Opposition Brief — Ormco Corp. Corp. v. Align Technology Technology Technology, Inc. (No. 07-1070)

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No. 07-1070 | APR 1 - 203

IN THE

Supreme Court of the Wnited States

ORMCO CORPORATION,

Petitioner,

v.

ALIGN TECHNOLOGY, INC.,

Respondent.

On PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES Court OF APPEALS

FOR THE FEDERAL CIRCUIT

BRIEF IN OPPOSITION

DANIEL J. FuRNISS

Counsel of Recoeg

ANNE M. RoGaski

Nancy L. ToMPKINS

TOWNSEND AND TOWNSEND

AND CrEw LLP

379 Lytton Avenue

Palo Alto, California 94801

(415) 326-2400

Counsel for Respondent

215104 cr

COUNSEL PRESS

(800) 274-3321 * (800) 359-6859

z

QUESTIONS PRESENTED

1. Whether the Federal Circuit correctly held that

multiple and unambiguous statements in the common

specification of the asserted patents disparaging and

differentiating a key feature of the prior art operate to

disavow that feature from the scope of the claimed

inventions, particularly where the statements do not

conflict with the text of the patent claims.

2. Whether, as petitioner conceded below, sweeping

disavowals of reliance on “human decision making” to

determine final tooth positions, which the applicants

made to the Patent Office in order to distinguish cited

prior art and thereby win allowance of the parent to the

asserted continuation patents, are relevant to the

interpretation of the asserted patent claims containing

“linking language” relating directly to the disavowed

feature.

ii

CORPORATE DISCLOSURE STATEMENT

Pursuant to Supreme Court Rule 29.6, Respondent

Align Technology, Inc. (Align) avers that it has no parent

corporation, and no publicly-held company holds more

than ten percent of Align’s stock.

iil

TABLE OF CONTENTS

QUESTIONS PRESENTED .................

CORPORATE DISCLOSURE STATEMENT ..

REIEEAE SEURET EGE: ioe a sce ksodventeunts

TABLE OF CITED AUTHORITIES ..........

Bap eS Sy g | | GC ey een re rae

STATUTORY PROVISIONS INVOLVED .....

STATEMENT OF THE CASE ...............

REASONS FOR DENYING THE PETITION

I. Ormeco’s Case Does Not Warrant Further

PR oh iain kk eel iin

A. Courts Are Not Just Permitted, They

Are Required, To Consult The

Specification In Construing Patent

RE cua kee chucevee eins cures

B. Ormco Conceded On Appeal That

The ‘562 Prosecution History Was

Relevant To The Interpretation Of At

Least Some Of The Asserted Claims

Page

iii

iv

Contents

Page

C. The Public-Notice Function Of A

Patent Is Not Impaired By The

Incorporation of Disavowals From the

Specification or Disclaimers From the

Pros@cution History’. 6.6 cs cesces se 24

Il. Ormco Is Not Entitled To A Different

ee hee ee ere re ee rarer 27

III. Policy Considerations .................. 29

SEINE ok danse nu Wed cases conw ee es kanes 30

Vv

TABLE OF CITED AUTHORITIES

Page

Cases:

Astrazeneca AB v. Mutual Pharmaceutical Co.,

384 F.3d 1833 (Fed. Cir. 2004) ............... 25

Ballard Medical Products v. Allegiance

Healthcare Corp., 268 F.3d 1352 (Fed. Cir.

i ki ghee NG es been Kees 14

Computer Docking Station Corp. v. Dell, Inc.,

__ F3d. _, 2008 WL 752675 (Fed. Cir. Mar.

ee waa ae nade has 18

Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358

a na ale baw aan sees 18.

Hogg v. Emerson, 47 U.S. (6 How.) 487, 12 L. Ed.

is ew kw wate bs 17

Honeywell Intern., Inc. v. ITT Industries, Inc.,

452 F.3d 1312 (Fed. Cir. 2006) ............... 26

Hybritech, Inc. v. Monoclonal Antibodies, Inc.,

802 F.2d 1367 (Fed. Cir. 1986) ............... 9

In re Vaeck, 947 F.2d 488 (Fed. Cir. 1991) ...... 9

Inpro IT Licensing, S.A.R.L. v. T-Mobile USA,

Inc., 450 F.3d 1350 (Fed. Cir. 2006) .......... 26

vi

Cited Authorities

Page

Jonsson v. Stanley Works, 903 F.2d 812 (Fed. Cir.

aie ie i bend veueyuhal ew cednaaee 23

Kinik Co. v. Int'l Trade Comm’n, 362 F.3d 1359

SE IIE nn ccccccacsvccdaccsesseades 17, 22

Markman v. Westview Instruments, Inc.,

52 F.3d 967 (Fed. Cir. 1995) (en banc) ........ 13, 17

Merck & Co. v. Teva Pharms. USA, Inc.,

347 F.3d 1367 (Fed. Cir. 2003) ............... 17

Metabolite Labs., Inc. v. Lab. Corp. of Am.

Holdings, 370 F.3d 1354 (Fed. Cir. 2004) ..... 17

Mitchell v. Tilghman, 86 U.S. 287 (1873) ...... 9

Moba, B.V. v. Diamond Automation, Inc., 325

Fd 1006 (red. Cir. 2008) .............05%.. 17

Netword, LLC v. Centraal Corp., 242 F.3d 1347

ss a Gk dae na ee he's 16, 18-19

Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314

ED 6 os news kb ab des ca kawed bows 23

Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir.

I TACT CUE Kai phen tcokkarews 16, 17, 19, 24

vil

Cited Authorities

Page

Renishaw PLC v. Societa’ per Azioni, 158 F.3d

SC ROOD cis bv ddn se csawe thaeeae ~ 39

Schriber-Schroth Co. v. Cleveland Trust Co. , 311

AEE Coda wnned Pen scdWavs ned aaeese 16-17

SciMed Life Sys., Inc. v. Advanced Cardiovasculary

Sys., Inc., 242 F.3d 1337 (Fed. Cir. 2001) ..... 25

Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d

I SO EE 5 ur cc Kc dbw wba nesncades 17, 19

Ventana Medical Sys. v. Biogenex Labs., 473 F.3d

DE each os ce dbs tk ha awe ce 19, 20, 22, 28

Vitronics Corp. v. Conceptronic, Inc., 90 F.3d

oF a | ee er Pr rrr 18

Statutes:

SE BO ohana da ck sn avehenskaeveeneeus 1,16

1

JURISDICTION

The district court was empowered to adjudicate the

parties’ respective claims and counterclaims for patent

infringement under 28 U.S.C. §§ 1331 and 1338(a). The

United States Court of Appeals for the Federal Circuit

had jurisdiction over the ensuing appeal and cross-appeal

under 28 U.S.C. § 1292(c). This Court’s jurisdiction is

invoked under 28 U.S.C. § 1254(1).

STATUTORY PROVISIONS INVOLVED

In aid of its untenable argument that patent claims

ought not be read in light of the specification, of which

they are a part, Ormco Corporation (Ormco) omitted

from its petition for certiorari the statutory language

(in bold type below) that immediately precedes the

language it selectively quoted from 35 U.S.C. § 112:

§ 112. Specification

The specification shall contain a written

description of the invention, and of the

manner and process of making and using

it, in such full, clear, concise, and exact

terms as to enable any person skilled in the

art to which it pertains . .. to make and use

the same, and shall set forth the best mode

contemplated by the inventor of carrying

out his invention.

The specification shall conclude with one or

more claims particularly pointing out and

distinctly claiming the subject matter which

the applicant regards as his invention....

2

STATEMENT OF THE CASE

In 2003, Ormco Corporation sued Align Technology,

Inc. (Align) for infringement of four related patents

all directed to the computer-executed design

and manufacture of conventional wire-and-bracket

appliances to move teeth, 2.e¢., “braces.” In arguing for

allowance of the first patent in this family (U.S. Patent

No. 5,431,562 or “the ‘562 patent”) in the early 1990s,

Ormco emphatically distinguished its invention from

still-earlier inventions that had applied traditional

computer-aided-design (CAD) techniques to designing

orthodontic appliances. The traditional techniques,

Ormco asserted, merely helped the orthodontist to

“model” a desired result by enabling her to manipulate

digital images of a patient’s teeth into an arrangement

the orthodontist deemed optimal. The groundbreaking

feature of its invention, Ormco claimed, was the virtual

independence from fallible human judgment in the

design of orthodontic appliances. Specifically, Ormco

claimed to have devised a series of reliable algorithms

that a computer could execute, following a simple data-

input procedure, to arrive at the optimal final

arrangement for any given patient’s teeth.

Years after Ormco filed the application leading to

the ‘562 patent—to which each of the asserted patents

claims priority'—Align developed the Invisalign®

1. A patent applicant claims a distinct benefit by filing

continuation patents that relate back to an earlier “ancestor”

patent, as Ormco did here: the continuation patents are accorded

(Cont'd)

3

System, a completely novel approach to straightening

teeth.” In applying for the most recent

of the continuation patents it asserted against Align

(U.S. Patent No. 6,616,444 or “the ‘444 patent”), almost

ten years after prosecuting the application that issued

as the ‘562 patent, Ormco wrote markedly broader and

more ambiguous claims in a plain attempt to make its

earlier invention read on Align’s product. By broadening

the claims, however, Ormco improperly attempted to

recapture subject matter that the patent applicants

had expressly disavowed in both the asserted patents’

common specification and in the arguments they had

made to the Patent Office to win issuance of the ‘562

patent, the “parent” to all four of the asserted patents,

which shares the same specification.

(Cont'd)

the same “priority date,” 2.e., they are deemed to have been filed

on the date the “ancestor” application was filed. Inventions

claimed in continuation patents are thus deemed to have

preceded any otherwise-invalidating prior art that came into

existence between the filing dates of the ancestor and the

continuation applications.

2. Align’s product and manufacturing process, unlike

Ormco’s patented process, is not fully automated, but rather

relies upon skilled human operators to manipulate digital images

and to make decisions about where and how a patient’s teeth

should move. In addition, Align’s Invisalign® appliances are

worn by the user for prescribed intervals, not affixed to the teeth,

and are made of clear polymeric material, not wire and brackets.

Further, Ormco’s patents teach the manufacture of a single ideal

appliance, whereas the Invisalign® System is comprised of a

number of separate appliances used sequentially.

4

Disparaging Statements In The Asserted Patents’

Common Specification

Each of the four* patents-in-suit shares a common

specification—which Ormco inexplicably omitted from

the Appendix to its Petition—which begins by explaining

that:

[a] problem of the prior art that has inhibited

the selection or design of an ideal orthodontic

appliance for the patient is the difficulty in

arriving at an expression of the ideal finish

position of the teeth. Orthodontists typicalty—

make models.of the patient’s mouth, and, with

the models and the aid of x-rays, determine a

treatment to move the teeth to finish tooth

positions. This process is time consuming and

presents a source of error and inaccuracy.

From the measurements and based on the

judgment of the orthodontist, appliance

components are selected to implement the

prescribed treatment. In reality, the treatment

of patients is in many cases more of an art than

a science, with results ranging from poor to

excellent, and generally variable.

Supp. App. 57-58 (‘444 patent col.2 1.64-col.3 1.10).

3. The Federal Circuit affirmed the district court’s

judgment as to three of the four asserted patents. It reversed

and remanded as to select claims from the ‘444 patent.

5

The problem, according to the applicants, was the

prior art’s unavoidable reliance on human judgment,

owing to the difficulty of “developing an automated

system that includes reliable and efficient decision

making algorithms and techniques for automatically

determining an ideal finish position of the teeth.” Supp.

App. 58 (‘444 patent col. 3 11.17-22). Thus, the stated

“primary objective of the present invention” was to

provide “... a practical, reliable and efficient custom

appliance automated design and manufacturing system

and methods of automatically designing custom

orthodontic appliances and treating patients therewith.”

Supp. App. 58 (‘444 patent coal.3 11.41-45). The

specification continues: “In accerdance with the

preferred embodiment of the preser® invention, there

is provided a computerized system and method with

which finish positions of the teeth of a patient are derived

from digitized information of anatomical shapes of the

patient’s mouth. . .” Supp. App. 58 (444 patent col.4 11.16-

20). “The computer ... at the appliance facility ...

calculates, based on the digitized information..., the final

position of the patient’s teeth. ...” Supp. App. 63 (‘444

patent col.14 11.6-8). The patents go on to recite the

detailed formulas and algorithms the computer applies

in order to arrive at this determination. Supp. App. 76-

83 (‘444 patent. col. 39 1.41-col. 53 1.52). Following the

disclosure of these formulas is the statement: “[a]t this

point, the final positions of the maxillary teeth have been

calculated, and thus, the finish positions of all of the

teeth.” Supp. App. 83 (‘444 patent col. 53 11.50-52). As

the Federal Circuit noted, “[t]here is no discussion of

operator or orthodontist review or adjustment of those

6

finish positions or of the bases on which such review and

adjustment might be made.” Pet. App. 10a.

Distinguishing Statements Applicants Made to

Secure Allowance of the Parent Patent

As the Federal Circuit determined, the narrow scope

of Ormco’s claimed inventions was firmly established by

definitive statements the applicants had made to the

Patent Office to obtain issuance of the ‘562 patent, the

parent to all four of the patents Ormco asserted against

Align. The applicants secured allowance of the ‘562

patent—which shares the same specification as the

asserted patents, and to which each of the asserted

patents claims priority—through the same combination

of disparagement (of the human-involved methods and

uncertain results of the prior art) and rhapsody (over

the invention’s promise of better-aligned teeth through

computer-executed math). Originally, the Patent

Examiner rejected the claims of the ‘562 application for

obviousness, citing a still-earlier patent (U.S. Patent No.

5,011,405 or “the ‘405 Patent”), which also claimed a

computerized method for designing orthodontic

appliances, issued to one Dr. Marc S. Lemchen. In their

Response, the applicants overcame the Examiner’s

rejection by making a number of statements

characterizing the Lemchen patent and explaining in

very broad terms why their invention was different, and

better:

Using such a CAD [computer-aided design]

program in a conventional manner, as

Lemchen describes, an operator would

7

manipulate the tooth images to provide the

desired occlusion. This would presumably

involve some decision making by the operator.

As the operator manipulates the images,

the computer, under the control of the

conventional CAD program, would perform

calculations that would generate data of the

tooth movements made by the operator and

thus of the finish positions of the teeth. ...The

Lemchen patent relies, to produce the

calculations, on the conventional calculation

techniques employed in generalized CAD

software. This in turn relies on a user

interactive interface by which an operator

contributes human decision making powers

to manipulate images until the operator is

satisfied that finish tooth position criteria

have been met... . [W]Jith conventional CAD

programs, the reliance on human decision

making is heavy, and rigorous fully

automated arrival at tooth finish positions is

lacking.

March 16, 1994, Response to Office Action, p. 49, JA 1323-

1324 (emphasis added).

The applicants go on to distinguish their own

invention in similarly broad terms:

The present invention of applicants is directed

toward the most complete and fully automated

method for orthodontic appliance design and

manufacture made.... The judgment, or

8

decision making, on the acceptability of tooth

positions must be imposed externally of

Lemchen’s system. This leads to human error

and inconsistencies from patient to patient.

Lemchen does not disclose this being done

automatically thereby avoiding such errors

and inconsistencies. ... Therefore, Lemchen

... uses a user interactive computer system

to calculate tooth finish positions, [whereas]

applicants have provided a computerized

system with the intelligence to decide for itself

the best finish positions of the teeth.

Id., JA 1326-1831.

In further support of these arguments to the

Examiner to allow the ‘562 Patent, Ormco submitted a

Declaration from Dr. Michael W. Scott, an orthodontist,

which states: “In applicants’ overall method, it is a

computer, not an orthodontist or an orthodontically

skilled computer operator that makes the decision on

the finish positions in which the teeth are to be placed.”

March 16, 1994 Supp. Decl. of Scott, pp. 9-10, JA 1378-

1379. These statements leave no doubt that the

applicants defined Ormco’s claimed inventions as

excluding manual or human-interactive- as opposed to

automated — design of orthodontic appliances.

Align’s Summary Judgment Motions

The public record, including the ‘562 prosecution

history and the asserted patents’ common specification,

establish that Ormco’s patented invention is narrow.

Accordingly, Align moved the district court for summary

9

judgment of non-infringement. First, Align argued that

the asserted patent claims were necessarily limited to

intelligent and automated computer systems for

designing and manufacturing orthodontic appliances.

The district court agreed. Then, since it was undisputed

that Align’s accused design and manufacturing processes

are informed by the judgments of trained operators or

orthodontic practitioners,‘ the district court granted

Align’s motion for summary judgment of non-

infringement as to every asserted claim. Next, Align

moved for summary judgment that the Ormco patents

were invalid as not enabled’ since, after eleven years of

diligent effort, Ormco itself had not succeeded in making

a working system as intelligent as that the patents

describe and claim. Applying the same claim

construction, the district court granted this motion, and

invalidated the asserted claims for nonenablement.

4. Align currently employs more than 500 such trained

operators.

5. “(I]t is settled law that a patent is void if the described result

cannot be obtained by the described means.” Mitchell v. Tilghman,

86 U.S. 287, 396 (1873), overruled on other grounds. “Enablement

requires that the specification teach those in the art to make and

use the invention without ‘undue experimentation.” Jn re Vaeck,

947 F.2d 488, 495 (Fed. Cir. 1991). Those of ordinary skill in the art

must be able to make and use the invention “as broadly as it is

claimed.” Jd. at 496. Enablement is a legal question based on

underlying factual inquiries, and is determined as of the filing date

of the patent application. Hybritech, Inc. v. Monoclonal Antibodies,

Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986).

10

Ormco’s Appeal

On appeal, Ormco argued that the district court had

defined Ormco’s patent rights “without reference to” the

asserted claims. Ormco conceded that in construing the

claims the district court was entitled to consider the

specification as well as the applicants’ statements, such as

those quoted above, from the ‘562 patent’s prosecution

history. Bl.Br. 42. Ormco asserted, however, that the district

court had applied those statements too broadly. In

particular, Ormco said the statements from the ‘562

prosecution history should have been permitted to inform

the interpretation of only those patent claims that featured

“linking language” inviting reference to those statements.

In its opening brief on appeal, Ormco specifically called

out claims 37-40, 45 and 69 of the ‘444 patent as not featuring

such language. “Those claims,” Ormco explained, “are

directed to methods of processing digital data about the

teeth, not to determining finish tooth positions.” B1.Br. 35.

What is odd about Ormco’s present petition is that

Ormco prevailed on appeal as to its principal argument.

The Federal Circuit, with resort to the full record and

applying overlaid de novo standards of review—first to the

district court’s claim construction and second to the district

court’s summary-judgment determinations—affirmed-in-

part and reversed-in-part. And it did so on the very basis

Ormco argued. The Court of Appeals, in fact, reversed and

remanded the judgment as to the very claims Ormco itself

had identified as having no “linking language” because the

Court agreed those claims lacked any such language

inviting reference to the narrowing statements that

appeared in the specification or ‘562 file history.

11

The Court held that claim terms could be interpreted

by reference to statements in the prosecution history of

a related patent if there was language in the claims

confirming their relation to the subject matter of those

statements. Pet. App. lla. Thus, the Court affirmed the

judgment only as to those claims directly related to

determining finish tooth positions, the subject matter

of the multiple statements quoted above from the

specification and the ‘562 prosecution history. In doing

so, it specifically cited the claim language it found to be

“linking.” Pet. App. 14a. It reversed as to the very claims

Ormco distinguished in its opening brief because, as

Ormco had pointed out, those claims related to other

subject matter, 2.e., “the preliminary gathering and

organization of tooth data... .” Pet. App. 16a. In other

words, the Federal Circuit did exactly what Ormco asked

it to do: it affirmed only as to the claims whose language

directly “linked” them to the inventors’ disclaiming

statements, and it reversed as to the rest. Ormco is

dissatisfied simply because the Federal Circuit, in

applying this argument, found “linking language” in

more claims than Ormco did.

Ormco’s petition for rehearing was denied.

12

REASONS FOR DENYING THE PETITION

Ormco cannot articulate a question worthy of this

Court’s review without soft-pedaling the law and the

facts that are dispositive of this case. In its bid to

persuade the Court that Congress intended patent

claims to be construed in a vacuum, Ormco asserts that

only one sentence of the Patent Act, defining claims, is

“relevant” to understanding the issues presented here.

But the entire paragraph that precedes that sentence in

the statute defines the patent specification, of which the

claims are the final part. In similar fashion, Ormco

supplies the Court with the bare language of its asserted

patent claims, but withholds the 100 pages of text and

drawings (the written description portion of the

specification) that give meaning to those claims. In its

petition, Ormco declines even to quote the statements it

insists the lower courts misconstrued, and, needless to

say, it offers no alternative explanation whatsoever for

those statements.

Moreover, Ormco denies the obvious fact that the

Court of Appeals did consider the text of Ormco’s patent

claims both in reversing, in Ormco’s favor, with respect

to certain claims, and affirming with respect to the rest.

Not only that, the Court specifically recited the claim

language that impelled its decision. The text of the claims

was clearly not disregarded.

Finally, Ormco shrinks from saying outright that the

remand it seeks would merely serve to require the

district court to reconsider a decision the Court of

Appeals has already affirmed-in-part and reversed-in-

part upon de novo review of the same evidence and

13

argument the parties presented to the district court — relief

that would cost the parties and the courts much time and

effort — without likely yielding a different result.

Ormco is plainly unhappy with the Federal Circuit’s

judgment holding the majority of the patent claims it

asserted against Align to be not infringed and not valid.

But this is hardly evidence of the Federal Circuit’s

disregard for this Court’s or Congress’s authority, as Ormco

suggests. In fact, it is Ormco that refuses to acknowledge

the true significance this Court and Congress have

accorded to the patent specification in construing patent

claims, which are quite different from laws or statutes.

Whereas the Court has shown a preference for construing

statutes according to their plain meaning without resort to

legislative history, it has shown no hesitation about

ascertaining the meaning of a patent’s claims, which are

part of its specification, by consulting other parts of its

specification. To the contrary, this Court has long held that

a patent’s claims are always to be read in light of its

specification. And the Federal Circuit has confirmed that

the specification, the prosecution history, and the claims

together constitute the intrinsic record, which district

courts must consult, in determining the meaning of patent

claims. Both this Court and the Federal Circuit have

consistently held that it is the properly construed claims

(interpreted in view of the intrinsic record) that define the

boundaries of the invention. There is no controversy here.

Ormco has described a mild insult to the process it

believes it was due: the district court did not hold a formal

claim-construction hearing. But, as Ormco knows, the law

does not require such a hearing. In fact, Markman v.

Westview Instruments, Inc., 52 F-3d 967, 981 (Fed. Cir. 1995)

14

(en banc), clearly indicates that district courts have the

discretion to construe patent claims according to any

procedure they deem helpful.* In any event, the Court of

Appeals reviewed the district court’s claim construction

de novo in view of all the evidence the parties submitted,

and ultimately reversed and remanded select claims to

be construed anew in the district court.’ Any possible

6. As the Federal Circuit explained in Ballard Medical

Products v. Allegiance Healthcare Corp., 268 F.3d 1352, 1358 (Fed.

Cir. 2001):

Markman does not require a district court to follow

any particular procedure in conducting claim

construction. It merely holds that claim construction is

the province of the court, not a jury. To perform that

task, some courts have found it useful to hold hearings

and issue orders comprehensively construing the claims

in issue. Such a procedure is not always necessary,

however. If the district court considers one issue to be

dispositive, the court may cut to the heart of the matter

and need not exhaustively discuss all the other issues

presented by the parties. District courts have wide

latitude in how they conduct the proceedings before

them, and there is nothing unique about claim

construction that requires the court to proceed

according to any particular protocol. As long as the trial

court construes the claims to the extent necessary to

determine whether the accused device infringes, the

court may approach the task in any way that it deems

best.

7. Ormco has taken the position on remand that a claim

construction hearing is unnecessary. Joint Status Report of the

Parties filed in United States District Court, Central District of

California on March 20, 2008, p. 3. Align is completely in

the dark as to what advantage Ormco expects to secure by

simultaneously making diametrically-opposed arguments to two

different federal courts.

15

procedural slight to Ormco was thus obliterated. Ormco

never once suggests that it could or should have won

this case on the merits. Having described no procedural

and no substantive injury, Ormco has shown no cause to

grant the writ.

I. Ormco’s Case Does Not Warrant Further Hearing

This Court need not even review the record to

confirm that Ormco’s chief complaints about the Federal

Circuit are false. Since the law does not permit Ormco

to argue that it was entitled to a detailed, limitation-by-

limitation construction of each of the 92 claims *+ asserted

against Align, Ormco says the Court o. Appeals

construed the claims without consulting their text, and

without reciting the language the Court viewed as

inviting reference to the disavowals and disclaimers

appearing in the ‘562 prosecution history and the patents’

common specification. But Ormco can only make this

claim by ignoring the crux of the Federal Circuit’s

opinion. In distinguishing among the patent claims whose

scope was limited by Ormco’s own prior statements, and

thus required automation, and those whose scope was

not so limited, the Court of Appeals certainly examined

and interpreted the individual asserted claims. In fact,

it cited, and quoted the “linking language” from,

numerous claims to illustrate how they related to the

subject matter of the prior statements. Pet. App. 14a-

17a. There is no other conceivable basis for its partial

reversal, and Ormco suggests none.

16

A. Courts Are Not Just Permitted, They Are

Required, To Consult The Specification In

_ Construing Patent Claims

The law simply provides no traction for Ormco’s

argument that it was entitled to a claim interpretation

uninformed by the lower courts’ review of the patents’

common specification. (Similarly misguided is Ormco’s

attempt to deliver this Court from that temptation by

excluding the written description of its invention from

its Appendix altogether.) There is no conflict in the law

on this point. This Court and the Federal Circuit have

always encouraged district courts to consider the

specification when interpreting patent claim language.

Phillips v. AWH Corp., 415 F.3d 1303, 1315-1316 (Fed.

Cir. 2005) (en banc) (practice of referring to specification

for claim interpretation has “a long pedigree in Supreme

Court decisions” dating as far back as 1848). “The claims

of a patent are always to be read or interpreted in light

of its specifications.” * Schriber-Schroth Co. v. Cleveland

8. The importance of the specification in claim

construction derives from its statutory role [of

which Ormeo also would keep this Court

ignorant]. The close kinship between the

written description and the claims is enforced

by the statutory requirement that the

specification describe the claimed invention in

‘full, clear, concise, and exact terms.’ 35 U.S.C.

§ 112, para. 1; see Netword, LLC v. Centraal

Corp., 242 F.3d 1347, 1352 (Fed. Cir. 2001) (“The

claims are directed to the invention that is

described in the specification; they do not have

meaning removed from the context from which

(Cont'd)

17

Trust Co., 311 U.S. 211, 217 (1940); Hogg v. Emerson, 47

U.S. (6 How.) 437, 482, 12 L.Ed. 505 (1848) (the

specification is a “component part of the patent” and “is

as much to be considered with the [letters patent] in

construing them, as any paper referred to in a deed or

other contract.”). “The descriptive part of the

specification aids in ascertaining the scope and meaning

of the claims inasmuch as the words of the claims must

be based on the description. The specification is, thus,

the primary basis for construing the claims.” Standard

Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 452 (Fed.

Cir. 1985); Metabolite Labs., Inc. v. Lab. Corp. of Am.

Holdings, 370 F:3d 1354, 1360 (Fed. Cir. 2004) (“In most

cases, the best source for discerning the proper context

of claim terms is the patent specification wherein the

patent applicant describes the invention.”); see also, e.g.,

Kinik Co. v. Int'l Trade Comm’n, 362 F.3d 1359, 1365

(Fed. Cir. 2004) (“The words of patent claims have the

meaning and scope with which they are used in the

specification and the prosecution history.”); Moba, B.V.

v. Diamond Automation, Inc., 325 F.3d 1306, 1315 (Fed.

Cir. 2003) (“[T]he best indicator of claim meaning is its

usage in context as understood by one of skill in the art

at the time of invention.”); Merck & Co. v. Teva Pharms.

USA, Inc., 347 F.3d 1367, 1371 (Fed. Cir. 2003)

(“A fundamental rule of claim construction is that terms

in a patent document are construed with the meaning

(Cont'd)

they arose.”); see also Markman v. Westview

Instruments, Inc.,517 U.S. 370, 389 (1996) (“[A

claim] term can be defined only in a way that

comports with the instrument as a whole.”)

Phillips, 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en banc).

18

with which they are presented in the patent document.

Thus claims must be construed so as to be consistent

with the specification, of which they are a part.”)

(citations omitted).”)

Equally weightless is Ormco’s complaint that the

lower courts turned to the written description portion

of the specification prematurely, before they had

attempted to construe the claims in a vacuum. That

patent claims are assigned primacy under the law does

not limit the courts’ authority simultaneously to examine

other evidence of their meaning. In fact, courts

construing patent claims “must” review the intrinsic

evidence—consisting of the claim language, the

specification, and the prosecution history—in its totality.

Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358, 1366

(Fed. Cir. 2001) (emphasis added); see also Computer

Docking Station Corp. v. Dell, Inc., _F.3d.__, 2008 WL

752675, *4 (Fed. Cir. Mar. 21, 2008) (“It is well-settled

that, in interpreting an asserted claim, the court should

look first to the intrinsic evidence of record, 2.e., the

patent itself, including the claims, the specification and,

if in evidence, the prosecution history.”), quoting

Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582

(Fed. Cir. 1996).

The written description portion of the specification,

which precedes the claims—and which, in the case of

the ‘444 patent, comprises some 100 pages of text and

drawings—is what provides the “full, clear, concise, and

exact” description of the invention required by statute.

This description precedes the claims in every patent, and

gives them meaning. “(T]hey do not have meaning

removed from th{is] context ...” Netword, 242 F.3d at

19

1352; Standard Oil Co. 774 F.2d at 452 (because claims

are “based on the [written] description, ... [t]he

specification is ... the primary basis for construing

the[m].”)

Even the sequence of this presentation (specification

concluding with claims) signals that the descriptive text

and drawings provide the backdrop against which the

claims are interpreted. “The claims [do not] enlarge what

is patented beyond what the inventor has described as

the invention.” Netword, 242 F.3d at 1352. Thus, the

Federal Circuit has held, “(t]he construction that stays

true to the claim language and most naturally aligns with

the patent’s description of the invention will be, in the

end, the correct construction.” Phillips, 415 F.3d at 1316

(quoting Renishaw PLC v. Societa’ per Azioni, 158 F.3d

1243, 1250 (Fed. Cir. 1998)). This holding is perfectly

consistent with Congress’s and this Court’s own

pronouncements.

To be sure, courts must take pains not to import into

the patent claims as limitations language that is merely

intended to characterize a particular disclosed

embodiment of the invention, or to read as disavowals

general statements appearing in the specification

“indicating that the invention is intended to improve

upon [the] prior art. ...” Ventana Medical Sys. v.

Biogenex Labs., 473 F.3d 1178, 1181. But Ormco does

not even suggest that either of those things happened

here. Nor could it.

The present case is in perfect accord with Ventana,

which holds that claim terms are to be given their

ordinary and customary meaning “unless something in

_—_————. SSS

20

the specification or prosecution history reflected the

inventor’s intent that one of ordinary skill should

interpret the claim terms differently.” Cert. Pet. 18

(emphasis added). This case illustrates that exception.

When Ormco attempted to broaden its patent claims,

with the filing of the application leading to. the ‘444

patent, the claims got farther afield from the description

provided in the specification. That description could not

be altered, however, without jeopardizing the later

patent’s claim of priority to the ancestor ‘562 patent.

Thus, while, without reviewing the intrinsic record, the

‘444 patent claims appear broad enough to capture a

human-driven design process, the written description

makes abundant!y clear that Ormco long ago disavowed

such a process.

In Ventana, the defendant argued that statements

in the specification describing the invention’s general

improvement over the prior art worked as a blanket

disavowal of all the described prior art. The Federal

Circuit rejected this conclusion, observing first that, if

it were correct, then the inventors would have disavowed

coverage of a method employed by the patent’s preferred

embodiment. Here, there is no conflict between what the

applicants clearly disavowed and what they plainly

claimed.

In addition, the Court in Ventana held that such

general statements as the inventors made could not be

interpreted to disclaim every feature of every prior art

device discussed in the patent. /d., 473 F.3d at 1181. Here,

the specification does not merely announce a general

advance past the prior art, as did the specification at

issue in Ventana. Id., 473 F.3d at 1181. It expressly

21

disparages the prior art’s approach to “arriving at an

expression of the ideal finish position of the teeth,” 2.e.,

an orthodontist manipulating (digital or solid) models of

the patient’s teeth, as “present[ing] a source of error

and inaccuracy.” Supp. App. 58 (‘444 patent col.3 1.4). It

attributes the “variable” results of the prior art to the

difficulty of “developing an automated system that

includes reliable and efficient decision making

algorithms and techniques for automatically determining

an ideal finish position of the teeth.” Supp. App. 58. (‘444

patent col.3 ll. 19-22). It announces “a computerized

system and method with which finish positions of the

teeth of a patient are derived from digitized information

of anatomical shapes of the patient’s mouth” (Supp. App.

58 (444 patent col.4 11.17-21)) by a “computer [which]

... calculates, based on the digitized information . . . the

final position of the patient’s teeth.” Supp. App. 63 (444

patent col.14 11.6-8). And it goes on to describe a simple

data-input procedure, Supp. App. 72-76 (‘444 patent

col.32 1.65-col.39 1.39), followed by a lengthy series of

algorithms for a computer to execute in order to discover

an optimal final tooth arrangement, Supp. App. 76-83

(‘444 patent col.39 1.41-col.53 1. 54).

As important, the specification does not describe how

an orthodontist exerting her own judgment might go

about deciding a final tooth arrangement for herself. It

does not even describe how she might perfect or “tweak”

the computer’s final judgment once the computer has

completed the math. The specification, thus, does not

even purport to enable a process for determining final

tooth positions that is manual or utilizes human decision

making. It does not support any interpretation for the

asserted claims other than the one reached by the

22

Federal Circuit. See Kinik Co. v. Int'l Trade Comm’n,

362 F.3d at 1365 (“The words of patent claims have the

meaning and scope with which they are used in the

specification and the prosecution history.”)

Ventana further holds that “when [a] claim

addresses only some of the features disclosed in the

specification, it is improper to limit the claim to other,

unclaimed features.” Ventana, 473 F.3d at 1181. This is

precisely the basis upon which the Federal Circuit in this

case reversed the district court’s judgment to the extent

it did. It determined that the district court had

improperly limited certain claims as to features they did

not address.

Finally, in Ventana, rejecting defendant’s

prosecution-disclaimer argument, the Federal Circuit

explained that “the inventors did not rely on [the

allegedly-disclaimed feature] as a distinction between

the claims at issue in this case and the prior art.”

Id., 473 F.3d at 1188. Here, in contrast, that feature,

computer-executed versus human-dictated design, is

precisely the basis upon which the inventors

distinguished their patent claims and the prior art.

Simply put, the Federal Circuit followed Ventana and

other consistent, well-settled claim construction

principles in construing Ormco’s patent claims. There

is no conflict.

23

B. Ormco Conceded On Appeal That The ‘562

Prosecution History Was Relevant To The

Interpretation Of At Least Some Of The

Asserted Claims

Patents in the same family ought to be read

consistently with one another, particularly when they

share the same specification. “Prosecution disclaimer

may [thus] arise from disavowals made during the

prosecution of ancestor patent applications.” Omega

Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1333 (Fed.

Cir. 2003); Jonsson v. Stanley Works, 903 F.2d 812, 818

(Fed. Cir. 1990). Ormco has admitted that this principle

is appropriately applied under certain circumstances.

Here, Ormco conceded on appeal that “[t]he

statements from the ‘562 prosecution history cited by

the district court are relevant ... to the limitation of

deriving tooth finish positions from a derived ideal dental

archform.” B1.Br. 42. Thus, the gist of Ormco’s argument

on appeal was not that the claims should be construed in

a vacuum, but rather that “Federal Circuit law require[d]

a link between the claim language at issue in the

prosecution history and the language being construed.”

B1.Br. 40 (emphasis added).

The Federal Circuit found such a link. Here, the

sweeping and specific disclaimers the applicants made

to the Patent Office to secure issuance of the ‘562 patent

were perfectly in keeping with the statements they made

in the asserted patents’ common specification. Moreover,

as the Federal Circuit noted, “[nJone of the prior

statements ... were limited to particular claims.”

Pet. App. 13a. The Federal Circuit nonetheless agreed

24

with Ormco that “linking language” (or a “linguistic

hook”) was required to “pull in” the disclaimers the

applicants made in prosecuting the parent patent to the

interpretation of the offspring patents. But, upon

examining the text of the 92 asserted claims, the Court

of Appeals determined the majority featured such

language. As to the rest, the Court reversed. Ormco’s

only conceivable complaint is that it does not agree with

the decision the Federal Circuit reached after applying

the analysis Ormco urged. But mere disagreement with

the result is not a proper basis for this Court’s review.

C. The Public-Notice Function Of A Patent Is

Not Impaired By The Incorporation of

Disavowals From the Specification or

Disclaimers From the Prosecution History

Ormco suggests the lower courts have impaired the

public-notice function of its patent claims by reading

obscure limitations from the specification and an

unrelated prosecution history into the claims. But this

assessment is unsupportable. First, the customary and

ordinary meaning of claim terms is “the meaning that

the term would have to a person of ordinary skill in the

art in question at the time of the invention.” Phillips,

415 F.3d at 1313. And that person “is deemed to read the

claim term not only in the context of the particular claim

in which the disputed term appears, but in the context

of the entire patent....” Jd. Thus, the public notice

function can only be served by consideration of the

claims, the specification and the prosecution history

together — not the claims in isolation.

25

Second, there was nothing obscure about Ormco’s

claim to have invented “... a practical, reliable and

efficient custom [orthodontic] appliance automated

design and manufacturing system.” Supp. App. 58 (‘444

patent col.3 1l.42-43). Neither was there anything obscure

about Ormco’s disdain for the traditional approach to

orthodontic treatment “based on the judgment of the

orthodontist” (Supp. App. 58 (‘444 patent col.3 11.5-6)),

which, Ormco asserted, was “more of an art than a

science, with results ranging from poor to excellent, and

generally variable.” Supp. App. 58 (‘444 patent col.3 Il.

9-10). Placing such pronouncements on the face of a

patent is a classic way to disown subject matter from an

invention. A skilled artisan reading the specification

would understand such a disavowal and would be placed

on notice of the narrow scope of the claims.

“[W Jhere the general summary or description of the

invention describes a feature of the invention ... and

criticizes other products. . . that lack that same feature,

this operates as a clear disavowal of these other products

(and processes using these products),” regardless of the

literal language of the claims. Astrazeneca AB v. Mutual

Pharmaceutical Co., 384 F.3d 18338, 13840 (Fed. Cir.

2004); see also SciMed Life Sys., Inc. v. Advanced

Cardiovascular Sys., Inc., 242 F.3d 1337, 1341 (Fed. Cir.

2001) (“Where the specification makes clear that the

invention does not include a particular feature, that

feature is deemed to be outside the reach of the claims

of the patent, even though the language of the claims,

read without reference to the specification, might be

considered broad enough to encompass the feature in

26

question.”); Honeywell Intern., Inc. v. ITT Industries,

Inc., 452 F.3d 1312, 1319 (Fed. Cir. 2006) (“It is true...

that the. . . patent’s written description did not expressly

define ‘electrically conductive fibers ... Nevertheless,

based on the disclosure in the written description, which

demeaned the properties of carbon fibers, we conclude

that the patentee thereby disavowed carbon fibers from

the scope of the [asserted] patent’s claims.”); Inpro II

Licensing, S.A.R. L. v. T-Mobile USA, Inc., 450 F.3d

1350, 1354 (Fed. Cir. 2006) (same).

Third, as noted above, the specification does not even

purport to enable a simpler method of arriving at ideal

finish tooth positions than the execution by a computer

of a series of algorithms. Automation is required, not

only because Ormco disavowed reliance on human

judgment, but also because the specification does not

even begin to describe, let alone in “full, clear, concise,

and exact terms,” how an orthodontist might make this

determination outside of an automated process.

Fourth, the public has full access not just to the

claims, but also to the specification and the prosecution

history of issued patents. Thus, contrary to Ormco’s

argument, the public would have been confused and

competition thwarted if the courts had read the claims

as Ormco urges without reference to this intrinsic

evidence, and accorded Ormco a bigger monopoly than

the one the Patent Office granted. Here, to the extent

there was a public-notice problem, it arose from Ormco’s

27

patent claims, which by themselves are inadequate to

put the public on notice as to the limited scope of the

patent grant. The Federal Circuit recognized and cured

this problem.

The situation here involves specifications that

in all respects tell us what the claims mean,-

buttressed by statements made during

prosecution in order to overcome a rejection

over prior art. .. . [T]o attribute to the claims

a meaning broader than any indicated in the

patents and their prosecution history would

be to ignore the totality of the facts of this case

and exalt slogans over real meaning.

Pet. App. 14a-15a.

II. Ormco Is Not Entitled To A Different Result

Ormco’s real complaint cannot be that the Federal

Circuit failed to look at its patent claims. The Federal

Circuit clearly did. Ormco’s real complaint may be in

the result—that, in reviewing Ormco’s patent claims, the

Federal Circuit found more “linking language” than

Ormco was willing to concede was there.

Ormco allowed that “[t]he statements from the ‘562

prosecution history [quoted above] are relevant” to

construing the asserted claims. B].Br. 42. But Ormco took

the position that the district court should have applied

the limitation called for by those statements—

automation—only to claims containing the specific

28

phrase, “deriving a dental arch form or ‘deriving’ finish

tooth positions,” because only that language appeared

in the statements quoted from the‘562 file history. B1.Br.

45. The Court of Appeals, however, found many other

synonymous concepts expressed in the claims at issue,

including “producing desired tooth position signals

containing digitized data of desired positions of a

plurality of the patient’s teeth”; “a computer

programmed. .. to calculate finish positions of the teeth

of the patient”; “determining treatment positions of the

teeth”; and “a computer programmed to apply at least

some automated tooth position criteria to produce a

digital model of the teeth of the scanned shapes in

desired positions.” Pet. App. 14a. These phrases, the

Court held, as well as those Ormco conceded, also invited

reference to the ‘562 file history. The Court thus

construed the claims featuring all of this language as

describing an automated process. In view of the facts

and legal precedents Ormco eschews, and even those

upon which it relies, the judgment is unassailable on the

merits. Indeed, Ormco has never even suggested a

plausible alternative construction for the 86 claims as to

which the Federal Circuit affirmed.

Moreover, as this case is fully consistent with the

majority decision in Ventana and the other decisions

Ormco cites, it poses no substantial conflict within the

Federal Circuit regarding the use of prosecution history.

Ormco simply does not like the result of the Court of

Appeals’ analysis with respect to the claims found to be

affected by the prosecution history.

29

III. Policy Considerations

Ormco suggests that, by affirming, the Federal

Circuit has invited any district court adjudicating a

patent case to avoid the claim-construction process by

simply divining the “essence of the invention” from the

specification. But this is untrue. The Federal Circuit did

not endorse a sweeping change in the law of claim

construction. The record supported affirmance in this

case, and the Court of Appeals saw no reason to remand

just to enforce its preference for a procedure the law

does not require:

We accept Ormco’s argument ... that the

district court failed to conduct a claim

construction in this case focusing on specific

claim language, is not lacking in force.

However, we review decisions, not opinions,

... and when we are able to fully comprehend

the specification, prosecution history, and the

claims and can determine that, to the extent

we have indicated, the district court arrived

at the correct conclusion, we need not exalt

form over substance and vacate what is

essentially a correct decision.

Pet. App. 18a.

Ormco’s petition for certiorari is an exhortation to

exalt form over substance. It makes no sense to require

the district court to conduct yet another inquiry into the

claims’ meaning (answering questions of law subject to

de novo review) when the Federal Circuit has already

affirmed the district court’s original claim construction

30

based on the complete appellate record. To require yet

another claim-construction process would increase the

litigation costs of both parties, waste precious court time

and set an expensive precedent in patent litigation, while

virtually assuring the same outcome. Ormco is unhappy

with the Federal Circuit’s decision. But this Court grants

review only when a party raises a specific, significant

and recurring legal error or a conflict in the law that

must be resolved. This case presents no such issue.

CONCLUSION

For all of the foregoing reasons, Ormco’s Petition

for a Writ of Certiorari should be denied.

DATED: April 7, 2008

Respectfully submitted,

DANIEL J. FuURNISS

Counsel of Record

ANNE M. RoGaskI

Nancy L. TOMPKINS

TOWNSEND AND TOWNSEND

AND CREW LLP

379 Lytton Avenue

Palo Alto, California 94301

(415) 326-2400

Counsel for Respondent

~Supplemental Brief Unavailable for Filming at this Time —