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

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Opposition Brief
- **Published:** January 1, 2007

## Text

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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

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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 —

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386010_0637%3A2. Public record. Not legal advice.