior art to the

’359 patent under pre-AIA Section 102(b). We also affirm

the Board’s reversal of the examiner’s corresponding

obviousness rejection.

AFFIRMED

COSTS

Costs to Appellees.

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