Petition for Writ of Certiorari — Neutrino Development Corp. v. Sonosite, Inc. (No. 06-1405)
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06140 5APR 1 9 2007
OFFICE OF THE CLERK
No. 06-
IN THE
Supreme Court of the United States
NEUTRINO DEVELOPMENT CORPORATION,
Petitioner,
v,
SONOSITE, INC.,
Respondent.
On PETITION FOR A WriT OF CERTIORARI TO THE
UnitTep STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT
PETITION FOR A WRIT OF CERTIORARI
Scotr D. MARRS
BEIRNE, MAYNARD & Parsons, L.L.P.
1300 Post Oak Boulevard
Suite 2500
Houston, Texas 77056
(713) 623-0887
Counsel for Petitioner
—
wor
208200 ce
COUNSEL PRESS
(800) 274-3321 + (800) 359-6859
i
QUESTIONS PRESENTED
When is a patent drawing alone adequate disclosure to
support a claim limitation so as to satisfy the written
description requirement of 35 U.S.C. § 112?
When is a patent drawing alone adequate disclosure to
support later amendments to the specification and claims so
as to avoid the “new matter” prohibition of 35 U.S.C. § 132?
ii
PARTIES TO THE PROCEEDING
Petitioner is Neutrino Development Corporation, a Texas ~
corporation.
Respondent is SonoSite, Inc., a Washington corporation.
Counterclaim Defendant, Richard Redano, was not a
party to the appeal to the United States Court of Appeals for
the Federal Circuit and is not a party to this Petition.
STATEMENT PURSUANT TO RULE 29.6
Petitioner, Neutrino Development Corporation, has no
parent corporations and no publicly held company owns more
that 10% of its stock.
ii
TABLE OF CONTENTS
Page
QUESTIONS PRESENTED ......ccccccceseeee i
PARTIES TO THE PROCEEDING AND RULE 29.6
CORPORATE DISCLOSURE STATEMENT ... ii
py i 8 ge ee Spr ena rere rere ili
TABLE OF CITED AUTHORITIES ............ Vv
TABLE OF APPENDICES .................4-. Vili
I. PETITION FOR A WRIT OF CERTIORARI .. ]
Il. OPINIONS AND ORDERS BELOW ........ |
ey PE vas Keats Par aineerces ti 2
BV. STATUTES INVOLVED occ cccucscercces 2
V. STATEMENT OF THE CASE .............. 3
ee 8 Oe eer Te ower er ree 3
I TOO on 6 Go Fira ee ee ee: 5
VI. REASONS FOR GRANTING THE
PUTRI i enc od ek beh eceeees 7
A. Binding Federal Circuit Law Is in Conflict
with Other Binding Federal Circuit Law ... 7
iv
Contents
Page
ie Li Lg ee ere 8
2. Neutrino’s Reliance upon Koito ...... 10
3. The Only Solution Is a Granting of the
i eRe CRE PORT Per O re Cre ee 11
B. This Court Should Settle the Issue of
Whether, and to What Extent, Patent
Drawings May Be Relied Upon .......... 13
ahs GRE, kc aren Ss ek ee ache ei 15
TABLE OF CITED AUTHORITIES
Page
Federal Cases
Hockerson-Halberstadt, Inc. v. Avia Group
International, Inc.,
222 FidG O91 (POG. Car, 20D) nc cc ccececwss 8-9, 11
Koito Manufacturing Co. v. Turn-Key-Tech, LLC,
301 F.3d 1142 (Ped. Cir. 2006) ........... 9, 10, 11
Markman vy. Westview Instruments, Inc.,
ee ee POU 65 bs iva cei eee hen eaves 12
Markman vy. Westview Instruments, Inc.,
ee en PF AWG als BPO) na ko es eseectasns 12
Neutrino Development Corp. v. SonoSite, Inc.,
337 F. Supp. 2d 942 (S.D. Tex. 2004) ......... 1,3
Neutrino Development Corp. v. SonoSite, Inc.,
410 F. Supp. 2d 529 (S.D. Tex. 2006 .......... ]
Neutrino Development Corp. v. SonoSite, Inc.,
423 F. Supp. 2d 673 (S.D. Tex. 2006 ......... 1, 6,9
Neutrino Development Corp. v. SonoSite, Inc.,
No. H-01-2484, 2007 WL 1040697
Ce Sc I BEE ov 0 eel Ci canes eens 2
Neutrino Development Corp. v. SonoSite, Inc.,
No. H-01-2484, 2007 WL 998636
Cs Ss Ns is AED a oc ic cveweecivvcets 2
vi
Cited Authorities
Page
Vas-Cath Inc. v. Mahurkar,
955 F.2e 1550 LPO, Ce, FSR ccc evenidvass 8
Wisniewski v. United States,
BaP es POT OE 4 shad reeds Shae SD Fy Oa Fe
Statutes _
Be A ease bedi eee ees 2
an 5 BA. BAT eee ere veruneee: 8
Pe OG Oe 8 iiss Ce eae ERS 3
Be Ars BBS oe RCN Coa een ee eee eee 3,8
Be Ns EE i Ske CE Ria wd ee Rewer 3
Pe Ge NE, hu ee eee ee ences kaye
Fe Aer BEE he cau hoor nine al Oebiee ken 14
Fe Re kek eens be ee oe es ee
Rule
Pe a PU Wy UL ED eek ease baae ers 12
vii
Cited Authorities
Page
Law Review Articles
Thomas W. Adams, The 1988 Revision of 28 U.S.C.
§ 1391(c): Corporate Venue Is Now Equivalent
to In Personam Jurisdiction Effects on Civil
Actions for Patent Infringement, 39 Clev. St.
1 TG SST See eh sh ietiveccereessia 7
vill
TABLE OF APPENDICES
Appendix A — Judgment Of The United States Court
Of Appeals For The Federal Circuit Dated And
epeee RPOMITIOE Gy QUO oe cece cc iecce pees
Appendix B — Memorandum And Order Of
The United States District Court For The Southern
District Of Texas, Houston Division Dated March
et Oe hehe pases ae eed ERK
Appendix C — Memorandum And Order Of The
United States District Court For The Southern
District Of Texas, Houston Division Dated
September 30, 2004 (Re: Plaintiff's Motion For
Summary Judgment On Infringement) .........
Appendix D — Memorandum And Order Of The
United States District Court For The Southern
District Of Texas, Houston Division Dated
September 30, 2004 (Re: Defendant’s Post-
Markman Motion For Summary Judgment) .....
Appendix E — Opinion Of The United States District
Court For The Southern District Of Texas,
Houston Division Dated January 23, 2006 .....
Appendix F — Memorandum And Order Of The
United States District Court For The Southern
District Of Texas, Houston Division Filed March
ea US ese ce eueweewses
ix
Appendices
Page
Appendix G — Order Of The United States District
Court For The Southern District Of Texas,
Houston Division Awarding Costs Dated March
PES oie C6h 4 6 ob Redan a oe eke eae 105a
Appendix H — Order Of The United States Court
Of Appeals For The Federal Circuit Denying
Petition For Rehearing Dated And Filed January
SOG MT tbo KUE LOREEN Kabat Reateebe eee 114a
Appendix I — Order Of The United States District
Court For The Southern District Of Texas,
Houston Division Dated August 20, 2003 ...... 116a
Appendix J — Relevant Statutes ............... 133a
1
I, PETITION FOR A WRIT OF CERTIORARI
Petitioner respectfully petitions for a writ of certiorari
to review the judgments of the Court of Appeals for the
Federal Circuit and of the United States District Court for
the Southern District of Texas.
II. OPINIONS AND ORDERS BELOW
The United States Court of Appeals for the Federal
Circuit did not render a written opinion, but instead, on
December 8, 2006, it affirmed the judgment of the lower
court through a judgment of affirmance pursuant to Rule 36
of the Federal Circuit Rules. This order, which is included
within Petitioner’s Appendix at la, may be found at 2006
WL 3780734. Similarly, the Federal Circuit, in denying the
request for « panel rehearing or rehearing en banc, did not
issue a written opinion, but delivered an order on January
19, 2007, which is included within Petitioner’s Appendix at
114a. The opinion of the United States District Court for the
Southern District of Texas, Neutrino Development Corp. v.
SonoSite, Inc., 423 F. Supp. 2d 673 (S.D. Tex. 2006) (3a), is
published, and it was issued on March 21, 2006.
Other published opinions of the United States District
Court for the Southern District of Texas are as follows:
Neutrino Development Corp. v. SonoSite, Inc., 410 F. Supp.
2d 529 (S.D. Tex. 2006) (46a); Neutrino Development Corp.
v. SonoSite, Inc., 337 F. Supp. 2d 942 (S.D. Tex. 2004) (30a);
Neutrino Development Corp. v. SonoSite, Inc., 337 F. Supp.
2d 937 (S.D. Tex. 2004) (18a).
Other judgments and orders from the United States
District Court for the Southern District of Texas are as
a
“
follows: Neutrino Development Corp. v. SonoSite, Inc., No.
H-01-2484, 2007 WL 998636 (S.D. Tex. Mar. 30, 2007)
(105a) (awarding costs); Neutrino Development Corp. v.
SonoSite, Inc., No. H-01-2484, 2007 WL 1040697 (S.D. Tex.
Mar. 30, 2007) (89a) (denying attorneys’ fees).
Il. JURISDICTION
The United States District Court for the Southern District
of Texas entered judgment on March 21, 2006, and the United
States Court of Appeals for the Federal Circuit entered
judgment on December 8, 2006. The Federal Circuit entered
the order denying the request for panel rehearing and
rehearing en banc on January 19, 2007. This Court has
jurisdiction pursuani to 28 U.S.C. § 1254(1).
IV. STATUTES INVOLVED
35 U.S.C. § 112, | 1, provides as follows:
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, or
with which it is most nearly connected, to make
and use the same, and shall set forth the best mode
contemplated by the inventor of carrying out his
invention. .
The full text of § 112 is included within the Appendix at
1 33a.
3
35 U.S.C. § 132(a) provides, in pertinent part, that
“[njo amendment shall introduce new matter into the
disclosure of the invention.” The full text of § 132 is included
within the Appendix at 135a.
V. STATEMENT OF THE CASE
This is a patent infringement case, and the United States
District Court for the Southern District of Texas, which was
the court of first instance, had jurisdiction pursuant to
28 U.S.C. §§ 1331 and 1338(a) because this case arose under
the patent laws of the United States (35 U.S.C. § 100).
A. Material Facts
Richard T. Redano, an independent inventor of numerous
patents, and a registered patent attorney, is the inventor of
United States Patent No. 6,221,021, titled, “Method and
Apparatus for Penile Hemodynamic Stimulation, Monitoring,
and Drug Delivery Acceleration” (“the ‘021 patent”).
Neutrino Development Corporation (“Neutrino”),
a technology marketing and licensing corporation, is the
assignee of the ‘021 patent.
SonoSite, Inc. (“SonoSite”), is a manufacturer and
provider of diagnostic medical ultrasound devices and
services. Specifically, SonoSite manufactures the following
products, all of which have been accused of infringing the
‘021 patent: (1) SonoSite 180; (2) SonoHeart; (3) SonoSite
180 Plus; and (4) SonoHeart Plus. These products are
portable, hand-held devices, capable of measuring certain
hemodynamic parameters—such as blood flow—through the
use of ultrasound. Neutrino Dev. Corp., 337 F. Supp. 2d at
938.
4
The ‘021 patent claims priority from, and is a
continuation-in-part of, an application filed on September
9, 1997, which is now United States Patent No. 5,947,901
(“the ‘901 patent”). The ‘021 patent discloses apparatus and
method embodiments wherein an ultrasound device may be
used in a therapeutic mode and/or a diagnostic mode.
(U.S. Patent No. 6,221,021 Bl, col. 1, lines 15-17.) Ina
therapeutic mode, the device is used to correct erectile
dysfunction by stimulating the flow of blood in a penis
(U.S. Patent No. 6,221,021 Bl, col. 1, lines 1-22), whereas
in a diagnostic mode, the device measures certain
hemodynamic parameters, such as blood flow. (U.S. Patent
No. 6,221,021 Bl, col. 7, lines 25-27.) The claims in the
‘021 patent are directed only to the diagnostic embodiment
of the disclosed apparatus.
On May 10, 2000, an amendment was filed in response
to the initial office action. The amendment at issue appears
at col. 6, line T8=20, and it reads as follows: “As shown in
FIG. 2, the ultrasonography generator unit 30 is sized to be
grasped or held in a user’s hand.” (U.S. Patent No. 6,221,021
B1, col. 6, lines 18-20; Amendment and Resp. to First Office
Action at 5, lines 25-26; Petitioner’s App. at 8a n.1.) In that
same amendment, new claims were added, which included
element “(a).”” Element “(a)” contains the following language:
“a portable body sized to be hand held.” (Amendment and
Resp. to First Office Action at 5-6.) The Examiner entered
the amendment and the new claims without objection.
(Amendment and Resp. to First Office Action at 5-6.)
Throughout the stages of this case, Neutrino has argued
that element “(a)” finds support in Fig. 2, which is the
drawing at issue, of the original ‘021 patent application. The
5
claim element in question is element “32” in the drawing.
The following illustration is Fig. 2, as it appears in the
original application:
he
FIG. 2
B. Proceedings Below
On July 24, 2001, Neutrino filed an action for patent
infringement against SonoSite, alleging that SonoSite’s hand-
held diagnostic medical ultrasound devices infringe the ‘021
patent.
After holding a Markman hearing on February 20, 2002,
the district court, on August 21, 2003, construed the meaning
of certain words and phrases. Only one of the phrases—
“a portable body sized to be hand held”— is relevant to this
petition. That phrase appears in each of the independent
claims at issue in the ‘021 patent as element “(a).” The district
court construed the phrase as follows: “‘A portable body sized
to be hand held’—A body that is sized such that it can be
6
held by hand and, so held, moved from one location to
another.” (132a.)
On March 21, 2006, the district court granted SonoSite’s
motion for summary judgment of patent invalidity, holding
that claims 8, 20, and 25, and all claims dependent thereon,
of the ‘021 patent were invalid for failure to comply with
35 U.S.C. §§ 112,49 1, and 132(a). (3a.) On the same day, the
district court entered its Final Judgment, in which it did the
foilowing: (1) invalidated claims 8, 20, and 25, and all claims
depending thereon; (2) reversed its summary judgment
finding of literal infringement of these claims; and (3)
dismissed with prejudice Neutrino’s claims of infringement.
Neutrino Dev. Corp., 423 F. Supp. 2d at 680. The district
court found claims 8, 20, and 25, and all claims depending
thereon, invalid because of “new matter” that it determined
was found in element “(a)” of each claim (“a portable body
sized to be hand held”).
Neutrino appealed to the United States Court of Appeals
for the Federal Circuit. In the briefs that it filed in the Federal
Circuit, Neutrino argued, inter alia, that the district court
erred in holding that the claims were invalid because the
district court disregarded binding precedent that provides that
patent drawings alone may be relied upon, in certain
Situations, to support claim limitations. After oral argument,
the Federal Circuit affirmed the judgment of the district court
without rendering a written opinion. Neutrino petitioned the
Federal Circuit for a rehearing and for a rehearing en banc,
but the Federal Circuit denied the petition.
7
VI. REASONS FOR GRANTING THE PETITION
This Court should grant Neutrino’s Petition for a Writ
of Certiorari for the following reasons: (1) the law in the
Federal Circuit relating to the reliance upon patent drawings
alone is in conflict, and in need of clarification; and (2) this
Court has never addressed whether, and to what extent, patent
drawings alone may be relied upon to support claim
limitations, and such an important question should be settled
by this Court. See Sup. Ct. R. 10 (providing reasons
considered by the Court when determining whether to grant
a petition for a writ of certiorari).
A. Binding Federal Circuit Law Is in Conflict with Other
Binding Federal Circuit Law
Ordinarily, conflicts in the law regarding the same matter
occur between different courts located in different
jurisdictions, and on numerous occasions, this Court has
granted writs of certiorari to resolve such conflicts when the
conflicts concerned the same important matters. See Thomas
W. Adams, The 1988 Revision of 28 U.S.C. § 1391(c):
Corporate Venue Is Now Equivalent to In Personam
Jurisdiction Effects on Civil Actions for Patent Infringement,
39 Clev. St. L. Rev. 357, 369 (1991) (“Historically, many of
the Supreme Court’s grants of certiorari have been
necessitated by conflicts between the Circuit Courts of
Appeal.”). It is rather unusual for there to exist an actual
conflict in the law of the same circuit, and this is because
conflicting decisions are overruled by the same circuit that
rendered them, thereby removing the conflict. See Wisniewski
v. United States, 353 U.S. 901, 902 (1957) (stating that
“(ijt is primarily the task of a Court of Appeals to reconcile
8
its internal difficulties”). Thus, there is normally little need
for this Court to become involved.
However, since the advent of the United States Court of
Appeals for the Federal Circuit, the Federal Circuit is the
only appellate court, other than this Court, that can hear
patent-related appeals, where the patent issue is raised in the
complaint, as in the case at bar. See 28 U.S.C. § 1295(a)(1)
(2006) (providing that “(t]he United States Court of Appeals
for the Federal Circuit shall have exclusive jurisdiction .. .
of an appeal from a final decision of a district court of the
United States . . . if the jurisdiction of that court was based,
in whole or in part, on [28 U.S.C. § 1338]”). Consequently,
if one Federal Circuit decision conflicts with another Federal
Circuit decision concerning the same matter, and both
decisions still stand, such a conflict will rarely be addressed
because it is assumed that the Federal Circuit will resolve
conflicts within its own court. See Wisniewski, 353 U.S. at
902. Moreover, it is simply counterintuitive to think that the
same court could be in conflict with itself. Nevertheless, with
regard to the issue presented in this petition, the Federal
Circuit has created a conflict between two prior decisions,
both of which still stand.
1. The Conflict at Issue
The conflict at issue relates to whether, and to what
extent, patent drawings alone may be relied upon to support
claim limitations. The Federal Circuit has decided two
seminal cases related to this matter': (1) Hockerson-
' There are other Federal Circuit cases that have addressed this
issue as well. See, e.g., Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555,
1566-67 (Fed. Cir. 1991) (“[T]he possibility that the ‘081 drawings
may provide an adequate § 112 ‘written description’ of the subject
matter of ... the claims ... should have been considered.”’).
9
Halberstadt, Inc. v. Avia Group International, Inc., 222 F.3d
951 (Fed. Cir. 2000); and (2) Koito Manufacturing Co. v.
Turn-Key-Tech, LLC, 381 F.3d 1142 (Fed. Cir. 2004). Both
decisions still stand, with one, Hockerson-Halberstadt,
holding that support for precise proportions made in claims
_ cannot be found in drawings, and the other, Koito,
determining that drawings can support claim limitations when
those limitations disclose relative dimensions.
Until recently, these two decisions were not in conflict.
However, after the district court issued its opinion in which
it announced that situations regarding “precise” proportions
recited in the claims were the same, under Federal Circuit
law, as situations regarding “relative size,”’ it created a
conflict between its decision and those of the Federal Circuit,
and the Federal Circuit was presented with an opportunity
to correct this misinterpretation of its own decisions. Yet the
Federal Circuit did not to do so, despite Neutrino having
apprised it of the inconsistency on two separate occasions.’
Instead of addressing, and resolving, this important issue,
the Federal Circuit affirmed the district court’s judgment
without even rendering a written opinion, thus creating the
conflict at issue. Accordingly, what was once lucid Federal
Circuit law is now conflicted. As such, a patentee confronted
? Neutrino Dev. Corp., 423 F. Supp. 2d at 678 (stating that “the
Court does not believe that the Federal Circuit in Hockerson-
Halberstadt intended for ‘precise proportions’ to carry a meaning
distinct from ‘relative size’”).
> In its Brief and in its Petition for Rehearing and Suggestion
for Rehearing En Banc, Neutrino notified the Federal Circuit that
the district court had misconstrued binding Federal Circuit law.
(Br. of Pl.-Appellant at 20-21; Pet. for Reh’g & Suggestion for Reh’g
En Banc at 1-9.)
10
with the issue at hand is faced with the precarious and
unenviable task of attempting to determine whether the pane!
of judges deciding the case will follow one decision. or the
other. This creates uncertainty in the law, which directly
affects all patent holders and potential patent holders, and,
on a grander scale, American business as a whole, for if such
a conflict is not resolved, a myriad of patents could be
invalidated.
2. Neutrino’s Reliance upon Koito
Neutrino relied upon Koito, and it was never determined
by either the district court or the Federal Circuit that the ‘021
patent did not fit within the reasoning of that decision. Rather,
the district court misconstrued Federal Circuit precedent, and
the Federal Circuit exacerbated this problem by affirming
the judgment, thereby unnecessarily creating a conflict.
Neutrino’s reliance upon Koito was founded upon the
fact that the Federal Circuit in that case decided that drawings
alone could be relied upon to support claim limitations, when
those limitations relate to relative dimensions. Koito Mfg.
Co., 381 F.3d at 1155. In the present case, Figure 1 of the
‘268 patent clearly shows that flow channel 6 is ‘significantly
thicker and wider’ than the adjacent mold cavity 2. Figure |
thus demonstrates that the inventor was ‘in possession’ of
the patent claims, including the claim limitation speaking to
the relative dimensions of the flow channel, and thus that
1]
the written description requirement was satisfied.” (emphasis
added)). The drawing that follows is Figure 1 from Koito:
The claim limitation at issue in this case—”a portable
body sized to be hand held”—is nothing more than a
limitation relating to relative size.* It does not speak to any
precise proportions, and because of this, Hockerson-
Halberstadt, and its prohibition against reliance upon
drawings to support precise proportions, is inapplicable.
3. The Only Solution-Is a Granting of the Writ
Rarely does this Court hear cases involving only an
intracircuit conflict created by different panels of judges
deciding the same matter in different, and conflicting, ways.
In denying petitions based on intracircuit conflicts, this Court
* This is obvious because no specific measurements, relating
to the portable body, were provided, which precludes reaching a
determination that any precise proportions are involved. Moreover,
the portable body, as it is described in the limitation, must relate to
something. That something is the hand of a human such as a hand
grasping a pistol grip 10 in Fig. 2. Furthermore, there exists an
abundance of evidence, offered by Neutrino’s experts, supporting
the fact that the disclosure in the drawing (Fig. 2) reasonably conveys
to one skilled in the art that the claim limitation at issue finds support
in the drawing.
12
has explained that such conflicts should be resolved by the
court of appeals in which the conflict arose. See Wisniewski,
353 U.S. at 902. This is accomplished through en banc
review. See Fed. R. App. P. 35(a)(1) (explaining that “[a]n
en banc hearing or rehearing is not favored and ordinarily
will not be ordered unless ... en banc consideration is
necessary to secure Or maintain uniformity of the court’s
decisions”). As discussed in Part VI.B., below, there is
another reason for granting the writ aside from the intracircuit
conflict issue. Nevertheless, even if the intracircuit conflict
was the only argued basis for granting the writ, the Court
should still grant it because the reasoning behind the Court's
denial of petitions for writ based upon intracircuit conflicts
is inapposite to the present scenario. This is because the
foundation upon which that reasoning has been based is, in
the instant case, on less than solid ground due to the Federal
Circuit’s denial of Neutrino’s Petition for Rehearing and
Suggestion for Rehearing En Banc.
It is also worth mentioning that this Court granted
certiorari to hear the case of Markman vy. Westview
Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995), despite the
fact that that case had already been decided by the Federal
Circuit while sitting en banc. See Markman v. Westview
Instruments, Inc., 517 U.S. 370 (1996). Prior to the Federal
Circuit’s en banc decision, there was an apparent conflict
between different Federal Circuit decisions relating to the
same matter (claim construction). See Markman, 52 F.3d at
976 (“The opinions of this court have contained some
inconsistent statements as to whether and to what extent claim
construction is a legal or factual issue, or a mixed issue.”’).
Although this conflict was resolved through the en banc
rehearing of the case, this Court still granted certiorari. This
is further support for the argument that the Court should grant
4
13
certiorari in the instant action because the conflict at issue
was not resolved by the Federal Circuit.
Neutrino diligently pursued every option available to it
in attempting to convince the Federal Circuit that a conflict
existed between binding Federal Circuit precedent, and this
diligence is evidenced by the arguments presented by
Neutrino in its petition for rehearing. Yet the Federal Circuit
refused to address the conflict, thereby failing to adhere to
the doctrine of stare decisis. To put it another way, the system
failed, and it is desperately in need of repair by this Court
because the conflict will not be resolved by the Federal
Circuit.
Therefore, the newly created conflict regarding whether
patent drawings may be relied upon to support claim
limitations should be resolved by this Court, especially after
considering that the Federal Circuit was presented with an
opportunity to resolve it, but refused to do so.
B. This Court Should Settle the Issue of Whether, and
to What Extent, Patent Drawings May Be Relied
Upon
The United States Supreme Court has never directly
addressed the issue presented, and it is imperative that the
Court now resolve whether, and in what instances, patent
drawings alone may be relied upon to support claim
limitations. This issue directly affects two of the most
fundamental federal statutes relating to the law of patents:
(1) 35 U.S.C. § 112; and (2) 35 U.S.C. § 132. One of these
statutes, § 112, requires a written description of the invention
to be patented, and without such a written description, no
. patent will issue. The other, § 132, prohibits new matter from
14
being added by amendment into the disclosure of the
invention. If either of these statutes are ignored or construed
too liberally—either by a patentee, the United States Patent
and Trademark Office, or a court—then an overabundance
of patents will issue, many of which will likely be declared
invalid, with the end result being a complete waste of judicial
resources. On the opposite end of the spectrum, if the statutes
are applied in an aggressively rigid fashion, there will be a
dearth of patents because many inventions deserving of a
patent will go unpatented, and many deservingly valid patents
will be invalidated.
As the issue now stands, based upon the Federal Circuit’s
affirmance of the district court’s published opinion, a patentee
is likely° precluded—regardless of the circumstances—from
ever relying upon drawings alone to find support for claim
limitations. This places patent law in the latter situation
described above. Such a result is inimical to the patent
system, not to mention that it practically renders meaningless
a federal statute—35 U.S.C. § 113, which requires drawings.
See 35 U.S.C. § 113 (2001)
The applicant shall furnish a drawing where
necessary for the understanding of the subject
matter sought to be patented.... Drawings
submitted after the filing date of the application
may not be used (1) to overcome any insufficiency
of the specification due to lack of an enabling
disclosure or otherwise inadequate disclosure
therein, or (ii) to supplement the original
* The word “likely” is employed because the law relating to
this issue is altogether ambiguous due to the conflict discussed in
Part VI.A. of this petition.
15
disclosure thereof for the purpose of interpretation
of the scope of any claim.
(Emphasis added).
Whether a patentee may rely upon patent drawings to
support claim limitations affects the very corpus of patent
law, and such an important issue should be decided by this
Court to bring clarity and consistency to the law. For as it
currently exists, it is entirely unclear whether a patentee may
rely upon patent drawings to support claim limitations.
VII. CONCLUSION
For the foregoing reasons, the petition for a writ of
certiorari should be granted.
Respectfully submitted,
Scott D. Marrs
BEIRNE, MayNARD & Parsons, L.L.P.
1300 Post Oak Boulevard
Suite 2500
Houston, Texas 77056
(713) 623-0887
Counsel for Petitioner
APPENDIX
la
APPENDIX A — JUDGMENT OF THE UNITED STATES
COURT OF APPEALS FOR THE FEDERAL CIRCUIT
DATED AND FILED DECEMBER 8, 2006
UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT
No. 2006-1316
NEUTRINO DEVELOPMENT CORPORATION,
Plaintiff/Counterclaim Defendant-
Appellant,
and
RICHARD T. REDANO,
Counterclaim Defendant,
v.
SONOSITE, INC.,
Defendant/Counterclaimant-
Appellee.
JUDGMENT
ON APPEAL from the UNITED STATES DISTRICTCOURT.
SOUTHERN DISTRICT OF TEXAS
In CASE NO(S). 01-CV-2484
This CAUSE having been heard and considered, it is
ORDERED and ADJUDGED:
2a
Appendix A
Per Curiam: (MAYER and PROST, Circuit Judges, WHYTE,
District Judge*):
AFFIRMED. See Fed. Cir. R. 36.
ENTERED BY ORDER OF THE COURT
s/ Jan Horbaly
Jan Horbaly, Clerk
DATED DEC -8 2006
* Honorable Ronald M. Whyte, United States District Court
for the Northern District of California, sitting by designation.
3a
APPENDIX B — MEMORANDUM AND ORDER OF
THE UNITED STATES DISTRICT COURT FOR THE
SOUTHERN DISTRICT OF TEXAS,
HOUSTON DIVISION
DATED MARCH 21, 2006
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF ‘TEXAS
HOUSTON DIVISION
CIVIL ACTION NO. H-01-2484
NEUTRINO DEVELOPMENT CORPORATION,
Plaintiff,
¥.
SONOSITE, INC.,
Defendant.
MEMORANDUM AND ORDER
Pending before the Court is Defendant’s Motion for
Summary Judgment of Invalidity Based on New Matter
(Dkt.# 279). The Court, after reviewing the motion, the
responses of the parties and the relevant law, is of the opinion
that the motion should be GRANTED.
Factual and Procedural Background
This is an action for patent infringement brought by
Neutrino Development Corporation (“Neutrino”) against
Sonosite, Inc. (“Sonosite”). Neutrino is the owner of United
4a
Appendix B
States Patent No. 6,221,021 (“the ‘021 patent’). Neutrino
alleges that four devices manufactured and marketed by
Sonosite, the Sonosite 180, SonoHeart, Sonosite 180 PLUS,
and the SonoHeart PLUS, infringe on the ‘021 patent.
The ‘021 patent application was filed on May 30, 1999,
and claimed priority to an earlier patent application,
Application Serial No. 08/926, 209, filed on September 9,
1997, which was issued as U.S. Patent No. 5,947,901 (‘‘the
‘901 patent application” and the “ ‘901 patent,” respectively).
The ‘021 patent application, entitled “Method and Apparatus
for Penile Hemodynamic Stimulation, Monitoring, and Drug
Delivery Acceleration,” described a device for “stimulating
and/or monitoring hemodynamic activity, such as blood flow,
in a penis.” U.S. Patent No. 6,221,021] at col. 1, ll. 15-16.
On February 4, 2000, the U.S. Patent & Trade Office (“PTO”)
rejected all of the claims in the original ‘021 Patent
Application. In May 2000, Redano amended the pending ‘021
patent application. Part of that amendment became the claims
of the ‘021 patent, which was issued on April 24, 2001.
Defendant Sonosite began as a division of ATL
Ultrasound, Inc., and was spun off as a public company in
April 1998. Sonosite unveiled its first public product in the
realm of hand-carried ultrasound devices, the Sonasite 180,
on May 17, 1999. Sonosite began selling the device in June
1999. In January 2000, Sonosite launched its second product,
the SonoHeart. In April 2001, Sonosite launched a new
generation of these two devices with its introduction of the
SonoSite 180 PLUS and the SonoHeart PLUS.
Sa
Appendix B
On July 24, 2001, Neutrino filed this action, alleging
that Sonosite had illegally used Redano’s invention and
infringed the ‘021 patent. Sonosite answered the complaint
on August 14, 2001, asserting that the ‘021 patent claims are
not infringed and are invalid, and counterclaimed for
declaratory judgment of non-infringement and invalidity.
On February 20, 2002, after extensive briefing, the Court
held a one-day Markman hearing on claim construction. On
October 9, 2002, the Court stayed all proceedings pending
the Court’s Markman and summary judgment rulings. The
Court issued its claim construction on August 21, 2003.
Subsequently, the Court granted Neutrino’s Motion for
Summary Judgment on Infringement (Dkt. # 136) finding
that Sonosite’s devices literally infringed the ‘021 patent and
that the reverse doctrine of equivalents was not applicable
(Dkt.# 162).
Summary Judgment Standard
Summary judgment is proper if “the pleadings,
depositions, answers to interrogatories, and admissions on
file, together with the affidavits, if any, show that there is-no
genuine issue as to any material fact and that the moving
party is entitled to a judgment as a matter of law.” Fed. R.
Civ. P. 56(c); see also Christopher Village, LP v. Retsinas,
190 F.3d 310, 314 (Sth Cir.1999). “For any matter on which
the non-movant would bear the burden of proof at trial... ,
the movant may merely point to the absence of evidence and
thereby shift to the non-movant the burden of demonstrating
by competent summary judgment proof that there is an issue
of material fact warranting trial.” Transamerica Ins. Co. v.
6a
Appendix B
Avenell, 66 F.3d 715, 718-19 (Sth Cir.1995); see also Celotex
Corp. v. Catrett, 477 U.S. 317, 323-25, 106 S.Ct. 2548, 91
L.Ed.2d 265 (1986). To prevent summary judgment, the non-
movant must “respond by setting forth specific facts” that
indicate a genuine issue of material fact. Rushing v. Kansas
City S. Ry. Co., 185 F.3d 496, 505 (Sth Cir.1999).
When considering a motion for summary judgment, the
Court must view the evidence in the light most favorable to the
non-movant and draw all reasonable inferences in favor of the
non-movant. See Samuel v. Holmes, 138 F.3d 173, 176 (Sth
Cir.1998); Texas v. Thompson, 70 F.3d 390, 392 (Sth Cir. 1995).
“The court may not undertake to evaluate the credibility of the
witnesses, weigh the evidence, or resolve factual disputes; so
long as the evidence in the record is such that a reasonable jury
drawing all inferences in favor of the nonmoving party could
arrive at a verdict in that party’s favor, the court must deny the
motion.” /nt’l Shortstop, Inc. v. Rally’s, Inc., 939 F.2d 1257,
1263 (Sth Cir.1991). However, the non-movant cannot avoid
summary judgment by presenting only “conclusory allegations,”
or “unsubstantiated assertions,” such as the bare allegations of
a complaint, but must present sufficient evidence, such as sworn
testimony in a deposition or affidavit, to create a genuine issue
of material fact as to the claim asserted. Little v. Liquid Air
Corp., 37 F.3d 1069, 1075 (Sth Cir. 1994) (en banc).
Patent cases are as amenable to summary judgment as any
other case when no genuine issue of material fact exists and the
movant is entitled to judgment as a matter of law. See Warner-
Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 39, 117
S.Ct. 1040, 137 L.Ed.2d 146 (1997); Johnston v. IVAC Corp.,
885 F.2d 1574, 1576-77 (Fed.Cir.1989); SRI Int’l v. Matsushita
Elec. Corp. of Am., 775 F.2d 1107, 1116 (Fed.Cir.1985).
Ta
Appendix B
However, a court should apply a somewhat more exacting
scrutiny to a motion for summary judgment based on invalidity
because there is a statutory presumption that an issued patent is
valid. This presumption “is based in part on the expertise of
patent examiners presumed to have done their jobs.” Brooktree
Corp. v. Adv. Micro Devices, Inc., 977 F.2d 1555, 1574
(Fed.Cir.1992). The Federal Circuit has held that “ ‘the fact
that the Patent Office allows ... an amendment without
objection thereto as new matter (within the meaning of Title
35 U.S.C. § 132) is entitled to an especially weighty presumption
of correctness.’ ” Jd. (quoting In re Smythe, 480 F.2d 1376, 1385
n. 5 (Cust. & Pat.App.1973)). The Court has taken this strong
‘presumption into due consideration.
Analysis
The new matter prohibition of 35 U.S.C. § 132 “serves to
ensure that the patent applicant was in full possession of the
claimed subject matter on the application filing date.” TurboCare
Division of Demag Delaval Turbomachinery Corp. v. General
Elec. Co., 264 F.3d 1111, 1118 (Fed.Cir. 2001). The relevant
portion of § 132(a) reads, “[nJo amendment shall introduce new
matter into the disclosure of the invention.”” When an applicant
amends the specification and/or claims after the original filing
date, as Richard Redano did in this case, “the new claims or
other added material must find support in the original
specification.” /d. (citing Schering Corp. v. Amgen Inc., 222
F.3d 1347, 1352 (Fed.Cir.2000)). The relevant inquiry is whether
one of ordinary skill in the art would have determined from the
original application that the applicant was in possession of the
amended subject matter at the time of the original application
filing date. Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d
1570, 1575 (Fed.Cir.1985). In simpler terms, an amendment
8a
Appendix B
may only clarify, not change, the written description in the
original patent application.
Sonosite contends that the claims of the ‘021 patent that
are the subject of this lawsuit ' are invalid because the hand-
held size of the ultrasonography generator was “new matter”
under § 132 introduced through amendments to the
specifications and claims of the ‘021 patent application.
Sonosite contends that the amendments specifying that the
ultrasonography generator is sized to be hand-held found support
neither explicitly nor inherently in the original patent application.
Neutrino argues in response that (1) the diagrams in the original
patent application indicate by proportion that the
ultrasonography generator would be sized small enough to be
hand-held, and (2) a genuine issue of material fact exists as to
whether a person of ordinary skill in the art would have readily
understood U.S. Pat. No. 5,578,060 (“Pohl patent”),
incorporated by reference into the ‘021 patent application, to
describe a hand-held ultrasonography generator. The Court will
consider each of these arguments below.
Neutrino contends that the hand-held size of the
ultrasonography generator was disclosed inherently in the
original application. The Federal Circuit has held that “[{iJn order
for a disclosure to be inherent, ‘the missing descriptive matter
must necessarily be present in the [original] application’s
specification such that one skilled in the art would recognize
such a disclosure.” TurboCare , 264 F.3d at 1119 (quoting Tronzo
v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed.Cir.1998)). Neutrino
1. Neutrino has asserted that Sonosite is infringing claims 8-14
and 20-27. See Dkt. # 75, p. 4. Of those, claims 8, 11-13, 20, 21, 23-27
include (directly or by reference) the amended language indicating that
the ultrasonography generator is sized to be hand-held.
9a
Appendix B
argues that the proportions implied by the diagrams in the
original application and in the Pohl patent necessarily lead one
of ordinary skill in the art to conclude that the ultrasonography
generator was intended to be small enough to be hand-held. In
response, Sonosite argues that the possibility that the
ultrasonography generator depicted in the diagrams and
disclosed in the Pohl patent could be sized to be hand-held is
not sufficient to qualify as inherent disclosure. Based on the
analysis adopted by the Federal Circuit, the Court agrees with
Sonosite that one of ordinary skill in the art must conclude that
the diagrams and/or the Pohl patent necessarily disclose a hand-
held ultrasonography generator. TurboCare, 264 F.3d at 1119.
The conclusion that the diagrams or Pohl patent might disclose
a hand-held ultrasonography generator is insufficient to stand
as inherent support for an application amendment. To survive
this motion for summary judgment, the diagrams must
unequivocally depict an ultrasonography generator sized to be
hand-held and/or the Pohl patent must explicitly disclose an
ultrasonography generator that is sized to be hand-held. In the
following paragraphs, the Court will review the specification
diagrams and the Pohl patent to determine whether any
reasonable jury could determine that a person of ordinary skill
in the art of designing, testing, and building medical ultrasound
devices could conclude that the diagrams and/or patent
incorporated by reference necessarily disclose a hand-held
ultrasonography generator.
1. Patent Application Diagrams
Sonosite argues that the dravings in the original
‘021 patent application do not disclose the size of the
ultrasonography generator because (1) patent drawings cannot
be relied upon to show particular sizes where the specification
10a
Appendix B
is silent on the issue of size, and (2) the proportions loosely
depicted in the drawings, if taken literally, would produce an
untenable result. Neutrino objects to the applicability of the cases
cited by Sonosite for the proposition that drawings cannot
establish sizes on the grounds that these cases do not preclude
reliance on drawings to show general proportions as opposed
to specific dimensions. Neutrino contends that the original
specification explicitly discloses a hand-held transducer housing
(a fact that Sonosite does not dispute) and the drawings show
the proportionate size of each component of the claimed
invention in relation to the transducer housing. In Figure 2,
reproduced below, the ultrasound generator and the
ultrasonography generator are smaller than the hand-held
transducer housing.’
Om)
Q”
2. Unit 32 of Figure 2 depicts the ultrasonography generator.
The component comprised of units 10, 18, and 24 represents the
hand-held transducer housing.
lla
Appendix B
Neutrino contends that one of ordinary skill in the art would
understand from this drawing that the ultrasonography
generator is proportionately smaller than the hand-held
transducer housing and, therefore, is itself sized to be hand-
held. However, Figure 2 contains neither a scale nor
dimensions and under well-established Federal Circuit
precedent, “patent drawings do not define the precise
proportions of the elements and may not be relied upon to
show particular sizes if the specification is completely silent
on the issue.” Hockerson-Halberstadt, Inc. v. Avia Grp. Int'l,
222 F.3d 951, 956 (Fed.Cir.2000). Neutrino argues that
Hockerson-Halberstadt and other similar cases do not apply
to depictions of general proportions and “relative size.’’?
Neutrino also argues that the ‘021 patent application
specification was not “completely silent” on the issue of
relative size because it incorporated the Pohl patent by
reference. The Court rejects the latter argument on the
grounds that the requirement that the specification not be
“completely silent” on the issue of size in order to imply
size in a drawing necessitates an explicit disclosure in the
specification, not an implicit disclosure such as another patent
incorporated by reference. To that end, the Pohl patent also
lacks any explicit reference to the size of the ultrasonography
generator. The implication of size within another patent
incorporated by reference is insufficient to support
contentions about the relative size of components depicted
in an unspecific drawing. No reasonable jury could determine
that a person of ordinary skill in the art would have
readily recognized the size (specific or relative) of the
ultrasonography generator from the drawings in the ‘021
patent.
3. Dkt. # 292, p. 9.
12a
Appendix B
Furthermore, the Court does not believe that the Federal
Circuit in Hockerson-Halberstadt intended for “precise
proportions” to carry a meaning distinct from “relative size.”
The issue on appeal in Hockerson-Halberstadt was “whether
the district court correctly construed the term ‘central
longitudinal groove to require that the width of the groove’
must be less than the combined width of the fins.” Hockerson-
Halberstadt, 222 F.3d at 954. The defendant in Hockerson-
Halberstadt made the argument that statements submitted
by the inventor during the prosecution about the width of
the groove conflicted with the drawings in the specification
of the original patent application and, therefore, the
conflicting prosecution history should not be used to construe
the claims. The Federal Circuit rejected the defendant’s
argument on the grounds that the patent “is devoid of any
indication that the proportions of the groove and fins are
drawn to scale.” Id. at 956 (emphasis added). The Federal
Circuit determined that the drawings could not be relied upon
to establish the size of the groove relative to the fins.
Ultimately, the Federal Circuit held that “a reasonable
competitor, being aware that figures in a patent are not drawn
to scale unless otherwise indicated, would” have accepted
the specific statements about size in the prosecution history.’
4. The Court notes that Hockerson-Halberstadt was about claim
construction, not the issue of “new matter.” As in the present case,
the district court in Hockerson-Halberstadt would not have evaluated
the propriety of the amended language under § 132 while issuing
the claim construction. The process of claim construction assumes
the validity of the issued patent. The defendant in Hockersen-
Halberstadt made the argument that a particular claim should be
interpreted in light of the apparent proportions in the specification
drawings. Because specific language in the prosecution history
(Cont'd)
13a
Appendix B
The Court finds that it was precisely the sort of argument
that Neutrino attempts to advance here that the Federal
Circuit sought to preclude in Hockerson-Halberstadt. Put
simply, the Federal Circuit prohibits reliance upon unspecific
drawings to support claim limitations.° Therefore, the Court
finds that no reasonable juror could conclude that a person
of ordinary skill in the art would have relied upon the relative
sizes depicted in the specification drawings of the original
‘021 patent application to determine the size of the
ultrasonography generator.
2. The Pohl Patent
Sonosite contends that the Pohl patent does not disclose
an ultrasonography generator sized to be hand-held on the
grounds that (1) the Pohl patent does not disclose an
ultrasonography generator at all, and (2) even if unit 14
depicted in Figure | of the Pohl patent can be treated as an
(Cont’d)
explained the relative size of the groove, the court’s analysis pittea the
prosecution disclaimer against the drawings. However, had there been
no statements about relative size in the prosecution history, the plaintiff
still would not have been able to rely on the specification drawings to
establish relative size. The outcome in this alternative scenario would
have been a claim construction without any specification about size.
5. Because the drawings in the original patent application cannot
support the amendment pertaining to the hand-held size of the
ultrasonography generator, it is not necessary to explore whether the
proportions offered by Neutrino are so factually untenable as to warrant
summary judgment. The Court does, however, note that the relative
sizes depicted in Figure 2, if taken literally, would suggest an
ultrasonography generator not merely hand-held, but small enough to
fit in the palm of one’s hand.
l4a
Appendix B
equivalent of the ultrasonography generator in the ‘021
patent, the device disclosed in the Pohl patent is not
necessarily sized to be hand-held. The Court will address
the latter argument first because it is dispositive.
The component identified in the Pohl patent as analogous
to the ultrasonography generator in the ‘021 patent is depicted
as unit 14 in Figure 1 of the Pohl patent. The Pohl patent
states that Figure | depicts “a relatively large physical therapy
~ apparatus.”® However, the description also states that the
preferred embodiment depicted in Figure | could “be much
smaller so as to be portable without departing from the spirit
and scope of the present invention.”’ If a device sized small
enough to be portable falls within the scope of the Pohl patent,
it follows that unit 14, which is a component of the device,
can potentially be sized small enough to be portable without
broadening the scope of the patent. As an initial matter,
Sonosite argues that being sized to be “portable” is not
equivalent to being sized to be hand-held. Sonosite contends
that portable could mean “capable of being moved from place
to place” on a cart.* However, even if the Court accepts that
a person of ordinary skill in the art would understand that
unit 14 is equivalent to the ultrasonography generator in the
‘021 patent and that “portable” can include a size small
enough to be hand-held, the Pohl patent still fails to disclose
a hand-held ultrasonography generator sufficient to inherently
support that limitation as an amendment to the original ‘021
patent application. The Federal Circuit has specified that
6. Dkt. # 279, Exhibit 1] (Poh) patent).
7. Id.
8. Dkt. # 279, p. 12.
,
15a
Appendix B
“(t]he missing descriptive matter must necessarily be present
in the [original] application’s specification such that one
skilled in the art would recognize such a disclosure.”
TurboCare, 264 F.3d at 1119 (emphasis added). The
possibility that a variant of the device depicted in Figure |
could be sized “much smailer” so as to be “portable” cannot
support the conclusion that unit 14 in Figure 1 is necessarily
hand-held. The Federal Circuit has been instructive on this
point:
It is true that the specification “does not have to
provide in haec verba support for the claimed
subject matter at issue.” Purdue Pharma L.P. v.
Faulding Inc., 230 F.3d 1320, 1323 (Fed.Cir.2000)
(citing Fujikawa v. Wattanasin, 93 F.3d 1559,
1570 (Fed.Cir.1996)). Nonetheless, the disclosure
must clearly convey to one skilled in the art that
the inventor was in possession of the invention.
“Put another way, one skilled in the art, reading
the ... disclosure, must immediately discern the
limitation at issue in the claims.” /d. (citing
Waldemar Link, GmbH & Co. v. Osteonics Corp.,
32 F.3d 556, 558 (Fed.Cir.1994)) (emphasis
added). Immediacy is important because it
guarantees that the insight belongs to the author
of the specification and appears at once to the
intelligent and educated reader. It is a different
matter, however, if the language of the
specification triggers an insight that belongs to
the reader, who, having thought about the extent
of what was actually disclosed by the
specification, concludes, “This also could be done
l6a
Appendix B
another way.” In that circumstance, the reader is
conceiving of an “obvious variant” of what is
actually described, and that is not enough to satisfy
the written description requirement. See
Lockwood, 107 F.3d at 1572.
The Court finds that sizing unit 14 to be hand-held (as
opposed to more generally “portable’) qualifies as “an
obvious variant” of the explicit disclosures in the
specifications of the Pohl patent. An “obvious variant” of a
patent incorporated by reference cannot provide support for
an application amendment. To allow so many possible
permutations of a given device to fall under the umbrella of
inherent support would undermine the purpose of the written
description requirement. Therefore, the Court finds that no
reasonable juror could conclude that the Pohl patent provides
support for the amendments made to the ‘021 patent
application.
17a
Appendix B
Conclusion
The Court finds that the claims covering the improperly
amended subject matter outlined above are invalid for new
matter. Therefore, Defendant’s Motion for Summary
Judgment of Invalidity Based on New Matter (Dkt # 279) is
GRANTED. Accordingly, all remaining motions are denied
as moot.
Furthermore, the finding that independent claims 8, 20,
and 25 are invalid for new matter compels the Court to reverse
claim construction (b) in its Markman Order (Dkt.# 125) and
consequently to reverse the finding of literal infringement
in the Court’s Order of September 29, 2004 (Dkt.# 162).
Because Plaintiff's claims of infringement under 35 U.S.C.
§ 271(a) and (b) rely upon the inclusion of the invalid claims,
the Court is also of the opinion that Plaintiff’s claims for
direct infringement and inducing infringement should be
DISMISSED with prejudice.
It is so ORDERED.
A final judgment shall be issued separately.
Signed this 21st day of March, 2006.
s/ John D. Rainey
JOHN D. RAINEY
UNITED STATES DISTRICT JUDGE
18a
APPENDIX C — MEMORANDUM AND ORDER OF THE
UNITED STATES DISTRICT COURT FOR THE
SOUTHERN DISTRICT OF TEXAS, HOUSTON
DIVISION DATED SEPTEMBER 30, 2004
(Re: Plaintiff's Motion for Summary Judgment
on Infringement)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF TEXAS
HOUSTON DIVISION
No. CIV.A.H-01-2484
NEUTRINO DEVELOPMENT CORPORATION,
Plaintiff,
v.
SONOSITE, INC.,
Defendant.
Sept. 30, 2004.
MEMORANDUM AND ORDER
RAINEY, District Judge.
Pending before the Court is Plaintiff's Motion for
Summary Judgment on Infringement (Dkt.# 136). The Court,
after reviewing the motion, the responses of the parties and
the relevant law, is of the opinion that the motion should be
GRANTED.
19a
Appendix C
Factual and Procedural Background
This is an action for patent infringement brought by
Neutrino Development Corporation (“Neutrino”) against
Sonosite, Inc. (“Sonosite”). Neutrino is the owner of United
States Patent No. 6,221,021 (“the ‘021 patent”). Neutrino
alleges that four devices manufactured and marketed by
Sonosite, the Sonosite 180, SonoHeart, Sonosite 180 PLUS,
and the SonoHeart PLUS, infringe on the ‘021 patent.
Richard T. Redano applied for a patent on the device in
question on September 9, 1997. (Application Serial No. 08/
926, 209).' The ‘021 patent, entitled “Method and Apparatus
for Penile Hemodynamic Stimulation, Monitoring, and Drug
Delivery Acceleration,” resulted from that application. It
describes a device for “stimulating and/or monitoring
hemodynamic activity, such as blood flow, in a penis.”
U.S. Patent No. 6,221,021 at col. 1, ll. 15-16.
Defendant Sonosite began as a division of ATL
Ultrasound, Inc., and was spun off as a public company in
April 1998. Sonosite unveiled its first public product in the
realm of hand-carried ultrasound devices, the Sonosite 180,
on May 17, 1999. Sonosite began selling the device in June
1999. In January 2000, Sonosite launched its second product,
the SonoHeart. In April 2001, Sonosite launched a new
generation of these two devices with its introduction of the
SonoSite 180 PLUS and the SonoHeart PLUS.
1. On May 20, 1999, Redano field a continuation in patent
application, serial No. 09/315,867 which eventually issued as the
‘021 patent. In May 2000, Redano amended the pending ‘021 Patent
Application to broaden its disclosure and expand the claims. The
‘021 patent was issued on April 24, 2001.
20a
Appendix C
On July 24, 2001, Neutrino filed this action, alleging
that Sonosite had illegally used Redano’s invention and
infringed the ‘021 patent. Sonosite answered the complaint
on August 14, 2001, asserting that the ‘021 patent claims are
not infringed and are invalid, and counterclaimed for
declaratory judgment of non-infringement and invalidity.
On February 20, 2002, after extensive briefing, the Court
held a one-day Markman hearing on claim construction. On
October 9, 2002, the Court stayed all proceedings pending
the Court’s Markman and summary judgment rulings. The
Court issued its claim construction on August 21, 2003. This
motion for summary judgment was filed as a result of the
Court’s claim construction.
Summary Judgment Standard
Summary judgment is proper if “the pleadings,
depositions, answers to interrogatories, and admissions on
file, together with the affidavits, if any, show that there is no
genuine issue as to any material fact and that the moving
party is entitled to a judgment as a matter of law.” Fed. R.
Civ. P. 56(c); see also Christopher Village, LP v. Retsinas,
190 F.3d 310, 314 (Sth Cir.1999). “For any matter on which
the non-movant would bear the burden of proof at trial... ,
the movant may merely point to the absence of evidence and
thereby shift to the non-movant the burden of demonstrating
by competent summary judgment proof that there is an issue
of material fact warranting trial.” Transamerica Ins. Co. v.
Avenell, 66 F.3d 715, 718-19 (Sth Cir. 1995); see also Celotex
Corp. v. Catrett, 477 U.S. 317, 323-25, 106 S.Ct. 2548, 91
L.Ed.2d 265 (1986). To prevent summary judgment, the non-
2la
Appendix C
movant must “respond by setting forth specific facts” that
indicate a genuine issue of material fact. Rushing v. Kansas
City S. Ry. Co., 185 F.3d 496, 505 (Sth Cir.1999).
When considering a motion for summary judgment, the
Court must view. the evidence in the light most favorable to
the non-movant and draw all reasonable inferences in favor
of the non-movant. See Samuel v. Holmes, 138 F.3d 173,
176 (Sth Cir.1998); Texas v. Thompson, 70 F.3d 390, 392
(Sth Cir. 1995). “The court may not undertake to evaluate the
credibility of the witnesses, weigh the evidence, or resolve
factual disputes; so long as the evidence in the record is such
that a reasonable jury drawing all inferences in favor of the
nonmoving party could arrive at a verdict in that party’s favor,
the court must deny the motion.” Int’! Shortstop, Inc. v.
Rally’s, Inc., 939 F.2d 1257, 1263 (Sth Cir.1991). However,
the non-movant cannot avoid summary judgment by
presenting only “conclusory allegations,” or “unsubstantiated
assertions,” such as the bars allegations of a complaint, but
must present sufficient evidence, such as sworn testimony
in a deposition or affidavit, to create a genuine issue of
material fact as to the claim asserted. Little v. Liquid Air
Corp., 37 F.3d 1069, 1075 (Sth Cir. 1994) (en banc).
Patent cases are amenable to summary judgment as any
other case when no genuine issue of material fact exists and
the movant is entitled to judgment as a matter of law. See
Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 US.
17, 39, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997); Johnston v.
IVAC Corp., 885 F.2d 1574, 1576-77 (Fed.Cir.1989); SRI
Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1116
(Fed.Cir. 1985).
22a
Appendix C
Analysis
Plaintiff Neutrino argues that Defendant’s Sonosite 180,
SonoHeart, Sonosite 180 PLUS and SonoHeart PLUS read
on every claim in the ‘021 patent, thereby establishing literal
infringement. In response, Sonosite argues that the patent is
not infringed under the “reverse doctrine of equivalents.”
Sonosite’s argument centers on the idea that the accused
devices are substantially different from the devices described
in the original patent application. Sonosite supports this
argument by asserting that the valid scope of the invention
must be determined in accordance with the principles of
35 U.S.C. § 112 before the doctrine of equivalents can be
applied. As stated by the Federal Circuit in SR/ International,
and clarified by that court in 7Jexas Instruments, Inc. v. U.S.
Int’l Trade Comm'n, 846 F.2d 1369, 1372 (Fed.Cir. 1988),
before the reverse doctrine of equivalents can be applied,
there must be a finding of literal infringement. Sonosite has
offered no evidence to suggest that the devices in question
do not infringe the patent. Rather, Sonosite argues that a fact
issue exists as to whether the accused devices are so far
changed from the invention at suit that the reverse doctrine
of equivalents applies. See Sonosite’s Response to the Motion
for Summary Judgment on Infringement, page 14. Thus it
appears to the Court that Sonosite is conceding the issue of
infringement by its argument in favor of the application of
the reverse doctrine of equivalents. However, Neutrino still
bears the burden of proving that the accused devices infringe
on the patents.
23a
Appendix C
Infringement
The determination of patent infringement is a question
of fact. Karlin Tech., Inc. v. Surgical Dynamics, Inc., 177
F.3d 968, 974 (Fed.Cir.1999). With that in mind, the court
must approach a summary judgment motion on the issue of
infringement cautiously. See SRI Int'l, 775 F.2d at 1116.
“Summary judgment is appropriate when it is apparent that
only one conclusion as to infringement could be reached by
a reasonable jury.” TechSearch, L.L.C. v. Intel Corp., 286
F.3d 1360, 1369 (Fed.Cir.2002).
Infringement analysis is a two-step process. Seal-Flex,
Inc. v. Athletic Track & Court Constr., 172 F.3d 836, 842
(Fed.Cir.1999); Markman v. Westview Instruments, Inc., 52
F.3d 967, 976 (Fed.Cir. 1995), aff’d, 517 U.S. 370, 116 S.Ct.
1384, 134 L.Ed.2d 577 (1996). First, the claims in question
must be construed as a matter of law; and second, the properly
construed claims must be compared to the accused device or
process. Markman, 52 F.3d at 976.
In a previous order, the Court construed the claims as
follows:
1. “A transducer mounting assembly moveably
connected to said body such that the distance between said
assembly and said body can be adjusted by a user using only
one hand”—-An assembly sized to contain at least one
ultrasound emitter or transducer, which is connected to the
portable body such that a user of the apparatus can cause a
change in the distance between the transducer mounting
assembly and the portable body, using only one hand.
24a
Appendix C
2. “A portable body sized to be hand held”—A body that
is sized such that it can be held by hand and, so held, moved
from one location to another.
3. “Ultrasound emitter”——At least one component, also
known as a “transducer” or “emitter,” and capable of emitting
ultrasound energy.’
Therefore, the Court proceeds to the second step in the
infringement analysis: comparing the claim, as construed by
the Court, with the accused device. Infringement means that
the accused device or process contains, either literally or
under the doctrine of equivalents, “every limitation of the
properly construed claim.” Seal-Flex, 172 F.3d at 842.
Literal infringement exists when the accused device
embodies each claim limitation precisely. Kraft Foods, Inc.
v. Int'l Trading Co., 203 F.3d 1362, 1370 (Fed.Cir.2000). If
even one component of the claim is not found in the accused
device exactly as recited in the claim, the claim does not
“read on” the accused device and there can be no literal
infringement. See Pennwalt Corp. v. Durand-Wayland, Inc.,
833 F.2d 931 (Fed.Cir. 1987). Infringement under the doctrine
of equivalents requires that the accused product contain each
limitation of the claim or its equivalent. See Warner-
Jenkinson, 520 U.S. at 40, 117 S.Ct. 1040. “A claim element
is equivalently present in an accused device if only
2. The Court held that the following terms did not need to be
interpreted because they were unambiguous: 1) “mounicd in,”
“mounted on,” “housed within,” and “top surface;” 2) “portable body
comprising a top surface;” 3) “connected to” and “coupled to;”
4) “generating an instruction;” and 5) “display.”
25a
Appendix C
‘insubstantial differences’ distinguish the missing claim
element from the corresponding aspects of the accused
device.” Sage Prods., Inc. v. Devon Indus., 126 F.3d 1420,
1423 (Fed.Cir. 1997). “Whether a component in the accused
subject matter performs substantially the same function as
the claimed limitation in substantially the samc way to
achieve substantially the same result may be relevant to this
determination.” Ethicon Endo-Surgery, Inc. v. U.S. Surgical
Corp., 149 F.3d 1309, 1315 (Fed.Cir.1998).
Neutrino argues that the devices produced by Sonosite
literally infringe on each of the patent claims. As support for
this contention, Neutrino offers the testimony, in declaration
form, of Richard Redano, the inventor of the ‘021 patent. In
his declaration, Mr. Redano compares every element of the
asserted claims of the ‘021 patent, as construed by the Court,
to the Sonosite 180, Sonosite 180 PLUS, SonoHeart, and
SonoHeart PLUS devices and concludes that every element
is literally embodied in those devices.
Mr. Redano’s declaration sets out in detail how each of
the claims is infringed by the Sonosite devices. His
declaration specifically references which portion of the
Sonosite devices pertain to each claim. For example, with
regard to the “portable body sized to be hand held”
requirement, Mr. Redano, referencing pictures of the Sonosite
devices produced in discovery, that “page P0216 and page
P0240 the body is shown grasped in a user’s hand. The body
is sized such that it can be held by hand. . .” See Declaration
of Richard Redano, attached as Exhibit A to Neutrino’s
Motion for Summary Judgment on Infringement, para. 15.
26a
Appendix C
Sonosite offers no evidence to contradict the testimony
of Mr. Redano. Rather, Sonosite argues that the reverse
doctrine of equivalents should apply in this case.
The Reverse Doctrine of Equivalents
The reverse doctrine of equivalents states that the
doctrine may be used to restrict a claim and thus defeat a
patentee’s action for infringement where a device is “so far
changed in principle from a patented article that it performs
the same or similar function in a substantially different way,
but nevertheless falls within the literal words of the claim.”
Graver Tank & Mfg. v. Linde Air Prods. Co., 339 U.S. 605,
608-09, 70 S.Ct. 854, 94 L.Ed. 1097 (1950). The Federal
Circuit, sitting en banc, phrased the inquiry as a single
question in SRI International vy. Matsushita Electric
Corporation, stating that
the reverse doctrine of equivalents...raises a fact
question, determinable on inquiry into whether a
product has been so far changed in principle that
it performs the same or similar function in a
substantially different way.
775 F.2d 1107, 1124 (Fed.Cir.1985) (en banc).
The Federal Circuit went on to say that though this
inquiry differs from the inquiry under the doctrine of
equivalents because literal infringement is inherently present
in a reverse doctrine of equivalents case, it is nonetheless
directed to a fact issue. Jd. Therefore, when a patentee
establishes literal infringement, “the accused infringer may
27a
Appendix C
undertake the burden of going forward to establish the fact
of non-infringement under the doctrine of reverse
equivalents. If the accused infringer makes a prima facie case,
the patentee, who retains the burden of persuasion on
infringement, must rebut that prima facie case.” Id.
Sonosite’s argument centers on the idea that the accused
devices are substantially different from the devices described
in the original patent application. Sonosite supports this
argument by asserting that the valid scope of the invention
must be determined in accordance with the principles of
35 U.S.C. § 112 before the doctrine of equivalents can be
applied. Sonosite furthers its contention by asserting that the
enablement and the written description requirements of
§ 112 do not support a finding that the claimed invention
enables or adequately describes a hand-held device. Rather,
Sonosite asserts that a person skilled in the art of ultrasound
would interpret the contents of the patent application, and
the specifications contained therein, as describing a hand-
held device that would connect to a standard ultrasound
imaging system that is separate and distinct from the hand-
held housing, and not an ultrasonography generator that
would fit in a hand-held enclosure.
The Court, however, has already construed the claims
of the patent to include a “body that is sized such that it can
be held by hand . . .” The claim construction also indicates
that the ultrasonography generator would be “mounted in said
body.” Additionally, the Federal Circuit made it clear in
SRI International that the relevant test was whether the
accused product was so far changed in principle that it
performs the function of the claimed invention in a
28a
Appendix C
substantially different way, not whether the accused device
is so far changed in principle that it performs the function of
the patent application, prior to any amendments in a
substantially different way. See SRI Int’l, 775 F.2d at 1124.
At that point, the court in SRI International looked to the
evidence presented regarding the ways the two products
functioned to determine whether they were substantially
different. /d. The Court has found no case where a court has
discussed the enablement or written description arguments
made by the Defendant when discussing the reverse doctrine
of equivalents.
Sonosite’s summary judgment evidence in support of its
contention that the reverse doctrine of equivalents applies in
this case does not address the patented device. Rather,”
Sonosite attempts to create a fact issue on the doctrine of
equivalents by comparing the accused devices to the language
of the patent application prior to its amendment and prior to
the issuance of the ‘021 patent. The Court finds, however,
that this analysis is against the weight of the authority on
this subject. Therefore, the Court declines to apply the reverse
doctrine of equivalents in this case. Sonosite has not met its
burden of establishing that the accused devices perform in a
substantially different manner from the patented claim.
29a
Appendix C
Conclusion
The Court finds that there is no evidence to support
Sonosite’s contention that the reverse doctrine of equivalents
should be applied in this case. Therefore, because Sonosite
does not raise a fact issue on the question of infringement,
and the Court declines to apply the doctrine based on the
facts presented by Defendant, Plaintiff's Motion for Summary
Judgment on Infringement (Dkt.# 136) is GRANTED.
It is so ORDERED.
30a
APPENDIX D— MEMORANDUM AND ORDER OF THE
UNITED STATES DISTRICT COURT FOR THE
SOUTHERN DISTRICT OF TEXAS, HOUSTON
DIVISION DATED SEPTEMBER 30, 2004
(Re: Defendant’s Post-Markman Motion
for Summary Judgment)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF TEXAS
HOUSTON DIVISION
No. CIV.A.H-01-2484
NEUTRINO DEVELOPMENT CORPORATION,
Plaintiff,
v.
SONOSITE, INC.,
Defendant.
Sept. 30, 2004.
MEMORANDUM AND ORDER
RAINEY, District Judge.
Pending before the Court is Defendant’s Post-Markman
Motion for Summary Judgment based on Invalidity (Dkt.#
131). The Court, after reviewing the motion, the responses
of the parties and the relevant law, is of the opinion that the
motion should be DENIED.
3la
Appendix D
Factual and Procedural Background
This is an action for patent infringement brought by
Neutrino Development Corporation (“Neutrino”) against
Sonosite, Inc. (“Sonosite”). Neutrino is the owner of United
States Patent No. 6,221,021 (“the ‘021 patent”). Neutrino
alleges that four devices manufactured and marketed by
Sonosite, the Sonosite 180, SonoHeart, Sonosite 180 PLUS,
and the SonoHeart PLUS, infringe on the ‘021 patent.
Richard T. Redano applied for a patent on the device in
question on September 9, 1997. (Application Serial No. 08/
926, 209).' The ‘021 patent, entitled “Method and Apparatus
for Penile Hemodynamic Stimulation, Monitoring, and Drug
Delivery Acceleration,” resulted from that application. It
describes a device for “stimulating and/or monitoring
hemodynamic activity, such as blood flow, in a penis.”
U.S. Patent No. 6,221,021 at col. 1, ll. 15-16.
Defendant Sonosite began as a division of ATL
Ultrasound, Inc., and was spun off as a public company in
April 1998. Sonosite unveiled its first public product in the
realm of hand-carried ultrasound devices, the Sonosite 180,
on May 17, 1999. Sonosite began selling the device in June
1999. In January 2000, Sonosite launched its second product,
the SonoHeart. In April 2001, Sonosite launched a new
generation of these two devices with its introduction of the
SonoSite 180 PLUS ‘nid the SonoHeart PLUS.
1. On May 20, 1999, Redano field a continuation in patent
application, serial No. 09/315,867 which eventually issued as the
‘021 patent. In May 2000, Redano amended the pending ‘021 Patent
Application to broaden its disclosure and expand the claims. The
‘021 patent was issued on April 24, 2001.
32a
Appendix D
On July 24, 2001, Neutrino filed this action, alleging
that Sonosite had illegally used Redano’s invention and
infringed the ‘021 patent. Sonosite answered the complaint
on August 14, 2001, asserting that the ‘021 patent claims are
not infringed and are invalid, and counterclaimed for
declaratory judgment of non-infringement and invalidity.
On February 20, 2002, after extensive briefing, the Court
held a one-day Markman hearing on claim construction. On
October 9, 2002, the Court stayed all proceedings pending
the Court’s Markman and summary judgment rulings. The
Court issued its claim construction on August 21, 2003. This
motion for summary judgment was filed as a result of the
Court’s claim construction.
Summary Judgment Standard
Summary judgment is proper if “the pleadings,
depositions, answers to interrogatories, and admissions on
file, together with the affidavits, if any, show that there is no
genuine issue as to any material fact and that the moving
party is entitled to a judgment as a matter of law.” Fed. R.
Civ. P. 56(c); see also Christopher Village, LP v. Retsinas,
190 F.3d 310, 314 (Sth Cir.1999). “For any matter on which
the non-movant would bear the burden of proof at trial... ,
the movant may merely point to the absence of evidence and
thereby shift to the non-movant the burden of demonstrating
by competent summary judgment proof that there is an issue
of material fact warranting trial.” Transamerica Ins. Co. v.
Avenell, 66 F.3d 715, 718-19 (Sth Cir.1995); see also Celotex
Corp. v. Catrett, 477 U.S. 317, 323-25, 106 S.Ct. 2548, 91
L.Ed.2d 265 (1986). To prevent summary judgment, the non-
33a
Appendix D
movant must “respond by setting forth specific facts” that
indicate a genuine issue of material fact. Rushing v. Kansas
City S. Ry. Co., 185 F.3d 496, 505 (Sth Cir.1999),.
When considering a motion for summary judgment, the
Court must view the evidence in the light most favorable to
the non-movant and draw all reasonable inferences in favor
of the non-movant. See Samuel v. Holmes, 138 F.3d 173,
176 (Sth Cir.1998); Texas v. Thompson, 70 F.3d 390, 392
(Sth Cir.1995). “The court may not undertake to evaluate the
credibility of the witnesses, weigh the evidence, or resolve
factual disputes; so long as the evidence in the record is such
that a reasonable jury drawing all inferences in favor of the
nonmoving party could arrive at a verdict in that party’s favor,
the court must deny the motion.” /nt’l Shortstop, Inc. v.
Rally’s, Inc., 939 F.2d 1257, 1263 (Sth Cir.1991). However,
the non-movant cannot avoid summary judgment by
presenting only “conclusory allegations,” or “unsubstantiated
assertions,” such as the bare allegations of a complaint, but
must present sufficient evidence, such as sworn testimony
in a deposition or affidavit, to create a genuine issue of
material fact as to the claim asserted. Little v. Liquid Air
Corp., 37 F.3d 1069, 1075 (Sth Cir.1994) (en banc).
Patent cases are amenable to summary judgment as any
other case when no genuine issue of material fact exists and
the movant is entitled to judgment as a matter of law. See
Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S.
17, 39, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997); Johnston v.
IVAC Corp., 885 F.2d 1574, 1576-77 (Fed.Cir.1989); SRI
Int’l v. Matsushita Elec. Corp. of Am.; 775 F.2d 1107, 1116
(Fed.Cir. 1985).
34a
Appendix D
Analysis
Defendant challenges the validity of the ‘021 patent by
asserting that the invention was on sale in the country more
than one year prior to the date of the patent and thus the
patent is invalid because it violates the on-sale bar of
35 U.S.C. § 102(b). Additionally, Defendant challenges the
validity of the patent by asserting that the claims of the patent
read on a prior art product, a Diasonics Ultrasound Model
Inpact VFI, also known as the Compact System (“Compact
System”), and is thus anticipated under 35 U.S.C. § 102(b).
Under 35 U.S.C. § 282, a patent is presumed valid and
an attack on its validity requires proof of facts by “clear and
convincing evidence or its equivalent, by whatever form of
words it may be expressed.” American Hoist & Derrick Co.
v. Sowa & Sons, 725 F.2d 1350, 1360 (Fed.Cir.), cert. denied,
469 U.S. 821, 105 S.Ct. 95, 83 L.Ed.2d 41 (1984). The “clear
and convincing” standard of proof of facts is an intermediate
standard which lies somewhere between “beyond a
reasonable doubt” and a “preponderance of the evidence.”
Addington v. Texas, 441 U.S. 418, 425, 99 S.Ct. 1804, 60
L.Ed.2d 323 (1979). Although not susceptible to precise
definition, “clear and convincing evidence” has been
described as evidence which produces in the mind of the
trier of fact “an abiding conviction that [the] truth of the
factual contentions are ‘highly probable.’ ” Colorado v. New
Mexico, 467 U.S. 310, 316, 104 S.Ct. 2433, 81 L.Ed.2d 247
(1984).
35a
Appendix D
- On-Sale Bar
Under § 102(b), “[a] person shall be entitled to a patent
unless . . . the invention was. . . on sale in this country, more
than one year prior to the date of the application for the patent
in the United States.” 35 U.S.C. § 102(b) (2000). A § 102(b)
determination is a conclusion of law based on underlying
findings of fact. Linear Tech. Corp. v. Micrel, Inc., 275 F.3d
1040, 1047 (Fed.Cir.2001). A two pronged test governs the
application of the on-sale bar: “First, the product must be
the subject of a commercial offer for sale ... Second, the
invention must be ready for patenting.” Pfaff v. Wells Elecs.,
Inc. , 525 U.S. 55, 67, 119 S.Ct. 304, 142 L.Ed.2d 261 (1998).
Sonosite’s motion for summary judgment focuses on the first
prong of this test.
Although the standard for determining what constitutes
an Offer to sell sufficient to raise the on sale bar had been
subject to come confusion, the Federal Circuit clarified the
standard in Group One Limited v. Hallmark Cards, 254 F.3d
1041 (Fed.Cir.2001). In Group One, the Federal Circuit held
that “[o]nly an offer which rises to the level of a commercial
offer for sale, one which the other party could make into
a binding contract by simple acceptance (assuming
consideration), constitutes an offer for sale under § 102(b).”
Id. at 1048 (concluding that the need for national uniformity
in patent law requires the application of federal common law).
To determine if the offer is sufficiently definite, one must
examine the language of the proposal in accordance with the
principles of general contract law. Jd. at 1048. Because this
issue is governed by federal common law, an important
relevant source of general contract law for determining
36a
Appendix D
whether a “communication or series of communications rises
to the level of a commercial offer for sale” is the Uniform
Commercial Code (“UCC”). Id. at 1047; see also Univ. of
Colo. Found., Inc., v. Am. Cyanamid Co., 196 F.3d 1366,
1372 (Fed.Cir.1999). Notably, an offer for sale does not have
to be accepted to implicate the on-sale bar. UMC Elecs. Co.
v. United States, 816 F.2d 647, 653 (Fed.Cir. 1987) (overruled
on other grounds by Pfaff, 525 U.S. 55, 119 S.Ct. 304, 142
L.Ed.2d 261 (1998)).
Sonosite asserts that a device embodying each claim of
the disputed patent was on sale prior to September 9, 1996,
the critical date for determining whether the on-sale bar
applies. Specifically, Sonosite asserts that Diasonics
Ultrasound Inc. (“Diasonics”) advertised and sold its Impact
VFI portable ultrasound imaging device, also known as the
Compact System (“Compact System”) prior to the critical
date. To support this contention, Sonosite relies on the
declaration of David Sherman, an employee of Sonosite who
was previously employed by Diasonics Ultrasound.
Sherman’ s declaration states that he was “personally involved
in the sales process for the Impact VFI portable ultrasound
smaging device, also known and marketed as the Compact
VFI and the Diasonics Compact System, which was sold by
Diasonics and manufactured by Ausonics Pty. Ltd.”
Declaration of David Sherman, attached to Sonosite's Motion
for Summary Judgment, para. 12. Sherman goes on to state
that “Diasonics first placed this device on sale in the United
States prior to April 1996.” Mr. Sherman also states that he
has reviewed the advertising literature (the Diasonics
brochure)and asserts that it was “printed in April 1996 and
that it was widely distributed to potential customers of the
device.” /d. at para. 13.
37a
Appendix D
The Federal Circuit, however, has made it clear that
“uncorroborated oral testimony, particularly that of interested
persons recalling long past events, does not, of itself, provide
the clear and convincing evidence required to invalidate a
patent . . .” Woodland Trust v. Flowertree Nursery, 148 F.3d
1368, 1369 (Fed.Cir. 1998).
As supporting documentation, Sonosite has provided a
copy of a brochure created by Diasonics, which describes
the Compact System. The only date information on the
brochure is a notation on the last page which reads “Diasonics
Ultrasound Pt. No. 925-00001-00 Rev C 4/96.” This is the
only possible corroboration on the document that suggests
that the device was on sale on or before April of 1996. This
evidence is not enough, however, to trigger the on sale bar.
See Lacks Indus., Inc. v. McKechnie Vehicle Components
USA, Inc., 322 F.3d 1335 (requiring a formal offer under
principles of contract law before the on-sale bar is
implicated). At best, this date corroborates Mr. Sherman’s
testimony that the brochure was printed in April of 1996.
Thus, the Court finds that Sonosite does not provide
sufficient evidence to corroborate Sherman’s testimony.
Rather, Sonosite asks the Court to draw inferences from a
date on a brochure and the testimony of an individual who
does not provide a date certain for Diasonics’s sale of the
Compact System, but rather testifies that it was on sale
“before April 1996.” The Court finds that this information,
without something more definite to show that the device was
actually on sale, fails to meet the clear and convincing
evidence standard necessary to trigger the on-sale bar.
See Intel Corp. v. U.S. Int’l Trade Comm’n, 946 F.2d 821
38a
Appendix D
(Fed.Cir. 1991) (holding that the Court would have to “engage
in extensive inference drawing to conclude” that the product
in question had actually been sold prior to the critical date
merely because protypes had been given to salesmen with
instructions to sell them).
Anticipation.
Sonosite further argues that the Diasonics device
anticipates every Claim of the ‘021 patent. Although the
question of whether a device was on-sale before the critical
date is a question of law determined by underlying factual
issues, anticipation is a question of fact. Compare Paragon
Podiatry Lab., Inc. v. KLM Labs., Inc., 984 F.2d 1182, 1186
(Fed.Cir.1993) (holding that the on sale bar was a question
of law amenable to summary judgment where there were no
underlying material facts in issue) with Advanced Display
Sys. Inc. v. Kent State Univ., 212 F.3d 1272, 1281
(Fed.Cir.2000) (holding that anticipation is a question of fact
(internal citation omitted)). To-make such a finding on
summary judgment, the Court must determine that no facts
material to the question are disputed; or that even if all
material factual inferences are drawn in favor of the non-
movant, there is no reasonable basis on which the non-movant
can prevail. Cooper v. Ford Motor Co., 748 F.2d 677, 679
(Fed.Cir. 1984).
Section 102(b) provides that “a person shall be entitled
to a patent unless the invention was patented or described in
a printed publication . . . more than onc year prior to the date
of publication.” 35 U.S.C. § 102(b) (2000). Accordingly,
invalidity by anticipation requires that the four corners of a
39a
Appendix D
single, prior art document describe every element of the
claimed invention, either expressly or inherently, such that a
person of ordinary skill in the art could produce the invention
without undue experimentation. See Atlas Powder Co. v.
Treco Inc., 190 F.3d 1342, 1347 (Fed.Cir.1999). Material not
explicitly contained in the single, prior art document may
still be considered for purposes of anticipation if that material
is incorporated by reference into the document. See Ultradent
Prods., Inc. v. Life-Like Cosmetics, Inc., 127 F.3d 1065, 1069
(Fed.Cir.1997) (holding that material incorporated by
reference into a document may be considered in an
anticipation determination). Additionally, extrinsic
information may be considered to explain the disclosure of
a reference. The role of extrinsic evidence is to educate the
decision-maker to what the reference meant to persons of
ordinary skill in the field of the invention, not to fill gaps in
the reference. See Studiengesellschaft Kohle, m.b.H. v. Dart
Indus., Inc., 726 F.2d 724, 727 (Fed.Cir.1984) (although
additional references may serve to reveal what a reference
would have meant to a person of ordinary skill, it is error to
build “anticipation” on a combination of these references).
If it is necessary to reach beyond the boundaries of a single
reference to provide missing disclosure of the claimed
invention, the proper ground is not § 102 anticipation, but §
103 obviousness. Scripps Clinic and Research Found. vy.
Genentech, Inc., 927 F.2d 1565, 1577 (Fed.Cir.1991).
Evaluating an anticipation claim requires a two step
analysis. The first step of an anticipation analysis is claim
construction. See Key Pharms. v. Hercon Labs. Corp., 161
F.3d 709, 714 (Fed.Cir.1998). The Court, after hearing
evidence and testimony at a Markman hearing, issued its
40a
Appendix D
claim construction on August 20, 2003. In its order, the Court
construed the ‘021 patent as follows:
1. “A transducer mounting assembly moveably
connected to said body such that the distance between said
assembly and said body can be adjusted by a user using only
one hand”-An assembly sized to contain at least one
ultrasound emitter or transducer, which is connected to the
portable body such that a user of the apparatus can cause a
change in the distance between the transducer mounting
assembly and the portable body, using only one hand.
2. “A portable body sized to be hand held”-A body that
is sized such that it can be held by hand and, so held, moved
from one location to another.-
3. “Ultrasound emitter”-At least one component, also
known as a “transducer” or “emitter,” and capable of emitting
ultrasound energy.’
The second step of the analysis involves a comparison
of the construed claim to the prior art. See Key Pharms., 161
F.3d at 714. To be anticipating, a prior art reference must
disclose “each and every limitation of the claimed
invention{,] . . . must be enabling[,] and [must] describe . . .
{the]claimed invention sufficiently to have placed it in
possession of a person of ordinary skill in the field of the
2. The Court held that the following terms did not need to be
interpreted because they were unambiguous: |) “mounted in,”
“mounted on,” “housed within,” and “top surface,” 2) “portable body
comprising a top surface;” 3) “connected to” and “coupled to;”
4) “generating an instruction,” and 5) “display.”
4la
Appendix D
invention.” Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339, 1346
(Fed.Cir.2000)(quoting Jn re Paulsen, 30 F.3d 1475, 1478-
79 (Fed.Cir.1994)). If there is a genuine issue of material
fact relevant to any one of these factors, summary judgment
is not proper. Id.
Sonosite’s motion for summary judgment argues that the
Diasonics device discloses each of the limitations of claims
8, 11, 12, 13, 20, 21, and 23-27 of the ‘021 patent as construed
by the Court. To support this contention, Sonosite attached
as exhibits the Diasonics brochure, the declaration of David
Sherman, the declaration of Robert Isackson, and a transcript
of the testimony of Jens Quistgaard from the Markman
hearing. Sonosite also attached a “detailed claims chart”
outlining the ways in which the Diasonics device anticipates
each claim of the patented device. See Sonosite’s Motion for
Summary Judgment, Exhibit 1.
Neutrino objects to these supporting documents as being
hearsay, uncorroborated, lacking in foundation, speculation,
and wholly based on interested testimony. With regard to
the declarations of Isackson, Sherman and Quistgaard and
the testimony of Quistgaard from the Markman hearing,
Neutrino also objects that they are providing expert opinions
without having been designated as experts. First, with respect
to the Diasonics brochure, Neutrino questions its authenticity
as well as arguing that it contains hearsay and that it is
uncorroborated. The Court ruled on this same issue in an
order dated September 24, 2002. In that order, the Court held
that the brochure was noi hearsay because it is a legally
operative document. See Court’s Order on Plaintiff
Neutrino’s Motion to Strike Inadmissible Exhibits (Dkt.# 122)
42a
Appendix D
(citing Stuart v. UNUM Life Ins. Co. of Am., 217 F.3d 1145,
1154 (9th Cir.2000)). The Court also held that the document
“need only be authenticated to be admissible.” /d. citing
Kepner-Tregoe, Inc. v. Leadership Software, Inc., 12 F.3d
527, 540 (Sth Cir.1994). In the Court’s opinion, the
declaration of David Sherman authenticates the brochure
when he states that he has reviewed the advertising literature
(the Diasonics brochure) and can “confirm that it accurately
depicts the Diasonics Impact VFI device,” and “that it was
printed in April 1996. . .”” See Declaration of David Sherman,
attached to Sonosite’s Post-Markman Motion for Summary
Judgment based on Invalidity, para. 12. Second, with regard
to the “claims chart,” Neutrino objects that the chart is
uncorroborated and wholly based on interested testimony.
The Court notes, however, that Neutrino provides a chart of
its own to detail how and why the claims are not anticipated
by the Diasonics device. Although Neutrino’s chart is
different from Sonosite’s in that Nevtrino’s chart contains
references to both interested and purportedly uninterested
testimony, this is a credibility determination to be made by
the finder of fact, not the Court. Finally, with respect to the
declarations of Isackson, Sherman and Quistgaard, and the
Quistgaard testimony, Neutrino objects that these statements
offer expert opinions although the individuals giving them
have not been designated as experts. The Court finds these
to be substantially similar to the declarations of Douglas Beall
and Richard Redano, which are attached to Neutrino’s
response to the Motion for Summary Judgment and are used
by Neutrino to support its contention that the patent is not
invalid. Although the Court notes that neither side has
designated experts, the Court also notes that neither side is
preciuded from submitting the opinions of lay witnesses, so
—_,
-_
43a
Appendix D
long as those opinions are limited to “those opinions which
are (a) rationally based on the perception of the witness;
(b) helpful to a clear understanding of the witness’ testimony
or the determination of a fact in issue, and (c) not based on
scientific, technical, or other specialized knowledge within
the scope of Rule 702.” Fed.R.Evid. 701. To the extent that
any of the declarations or transcript testimony rises to the
level of expert testimony, the Court will disregard those
portions of the declarations or transcript testimony. The
majority of the declarations’ contents, however, are
admissible as perceptions of the witnesses or as being helpful
to a clear understanding of the witnesses’ testimony and the
determination of a fact in issue. Therefore, the Court wiil
allow the- declarations to be used as summary judgment
evidence.
Having reviewed all of the documentation discussed
above, the Court believes that a fact issue exists on the issue
of anticipation. The Court cannot reconcile the testimony of
Dr. Quistgaard with that of Dr. Beall. Dr. Quistgaard’s
testimony, coupled with that of Mr. Sherman, is that the
Diasonics device anticipates each claim of the ‘021 patent.
Dr. Beall, on the other hand, asserts that the Diasoncs device
does not anticipate any of the claims of the ‘021 patent. For
example, with regard to the claim that the device contain “a
body that is sized such that it can be held by hand, and so
held, moved from one location to another,” Dr. Quistgaard
testified that the Diasonics device was capable of being
picked up by someone such as himself and moved from one
location to another. See Testimony of Jens Quistgaard,
attached as Exhibit R to the Declaration of Robert Isackson,
page 14, lines 8-10. Thus, Dr. Quistgaard believes that the
44a
Appendix D
claims relating to the device being hand-held are anticipated
by the Diasonics device. Dr. Beall’s declaration states,
however, that from his review of the Diasonics literature and
his observations of the device, the Diasonics device would
be too large and too heavy for someone such as himself to
hold the body of the device by hand and move it from one
location to another. See Declaration of Douglas Beall
attached to Plaintiff ’s Response to the Motion for Summary
Judgment, page 4, paragraph 9 & 10. Thus, Dr. Beall believes
that the Diasonics device does not anticipate the hand-held
portions of the ‘021 patent. The portability of the device is
an issue that occurs in independent claim numbers 8, 20,
and 25. The parties’ witnesses have equally competing views
on issues relating to the transducers, the ability of an operator
of the Diasonics device to change the distance between the
transducer mounting assembly and the portable body using
only one hand, and whether the Diasonics device actually
contains “at least two ultrasound emitters” as required by
the ‘021 patent. Thus, the Court is faced with conflicting
testimony regarding virtually every aspect of the ‘021 patent.
Whether the Diasonics device anticipates each of the claims
in the pateni, based on the observations of the parties’
competing witnesses, is a question for the trier of fact, rather
than the Cowrt. 6 decide. Therefore, the Court finds that
summary judgment is inappropriate.
ites
45a
Appendix D
Conclusion
The Court finds that there are fact issues surrounding
the on-sale bar and the issue of anticipation. Therefore,
Defendant’s Post-Markman Motion for Summary Judgment
based on Invalidity (Dkt. # 131) is DENIED.
It is so ORDERED.
46a
APPENDIX E — OPINION OF THE UNITED
STATES DISTRICT COURT FOR THE SOUTHERN
DISTRICT OF TEXAS, HOUSTON DIVISION
DATED JANUARY 23, 2006
UNITED STATES DISTRICT COURT
S.D. TEXAS
HOUSTON DIVISION
No. CIV.A. H-01-2484.
Jan, 23, 2006.
NEUTRINO DEVELOPMENT CORPORATION,
Plaintiff,
V.
SONOSITE, INC.,
Defendant.
MEMORANDUM AND ORDER
RAINEY, District Judge.
Pending before the Court are Neutrino Development
Corporation’s (“Neutrino”) Motion to Exclude Testimony of
Defendant SonoSite’s Expert Witness Joan Baker (Dkt.
# 258), Neutrino’s Motion to Exclude Testimony of
Defendant SonoSite’s Expert Witness Donald W. Baker
(Dkt.# 259), Neutrino’s Motion to Exclude Testimony of
Defendant SonoSite’s Expert Witness Dr. Don L..
47a
Appendix E
Berardinucci (Dkt.# 260), Neutrino’s Motion to Exclude
Testimony of Defendant SonoSite’s Expert Witness Cameron
Weiffenbach (Dkt.# 261), Neutrino’s Motion to Exclude
Testimony of Defendant SonoSite’s Expert Witness Jens U.
Quistgaard (Dkt.# 262), Neutrino’s Motion to Exclude
Testimony of Defendant SonoSile’s Expert Witness Jens U.
Quistgaard on Lack of Infringement by SonoSite’s Products
(Dkt.# 266), Neutrino’s Motion to Exclude Testimony of
Defendant SonoSite’s Expert Witness Lauren S. Pflugrath
(Dkt.# 267), and Neutrino’s Motion to Exclude, or In Limine,
the Testimony of Stephen M. Graham (Dkt. # 343). The
Court, having reviewed the motions, the responses of the
parties, and the applicable law, is of the opinion that
Plaintiff's motions (Dkt.4#258, 267, and 343) should be
DENIED, Plaintiff’s motion (Dkt.# 260) should be
GRANTED, and Plaintiff's motions (Dkt.#259, 261, 262,
and 266) should be GRANTED in part and DENIED in part.
Factual and Procedural Background
This is an action for patent infringement brought by
Neutrino Development Corporation (“Neutrino”) against
Sonosite, Inc. (“Sonosite”). Neutrino is the owner of United
States Patent No. 6,221,021 (“the ‘021 patent”). Neutrino
alleges that four devices manufactured and marketed by
Sonosite, the Sonosite 180, SonoHeart, Sonosite 180 PLUS,
and the SonoHeart PLUS, infringe on the ‘021 patent.
Richard T. Redano applied for a patent on the device in
qucstion on September 9, 1997. (Application Serial No. 08/
926, 209). The ‘021 patent, entitled “Method and Apparatus
for Penile Hemodynamic Stimulation, Monitoring, and Drug
48a
Appendix E
Delivery Acceleration,” resulted from that application.
It describes a device for “stimulating and/or monitoring
hemodynamic activity, such as blood flow, in a penis.”
U.S. Patent No. 6,221,021] at col. 1, ll. 15-16.
Defendant Sonosite began as a division of ATL
Ultrasound, Inc., and was spun off as a public company in
April 1998. Sonosite unveiled its first public product in the
realm of hand-carried ultrasound devices, the Sonosite 180,
on May 17, 1999. Sonosite began selling the device in June
1999. In January 2000, Sonosite launched its second product,
the SonoHeart. In April 2001, Sonosite launched a new
generation of these two devices with its introduction of the
SonoSite 180 PLUS and the SonoHeart PLUS.
On July 24, 2001, Neutrino filed this action, alleging
that Sonosite had illegally used Redano’s invention and
infringed the ‘021 patent. Sonosite answered the complaint
on August 14, 2001, asserting that the ‘021 patent claims are
not infringed and are invalid, and counterclaimed for
declaratory judgment of non-infringement and invalidity.
On February 20, 2002, after extensive briefing, the Court
held a one-day Markman hearing on claim construction. On
October 9, 2002, the Court stayed all proceedings pending
the Court’s Markman and summary judgment rulings. The
Court issued its claim construction on August 21, 2003.
Subsequently, the Court granted Neutrino’s Motion for
Summary Judgment on Infringement (Dkt.# 136) finding that
Sonosite’s devices literally infringed the ‘021 patent and the
reverse doctrine of equivalents was not applicable (Dkt.#
162). Consequently, Sonosite’s case for trial focuses on the
49a
Appendix E
invalidity of the ‘021 patent, which requires expert testimony
about the ‘021 patent and certain prior art. Neutrino has
objected to the testimony of the above-named seven Sonosite
experts.
Expert Testimony Standard
Federal Rule of Evidence 702 provides:
If scientific, technical, or other specialized
knowledge will assist the trier of fact to
understand the evidence or to determine a fact in
issue, a witness qualified as an expert by
knowledge, skill, experience, training, or
education, may testify thereto in the form of an
opinion or otherwise, if (1) the testimony is based
upon sufficient facts or data, (2) the testimony is
the product of reliable principles and methods,
and (3) the witness has applied the principles and
methods reliably to the facts of the case.
This “imposes 4 special obligation upon a trial judge to
‘ensure that any and all scientific testimony’ .. . is not only
relevant, but reliable.” Kumho Tire Co., Ltd. v. Carmichael,
526 U.S. 137, 147, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999)
(quoting Daubert v. Merrell Dow Pharms., Inc., 509 U.S.
579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993)). The
expert testimony must be relevant, not simply in the sense
that all testimony must be relevant under Federal Rule of
Evidence 402, but also in the sense that the expert’s proposed
opinion is based on a valid scientific inquiry. Daubert, 509
U.S. at 592, 113 S.Ct. 2786.
cemented
50a
Appendix E
The Supreme Court has provided five non-exclusive
factors to consider when assessing whether the methodology
upon which an expert rests his opinion is scientifically
reliable. These factors are (1) whether the expert's theory
can be or has been tested, (2) whether the theory has been
subject to peer review and publication, (3) the known or
potential rate of error of a technique or theory when applied,
(4) the existence and maintenance of standards and controls,
and (5) the degree to which the technique or theory has been
generally accepted in the scientific community. Daubert, 509
U.S. at 593-94, 113 S.Ct. 2786; Burleson v. Texas Dept. of
Criminal Justice, 393 F.3d 577 (Sth Cir.2004). The test for
determining reliability is flexible and can adapt to the
particular circumstances underlying the testimony at issue.
Kumho Tire, 526 U.S. at 150-51, 119 S.Ct. 1167. The party
seeking to have the district court admit expert testimony must
demonstrate by a preponderance of the evidence that the
expert’s findings and conclusions are reliable, but need not
show that the expert’s findings and conclusions are correct.
Moore v. Ashland Chem., Inc., 151 F.3d 269, 276 (Sth
Cir.1998),
Discussion
I. Joan Baker
Ms. Baker’s testimony pertains to whether certain
amendments made to the ‘021 patent specification constituted
a “new matter” and were therefore improperly included under
the patent.' For such an amendment to be properly included
1. See Sonosite’s Exhibit 12. Amendments made via letter of
May 4, 2000 and letter of November 14, 2000.
Sla
Appendix E
it must be inherently supported in the original patent
application. 35 U.S.C. § 132. That is, a person of ordinary
skill in the art could have looked at the patent application as
of the filing date and determined that the claimed invention
included the later-claimed subject matter. TurboCare Div. of
Demag Delaval Turbomach. Corp. v. Gen. Elec. Co., 264
F.3d 1111, 1118-19 (Fed.Cir.2001). Neutrino objects to Ms.
Baker’s testimony on three grounds: (1) Ms. Baker is not
qualified to give expert opinions on the “ordinary level of
skill in the art” for the ‘021 patent; (2) Ms. Baker has failed
to determine what “one of ordinary skill in the art” would
recognize from the initial disclosures of the ‘021 patent; and
(3) Ms. Baker’s opinions are conclusory and are not supported
by any of the reliability factors recognized under Daubert.*
Sonosite opposes Neutrino’s contention that Ms. Baker’s
qualifications are wanting on the grounds that she is a
“pioneer” in the field of medical ultrasound and has extensive
experience with the use and operation of diagnostic medical
ultrasound devices.’ The Court acknowledges that Ms.
Baker’s resume and professional experience support
Sonosite’s characterization of her qualifications. However,
Ms. Baker’s qualifications must allow her to offer opinions
from the perspective of “one of ordinary skill in the art.”
The appropriate level of ordinary skill in the art is a complex
factual inquiry within an abstract legal standard. Ryko Mfg.
Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed.Cir.1991).
Although the finder of fact will ultimately decide the level
— oe ee
2. Dkt. # 258, p. 2.
3. Dkt. # 300, at 1-4.
52a
Appendix E
of ordinary skill in the art, the Court must determine the
relevant art area as a matter of law in order to determine
whether particular experts are qualified under Daubert.
Courts have long acknowledged the difficulty of this task.
Judge Learned Hand, writing for the Second Circuit Court
of Appeals before the regional appellate courts were rescued
from such matters in 1982, quipped that, “[w]hen all is said,
we are called upon imaginatively to project this act of
discovery against an hypostatized average practitioner,
acquainted with all that has been published and all that has
been publicly sold. If there be an issue more troublesome, or
more apt for litigation than this, we are not aware of it.”
Harries v. Air King Products Co., 183 F.2d 158, 162 (2d
Cir.1950).
The “new matter” defense at bar requires the hypothetical
person of ordinary skill in the art to be able to construe the
‘O21 patent application and thereby understand what
comprises the claimed invention. The specific issue at bar is
whether the hand-held nature of the ultrasonography
generator claimed in the amendment was inherent in the
original patent application. The Court finds that the relevant
art area for making this determination is the “designing,
testing and building” of medical ultrasound devices.* The
law does not require an expert opining from the perspective
of “one of ordinary skill in the art” to have the same
qualifications as the inventor or even be an inventor herself.
See Orthopedic Equip. Co. v. All Orthopedic Appliances, 707
F.2d 1376, 1382 (Fed.Cir.1983). But it does require that she
is sufficiently qualified to construe the patent and understand
4. Sonosite’s Exhibit 10. This formulation of the relevant art
area clarifies the Court's broader formulation in Dkt. # 325, p. 6.
53a
Appenaix E
the design and components of the claimed invention as one
with ordinary skill in the art of designing, testing, and
building medical ultrasound devices.
Ms. Baker’s report and curriculum vitae establish that
her qualifications are in the relevant art area. Ms. Baker’s
experience consulting on the design features of prototype
medical ultrasound devices and considering the ergonomic
aspects of medical ultrasound devices qualify her to opine
about what design features would be inherently understood
from the description of the ultrasonography generator in the
original patent application.® The ability of a user to hold a
component of the device in his hand is specifically an
ergonomic issue. Whether such an ergonomic feature is
inherently described in the original patent application is
something about which Ms. Baker is qualified to testify under
Daubert.
Neutrino also challenges Ms. Baker’s testimony on the
grounds that she has not properly resolved the skill level of
one of “ordinary skill in the art.” Neutrino argues that,
because Ms. Baker has failed to determine the level of
ordinary skill in the art, her opinions are irrelevant because
they are not offered from the legally requisite perspective.
“In determining [the level of ordinary skill in the art], the
[trier of fact] may consider various factors including ‘type
of problems encountered in the art; prior art solutions to those
problems; rapidity with which innovations are made;
sophistication of the technology; and educational level of
active workers in the field.’” Jn re GPAC Inc., 57 F.3d 1573,
4, Sonosite’s Exhibit 12, pp. 1-3.
54a
Appendix E
1579 (Fed.Cir.1995) (quoting Custom Accessories, Inc. v.
Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962-63
(Fed.Cir.1986)). Neutrino objects to Ms. Baker’s failure to
establish the level of skill she applied to her analysis through
the investigation of these factors. In order for Ms. Baker’s
testimony to be relevant to the issue of “new matter,” Sonosite
must establish that she has knowledge of the level of ordinary
skill in the art and that she has applied that perspective to
her testimony. Any disagreement between the parties about
what constitutes the level of ordinary skill would present a
fact issue to be resolved by the jury. However, Neutrino
claims that Ms. Baker has failed to offer any factual basis -
that could be evaluated by the jury.® The Court disagrees. In
her deposition, Ms. Baker testified that she considered the
level of ordinary skill in the art to be a person who “has been
trained and passed one’s credentialing examinations . . .”’
This statement is sufficient to allow the jury to determine
whether this is the appropriate level of ordinary skill in art.
Neutrino’s disagreement with Ms. Baker’s formulation of
the level of ordinary skill goes to the weight of her testimony,
not to its admissibility.
Finally, Neutrino objects to the reliability of Ms. Baker’s
testimony on the grounds that (1) she failed to consider all
the patents incorporated by reference in the ‘021 patent,
(2) she did not understand the terms “ultrasound generator”
and “ultrasonography generator,” (3) she only considered one
embodiment of the Pohl patent, and (4) she incorrectly
concludes that it would require 4 hands to operate the device
6. Dkt. # 258, pp. 4-6.
7. Sonosite’s Exhibit 15, at 59.
55a
Appendix E
described in the ‘021 patent. Neutrino’s allegation that
Ms. Baker failed to consider all of the patents incorporated
by reference in the ‘021 patent is based on her admission
that she did not use United States Patent No. 5,565,466
disclosed to Gioco et al. (“the ‘466 patent”) in preparing her
report.* Neutrino argues that this admitted omission renders
her evaluation of the ‘021 patent incomplete and therefore
unreliable under Daubert. Materials incorporated by
reference in a patent are effectively part of the patent as
though they were explicitly included in their entirety within
the patent document. Adv. Display Sys., Inc. v. Kent State
Univ., 212 F.3d 1272, 1282 (Fed.Cir.2000). Ambiguous terms
within the patent can sometimes be interpreted in light of
disclosures made in the materials incorporated by reference.
The “new matter” issue relevant to Ms. Baker’s testimony
focuses on the ambiguity of the term “ultrasonography
generator” in the ‘021 patent. Proper evaluation of that term
would require Ms. Baker to interpret it in light of disclosures
made in the patents incorporated by reference in the ‘021
patent. Ms. Baker explains in her deposition testimony that
she did not consider the ‘466 patent and did not include it
with her report because its disclosures were irrelevant to
opinions about the size of the ultrasonography generator in
the ‘021 patent. The ‘466 patent discloses a method for
enhancing sexual stimulation by introducing a vasodilator
agent into circulation to improve blood flow to the genital
region. The ‘466 patent does not involve or discuss medical
ultrasound devices or disclose any information that could
have informed Ms. Baker’s conclusions about the size of the
ultrasonography generator described in the ‘021 patent.
8. Dkt. # 258, at 15.
56a
Appendix E
Therefore, the Court finds that Ms. Baker’s exclusion of the
‘466 patent from her report was appropriate under the
circumstances and does not compromise the reliability of her
cima
Neutrino also argues that Ms. Baker admitted in her
deposition testimony that she did not understand the terms
“ultrasound generator” and “ultrasonography generator” and
therefore her testimony about the meaning of these terms is
uninformed and unreliable.’ Ms. Baker explained in her report
that the “terms ‘Ultrasonography Generator’ and ‘Ultrasound
Generator’ are not terms typically used in the field of
ultrasound, and have no special meaning.”'® Similarly,
Ms. Baker’s subsequent deposition testimony that she could
not be sure what Mr. Redano meant by those terms in the
‘021 patent simply indicated that those terms did not have
meaning in common usage independent of the ‘021 patent.
Nothing in Ms. Baker’s report or deposition testimony
indicates that her understanding of the those terms was
deficient. Ms. Baker’s specific understanding of the meaning
of those terms is a matter ripe for cross-examination.
Neutrino also challenges Ms. Baker’s testimony on the
grounds that her report only considered one embodiment of
United States Patent No. 5,578,060 disclosed to Pohl et al.
(“Pohl patent”). Neutrino has taken the position that the
original ‘901 patent application inherently disclosed a
portable, hand-held ultrasonography generator by
9. Id. at 16.
10. Sonosite’s Exhibit 12, p. 4.
57a
Appendix E
incorporating by reference the Pohl patent. Ms. Baker
concluded in her report that the Poh! patent did not describe
a hand-held device.'' Neutrino challenges the reliability of
Ms. Baker’s conclusion on the grounds that she failed to
evaluate the entirety of the Pohl patent. Sonosite argues that
Neutrino’s challenge goes to the weight of Ms. Baker’s
testimony, not to its admissibility. The Court agrees. The
reliability inquiry under Daubert asks the Court to consider
the methodology the expert employed to reach her
conclusion, not the accuracy of the conclusion itself. Moore
v. Ashland Chem., Inc., 151 F.3d 269, 276 (Sth Cir.1998).
Ms. Baker’s report discusses several aspects of the Pohl
patent and specifically considers Mr. Redano’s claims about
the Pohl patent. Neutrino presents no evidence that
Ms. Baker’s evaluation of the Pohl patent was deficient for
purposes of determining whether or not that patent disclosed
a hand-held component equivalent to the ultrasonography
generator in the ‘901 and ‘021 patent applications. Sonosite
Suggests, and the Court agrees, that the accuracy of
Ms. Baker’s conclusions about the Pohl patent are a matter
ripe for cross-examination and not appropriate grounds for
exclusion.
Finally, Neutrino challenges the reliability of Ms. Baker’s
testimony on the grounds that her report improperly
concludes that four hands would be required to operate the
device disclosed in the ‘021 patent. Neutrino objects to Ms.
Baker’s reliance on “the originally filed application from
which the ‘021 Patent claims priority.”'? Neutrino contends
11. Jd. at 8-10.
12. Dkt. # 258, at 20.
58a
Appendix E
that the appropriate focus should have been the “invention,”
which it defines as “the claims of the patent.’”'* However,
the Federal Circuit has explained that “[t}he written
description requirement and its corollary, the new matter
prohibition of 35 U.S.C. § 132, both serve to ensure that the
patent applicant was in full possession of the claimed subject
matter on the application filing date.” TurboCare, 264 F.3d
at 1118. New claims and any other added material must find
Support in the original specification. Therefore, the Court
finds that Ms. Baker properly focused her “new matter”
analysis on the specification in the original patent application.
As for Neutrino’s disagreement with Ms. Baker over the
numbers of hands required to hold different components and
turn different knobs, the Court finds that such a factual
controversy is more appropriate for cross-examination.
Therefore, the Court finds that Ms. Baker’s testimony is
admissible under Daubert.
II. Donald W. Baker
Mr. Baker’s testimony pertains to whether the ‘021 patent
would have enabled a person of ordinary skill in the art at
the time the patent application was filed to make and use the
claimed invention without undue experimentation. 35 U.S.C.
§ 112; Adang v. Fischhoff, 286 F.3d 1346, 1355
(Fed.Cir.2002); In re Wands, 858 F.2d 731, 737
(Fed.Cir. 1988). Neutrino objects to Mr. Baker’s testimony
on five grounds: (1) Mr. Baker’s underlying expertise was
out-dated at the time the ‘021 patent was filed; (2) Mr. Baker
13. Id. at 21.
59a
Appendix E
has demonstrated no knowledge of the level of ordinary skill
in the art; (3) Mr. Baker’s “real world feasibility” testimony
is irrelevant and unreliable; (4) Mr. Baker failed to
exclusively focus on the claims of the ‘021 patent; and (5)
Mr. Baker failed to properly consider the patents incorporated
by reference in the ‘021 patent.
Neutrino challenges Mr. Baker’s qualifications to testify
from the perspective of one of ordinary skill in the art at the
time the patent application was filed on the grounds that he
had been retired from the field for 12 years at the time of the
filing in 1997. Mr. Baker’s curriculum vitae confirms that
he held his last professional position in the field in 1983.
Furthermore, during his deposition, Mr. Baker conceded that
“many advances” in medical ultrasound technology and in
the miniaturization of electronic components used in
commercial products had taken place in the 12-year period
between his last professional position in the field and the
date the ‘021 patent was filed.'* Sonosite contends that
Mr. Baker remained current in the field through teaching,
consulting, and reading professional journals and was thereby
knowledgeable about the level of ordinary skill in the art in
1997. Sonosite further argues that Mr. Baker’s retirement
from the field is not sufficient to disqualify him as an expert.
The Court agrees that the simple fact that Mr. Baker was
retired in 1997 does not, in and of itself, disqualify his
testimony; however, the relevant inquiry under the
enablement defense requires Mr. Baker’s knowledge to be
contemporary to the patent application filing. Mr. Baker
testifies in his supplemental declaration that he kept abreast
14. Dkt. # 259, Exhibit B, p. 71.
60a
Appendix E
of developments in the field through consulting, teaching
and various other activities from the time of his retirement
through the time of the filing date of the ‘021 patent
application.'> Mr. Baker also explicitly qualifies his
explanation of the level of skill in the art in terms of his
knowledge of the field in 1997. Thus, the Court finds that
Mr. Baker’s knowledge of the field was not out-dated in 1997.
Any objections that Neutrino maintains about Mr. Baker’s
specific consideration of issues relevant to the field in 1997
are appropriate material for cross-examination.
Neutrino also objects generally to the sufficiency of
Mr. Baker’s knowledge of the level of ordinary skill in the
art in 1997. Neutrino’s assertion that Mr. Baker “has no idea
how to legally determine the level [of ordinary skil! in the
art]. . .” (emphasis added) misapprehends the proper inquiry
into the level of ordinary skill in the art. The relevant analysis
is factual. Ryko Mfg., 950 F.2d at 718. Mr. Baker’s factual
conclusions about the level of ordinary skill in the art are
under the purview of the jury so long as the Court determines
that his testimony is reliable. Neutrino contends that the
absence of analysis underlying Mr. Baker’s factual
conclusions about the level of ordinary skill fails the
reliability analysis set forth under Daubert. However,
Mr. Baker’s conclusivns about the level of ordinary skill in
the art are nonscientific expert opinions based on specialized
knowledge. See MCCORMICK ON EVIDENCE § 13. Where
scientific knowledge is not at issue, the Court need not use
the Daubert factors to determine reliability, but may gauge
reliability from a more flexible analysis. Kumho Tire, 526
15. Sonosite’s Exhibit 31.
6la
Appendix E
U.S. at 149, 119 S.Ct. 1167. Mr. Baker’s opinions as to the
level of ordinary skill in the art are necessarily based on his
own experience. In his supplemental declaration, Mr. Baker
sets forth the education and experience necessary to be one
of ordinary skill in the art and explains that he derived these
standards fromm his own experience working and teaching in
the field.'© The Court is satisfied that Mr. Baker has ample
experience in the field to reliably opine about the level of
ordinary skill in the art.
Neutrino also argues that Mr. Baker’s “real-world
feasibility” testimony is not relevant because it “is not a
correct focus in an enablement analysis.”'’ The Federal
Circuit Court of Appeals has articulated the test for
enablement as follows:
A decision on the issue of enablement requires
determination of whether a person skilled in the
pertinent art, using the knowledge available to
such a person and the disclosure in the patent
document, could make and use the invention
without undue experimentation.
Northern Telecom, Inc. v. Datapoint Corp., 908 F.2d 931,
941 (Fed.Cir. 1990). Neutrino contends that testimony by Mr.
Baker about the “feasibility” of designing the patented
invention subjects the patent to a more rigorous analysis than
that demanded by the “make and use ... without undue
experimentation” requirement of § 112. Specifically,
16.. Id.
17. Dkt. # 258, p. 13.
62a
Appendix E
Neutrino offers portions of Mr. Baker’s deposition testimony
that suggest Mr. Baker equated “feasibility” with commercial
success.'* The Federal Circuit has made clear that the
requirements of § 112 do not require evidence that the
patented device could be manufactured commercially. See
Christianson v. Colt Indus. Operating Corp., 822 F.2d 1544,
1562 (Fed.Cir.1987). Sonosite contends that Mr. Baker’s
opinions are relevant because they (1) “are expressed from
the appropriate point of view (ordinary skill in the art),” and
(2) “address the appropriate inquiry (undue
experimentation).” Sonosite suggests that Mr. Baker’s use
of the term “feasibility” was essentially short hand for the
factors the Federal Circuit has stated a court may consider in
determining whether a disclosure would require undue
experimentation.” It appears from Mr. Baker’s report that
he used the terms “feasibility” and “enablement” more or
less interchangeably. In his deposition testimony, Mr. Baker
concedes that he used the term “feasibility” to mean the
18. Id. at 14.
19. Factors:
~ (1) the quantity of experimentation necessary, (2) the
amount of direction or guidance presented, (3) the
presence or absence of working examples, (4) the nature
of the invention, (5) the state of the prior art, (6) the
relative skill of those in the art, (7) the predictability or
unpredictability of the art, and (8) the breadth of the
claims.
Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1371
(Fed.Cir.1999) (quoting Jn re Wands, 858 F.2d 731, 737
(Fed.Cir.1988)).
63a
Appendix E
ability of one of ordinary skill in the art to make and use a
“commercially acceptable product.” In fact, Mr. Baker
responded affirmatively to a deposition question about
whether the prototype he considered would be “a final.
package ready for commercialization. . . .” “Title 35 does not
require that a patent disclosure enable une of ordinary skill
in the art to make and use a perfected, commercially viable
embodiment absent a claim limitation to that effect.” CFMT,
Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1338
(Fed.Cir.2003). Because Mr. Baker’s analysis is based on a
standard inapplicable to the proper inquiry under § 112, his
testimony cannot assist the jury to resolve any fact relevant
to Sonosite’s enablement defense. The research and
development model set forth in Mr. Baker’s report simply
answers the wrong question and, as such, is inadmissible
under Federal Rule of Civil Procedure 402.
Thus, the Court finds that Mr. Baker may properly testify
as to the ordinary level of skill in the art at the time of the
‘021 patent filing, but cannot testify as to enablement under
§ 112 based on the analysis contained in his report.
III. Don L. Berardinucci
Neutrino objects to the testimony of Dr. Berardinucci
on the grounds that it is both irrelevant and unreliable.
Neutrino’s relevancy objection focuses on the contentions
that Dr. Berardinucci’s qualifications as a urologist are not
relevant to his testimony about the utility of the patented
device and his analysis focuses exclusively on one method
contained in the ‘021 patent description that need not be
64a
Appendix E
practicable for the ‘021 patent to be useful under 35 U.S.C.
§ 101.
Sonosite argues in response to Neutrino’s relevancy
objections that Dr. Berardinucci’s testimony is not offered
to establish a utility defense under § 101, but to suggest a
lack of enablement under § 112. It appears that the confusion
stems from Dr. Berardinucci’s use of the term “operability”
instead of “utility” or “enablement.” However, Neutrino also
contends that Dr. Berardinucci’s opinions about whether “the
device described and claimed in the ‘021 patent ‘would cure
erectile dysfunction by applying ultrasound energy to the
penis in order to stimulate blood flow’ "” are not relevant to
any issue at bar. To support this contention, Neutrino
advances a theory of patent construction that appears in
various Neutrino pleadings dealing with the enablement
defense. Essentially, Neutrino argues that the claims of the
‘021 patent do not describe a therapeutic device intended to
stimulate blood flow in the penis in order to accelerate drug
delivery to that region. Neutrino points out in other pleadings
and deposition questioning that the claims of the ‘021 patent
do not mention a penis or anything at all about erectile
dysfunction, stimulating blood flow, or drug delivery.
The Court agrees that the claims of the ‘021 patent only
expressly describe a device used to monitor various
hemodynamic parameters. If § 112 only requires the ‘021
patent description to enable one of ordinary skill in the art to
make and use this diagnostic device, then obviously
20. Dkt. # 260, p. 2 (citing Berardinucci Report, Exhibit A,
S 3)
in
65a
Appendix E
testimony about whether the claimed device could achieve
the therapeutic goals set forth in the description is irrelevant.
The first paragraph of 35 U.S.C. § 112 states:
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, or
with which it is most nearly connected, to make
and use the same, and shall set forth the best mode
contemplated by the inventor of carrying out his
invention.
The enablement requirement of § 112 demands that the
patent specification enable “those skilled in the art to make
and use the full scope of the claimed invention without
‘undue experimentation.’ ” Genentech, Inc. v. Novo Nordisk
A/S, 108 F.3d 1361, 1365 (Fed.Cir.1997) (quoting In re
Wright, 999 F.2d 1557, 1561 (Fed.Cir.1993)). The question
the Court must resolve is what portions of the ‘021 patent
compose the “claimed invention.” Neutrino’s enablement
arguments rely on the “claimed invention” consisting of only
the patent claims. Conversely, Sonosite’s expert testimony
on the issue of enablement indicates that Sonosite considers
the therapeutic method outlined in the Summary of the
Invention to be part of the “claimed invention.””!
21. Obviously, Section 112 expressly describes the “claimed
invention” in terms of the written description in the specification.
See Markman v. Westview Instruments, Inc., 52 F.3d 967, 979
(Fed.Cir.1995). The Court does not interpret Neutrino’s argument to
(Cont'd)
66a
Appendix E
Because “the scope of the claims must be less than or
equal to the scope of the enablement,” Nat'l Recovery Tech.,
Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196
(Fed.Cir.1999), it follows that the scope of the enablement
may be broader than the claims. However, the written
description need not enable anything broader than the scope
of the claims. The fact that the claims dictate the minimum
scope of enablement does not make all portions of the written
description that do not literally and exactly reflect the terms
of the claims irrelevant. To the contrary, enablement is
determined based on the written description, and the features
giving purpose to a claimed device in the written description
are relevant to enablement even if absent in the literal terms
of the claims. See Nat'l Recovery Techs., Inc. v. Magnetic
Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed.Cir. 1999).
For purposes of determining whether the enablement
requirement of § 112 has been satisfied, the Court considers
the claims interpreted in light of the specifications and
drawings and the Underlying purpose of the invention. The
claims demarcate an area of invention within the exclusive
possession of the patentee. The requirement that the patent
- (Cont'd)
mean that the specification should be ignored all together, but that
the parts of the specification that do not specifically interpret the
terms of the claims are without the scope of the “claimed invention.”
For example, under Neutrino’s interpretation, that portion of the
specification describing the components of the diagnostic device
would be within the scope of the “claimed invention,” whereas any
reference to a penis in the specification would not be within the
scope of the “claimed invention” because a penis is not mentioned
in the claims. Conversely, Sonosite seems to embrace a process of
interpretation that would include the entire written description in
the specification.
67a
Appendix E
description be enabling is the quid pro quo the patentee must
offer in exchange for exclusive possession. The written
description in the patent must allow others in the field to
realize this new technology and put it to use. Therefore, the
claimed invention cannot be interpreted in the absence of
the underlying purpose of the patent. See Decca, Ltd. v.
United States, 210 Ct.Cl. 546, 544 F.2d 1070, 1077
(Ct.Cl.1976) (“The machine patented may be imperfect in
its operation; but if it embodies the general principle and
works ... it is enough.”) (emphasis added),
The 27 claims of the ‘021 patent only describe
“an apparatus ... to monitor hemodynamic parameters.”
However, the written description instructs that the “invention
is directed toward a method and apparatus for stimulating
and/or monitoring hemodynamic activity, such as blood flow,
in a penis.” The claims must be interpreted in light of this
broader assertion. Because the described invention is for
“stimulating and/or monitoring” (emphasis added), the
claimed invention can monitor without the ability to
stimulate.” Because the claims do not discuss stimulation,
and because the specifications do not require the ability to
both monitor and stimulate, the Court finds that the “claimed
invention” is “directed toward a method and apparatus for
monitoring hemodynamic activity. . . .” However, because the
22. The Court considered at length the possibility that the “and/
or” designation might describe a device capable of both stimulating
and monitoring, but with the ability to only do one or the other at a
time. Although the descriptions support this interpretation, the
explicit reference only to a monitoring capability in the claims leads
the Court to conclude that only this use is part of the claimed
invention.
68a
Appendix E
general principle underlying the invention was expressly the
treatment of erectile dysfunction, the Court finds that the
“claimed invention,” for purposes of the enablement analysis,
is directed specifically and exclusively at the penis.
Therefore, the Court finds that, in order for the ‘021 patent
to satisfy the requirements of § 112, the patent description
must enable one of ordinary skill in the art-to make and use
an apparatus capable of measuring hemodynamic activity in
a penis.
The Court will analyze the relevance of
Dr. Berardinucci’s testimony in light of this interpretation
of the “claimed invention” under the enablement defense.
Neutrino contends that the analysis in Dr. Berardinucci’s
report is based entirely on the incorrect assumption that the
‘021 patent claims a therapeutic device. The Court agrees.
Dr. Berardinucci states in his report that “I have been asked
to review [the ‘021 patent], and form a professional, medical
opinion as to whether the device described and claimed in
that patent would cure erectile dysfunction by applying
ultrasound energy to the penis in order to stimulate blood
flow.’ Because that analysis is not relevant to Sonosite’s
enablement defense, Dr. Berardinucci’s opinions are
irrelevant.”*
23. Dkt. # 260, Exhibit A, p. 1.
24. The Court notes that, even if the claimed invention did
include the therapeutic method contained in the description,
‘Dr. Berardinucci’s testimony would be irrelevant because he states
that he does not express any opinion about whether or not ultrasound
energy transmitted into the penis would stimulate blood flow.
(Cont'd)
69a
Appendix E
IV. Cameron Weiffenbach
Neutrino objects to the testimony of Cameron
Weiffenbach on the issues of “new matter” and “inequitable
conduct” on the grounds that both are irrelevant and
unreliable. Specifically, Neutrino objects to the relevancy of
Mr. Weiffenbach’s critique of the Patent Office practices and
procedures and his testimony about Richard Redano’s status
as a registered patent attorney. Neutrino also argues that
Mr. Weiffenbach’s testimony about “new matter” and
“inequitable conduct” are not supported by any of the
Daubert reliability factors. Finally, Neutrino contends that
certain portions of Mr. Weiffenbach’s testimony are
impermissible instructions on the law to the jury.
Neutrino concedes that Mr. Weiffenbach’s general
testimony regarding the patenting process and Patent Office
(“PTO”) procedures are appropriate expert testimony that
he is qualified to offer. However, Neutrino objects to
testimony suggesting deficiencies in the PTO process that
might serve to undermine the presumption of validity
afforded final determinations of the PTO.” Sonosite argues -
that Mr. Weiffenbach’s testimony that the patent examiner
(Cont'd)
Dr. Berardinucci’s testimony is only that ultrasound energy could
not cause an erection. The ‘021 patent never suggests that ultrasound
energy could cause an erection. The therapeutic method in the
description suggests that ultrasound energy could stimulate blood
flow in the penis and thereby accelerate the delivery of drugs
designed to cure erectile dysfunction.
25. The presumption of validity is codified at 35 U.S.C. § 282.
70a
Appendix E
committed several errors during prosecution of the ‘021
patent is relevant to the issue of whether or not Richard
Redano deliberately took advantage of an error by the PTO
to include a “new matter” in the ‘021 patent. Sonosite
contends that Mr. Weiffenbach’s testimony establishes that
the PTO made errors and that Redano would have recognized
those errors and therefore the amendment made to the ‘021
patent was procured through inequitable conduct. Neutrino
argues, however, that evidence of problems in the PTO
prosecution is not admissible. To support this contention,
Neutrino cites to a case where a district court refused to allow
an expert “to speculate about possible defects, errors, or
omissions in the application process.” that would serve to
undermine the presumption of validity afforded final
determinations by the PTO. Bausch & Lomb, Inc. v. Alcon
Labs., Inc., 79 FSupp.2d 252, 255-56 (W.D.N.Y.2000).
The Court finds that, to the extent that Mr. Weiffenbach’s
testimony simply addresses-the potential pressures and
potential for error at the PTO, such testimony is inadmissible.
See American Hoist & Derrick Co. v. Sowa & Sons, Inc.,
725 F.2d 1350, 1360 (Fed.Cir. 1984). Such general testimony
tends to undermine the presumption of validity. However,
the fact that invalidity defenses are permitted indicates that
the presumption of validity is a rebuttable presumption.
Evidence of mistakes or misconduct during the patent
prosecution are relevant to determining the actual validity
(as opposed to the presumed validity) of the patent. “[T]he
examiner’s and the applicant’s absolute compliance with the
internal rules of the patent examination” is relevant where
there is evidence of inequitable conduct. Magnivision, Inc.
v. Bonneau Co., 115 F.3d 956, 960-61 (Fed.Cir.1997).
Tla
Appendix E
Therefore, the Court finds that testimony about specific PTO
errors in the prosecution of the ‘021 patent are admissible to
show inequitable conduct.
For similar reasons, the Court finds that testimony that
Richard Redano was a registered patent attorney at the time
of the patent prosecution is proper. Sonosite contends that
“registered patent attorneys are presumed to know the patent
law and PTO rules and procedures.” The Court agrees that
the jury could reasonably find that Richard Redano’s trained
knowledge of patent law suggests that he would have been
aware of certain PTO errors and consequently, that he took
advantage of those errors and expanded the scope of the ‘021
patent through fraud.
Neutrino also objects to Mr. Weiffenbach’s opinion that
Richard Redano’s legal conclusion that “no new matter has
been added” in the May 4th amendment and the November
14th amendment was a misrepresentation to the PTO on the
grounds that “Mr. Redano’s legal arguments to the Patent
Office cannot, as a matter of law, constitute inequitable
conduct.””’ Neutrino contends that “statements of fact or legal
arguments made by the prosecuting party” are immaterial to
the issue of a patent’s validity.% Sonosite argues that this is
not true in the context of an inequitable conduct defense.
The Court agrees. Neutrino’s characterization of the
26. Dkt. # 301, p. 28.
27. Dkt. #261, p. 20.
28. Id. at 21.
72a
Appendix E
presumption of validity suggests that the law presumes that
the patent examiner did not rely on misrepresentations made
by the applicant. To the contrary, if the misrepresentations
made were material, the law presumes that the entire
application was tainted by deceit. Molins PLC v. Textron,
Inc., 48 F.3d 1172, 1178 (Fed.Cir.1995); see also 37 C.F.R.
§ 1.56 (2003). Therefore, material representations made by
Richard Redano to the PTO during the prosecution are
relevant to the issue of inequitable conduct. That clarified,
the Court finds, however, that Mr. Weiffenbach’s opinions
about the misrepresentative nature of Mr. Redano’s
statements to the PTO are based on opinions he is unqualified
to offer. As set forth in the following paragraphs the Court
finds that Mr. Weiffenbach is unqualified to testify about
whether the amendments made to the ‘021 patent were in
fact “new matter.”
Neutrino contends that Mr. Weiffenbach is not qualified
to testify about whether or not material contained in the
May 4th and November 14th amendments was “new matter”
on the grounds that he is not “one of ordinary skill in the
art.” Neutrino claims that the relevant inquiry is whether one
of ordinary skill in the art would have understood that the
material contained in the amendments was “new matter.” The
Court has already resolved the art area as “the designing,
testing, and building” of medical ultrasound devices. Sonosite
does not argue that Mr. Weiffenbach is skilled in this area,
but instead contends that he is particularly qualified to
consider the patent application materials from the perspective
of a patent examiner and patent attorney and his testimony
serves to tie the technical opinions of Dr. Jens Quistgaard
and Ms. Joan Baker on the issue of “new matter” to the
73a
Appendix E
prosecution record of the ‘021 patent. For an amendment to
a patent application to comply with 35 U.S.C. § 132, a person
of ordinary skill in the art must be able to look ai che patent
application as of the filing date and determine that the claimed
invention included the later-claimed subject matter.
TurboCare Div. of Demag Delaval Turbomach. Corp. v. Gen.
Elec. Co., 264 F.3d 1111, 1118-19 (Fed.Cir.2001). The law
makes no exception for the expert testimony of patent
examiners, patent attorneys, or any other patent law experts.
If the witness is unqualified to testify from the perspective
of “one of ordinary skill in the art,” then his testimony is
inadmissible on the issue of “new matter.” Therefore, the
Court agrees with Neutrino that Mr. Weiffenbach is not
qualified to testify as to whether the amendments constituted
“new matter” as prohibited by the written description
requirement of § 112.
The Court’s finding that Mr. Weiffenbach is not qualified
to testify as to whether amendments made to the ‘021 patent
constituted “new matter” seriously limits the scope of his
testimony about errors made during the patent prosecution.
Mr. Weiffenbach can properly testify as to any actual defects
that occurred in the application process, but he is not qualified
to identify any amendment made to the ‘021 patent as “new
matter” and, therefore, cannot properly conclude that the
patent examiner committed an error by failing to identify
such as “new matter.” Mr. Weiffenbach’s testimony should
be strictly limited to a general examination of the patent
application process and any specific irregularities in
prosecution of the ‘021 patent that he is qualified to identify.
See Bausch & Lomb, Inc. v. Alcon Laboratories, Inc., 79
F.Supp.2d 252, 255-56 (W.D.N.Y.2000) (only allowing
74a
Appendix E
expert witness who was a former patent examiner to testify
about general patent application process and any “evidence
that there actually were defects in the particular application
process at issue.”); see also Applied Materials, Inc. v.
Advanced Semiconductors Materials America, Inc., 1995
WL 261407, *3 (N.D.Cal. Apr.25, 1995). Similarly,
Mr. Weiffenbach’s testimony about misrepresentations made
by Richard Redano should be limited to defects in the
particular application process that a patent attorney would
have recognized, and should not convey any opinion about
whether or not Redano would have recognized the
amendments made to the ‘021 patent as “new matter.”
However, other opinions about Redano’s knowledge, such
as knowledge that “he was supposed to particularly point
Out support in the original filed ‘021 Patent application for
his statement that ‘no new matter has been added’ ”” are
appropriate.
Neutrino also objects to certain portions of
Mr. Weiffenbach’s testimony as improper instructions on the
law to the jury. Specifically, Neutrino contends that
Mr. Weiffenbach’s opinion that Redano did not conceive of
the claimed device and Mr. Weiffenbach’s opinion regarding
the explicit or inherent disclosures of the “901 patent are
impermissible instructions to the finder of fact. Certainly,
Neutrino is correct to point out that witness testimony
regarding what the law requires is unnecessary and improper.
See Owen v. Kerr-McGee Corp., 698 F.2d 236, 239-40 (Sth
Cir.1983). Sonosite argues that Mr. Weiffenbach’s testimony
is not designed to instruct the jury on the law because it is
29. Dkt. # 310, p. 37.
75a
Appendix E
“couched in terms of the evidence that the expert
considered.” However, the Court finds that portions of
Sections B and C on pages 60 and 61 of Mr. Weiffenbach’s
report attempt to explain the legal standards as opposed to
offering appropriate conclusions in terms of legal standards.
Therefore, that portion of Mr. Weiffcnbach’s testimony
regarding the concept of priority that explains how a claim
is entitled to a particular filing date is an unnecessary
explanation of the law that should be excluded. Furthermore,
Mr. Weiffenbach is not qualified to testify about the claimed
device under the ‘901 patent. As discussed above,
Mr. Weiffenbach is not one of ordinary skill in the art and
therefore his testimony about facts necessary to establish the
understanding of one of ordinary skill in the art is not helpful
to the trier of fact.
Similarly, that portion of Mr. Weiffenbach’s testimony
regarding inventorship that explains the legal standard for
inventorship and conception is not an appropriate subject
for expert testimony. Furthermore, the Court finds that the
subsequent testimony regarding the disclosures made in the
‘021 patent are inadmissible as Mr. Weiffenbach is
unqualified to opine about what one of ordinary skill in the
art would understand from the written description and claims
of the ‘021 patent. Contrary to Sonosite’s assertion,
“specialized knowledge and experience in the patent field”
does not automatically qualify Mr. Weiffenbach to testify
about every aspect of the ‘021 patent.
30. Dkt. #301, p. 43 (citing Fiataruoio v. United States, 8 F.3d
930, 942 (2d Cir. 1993)).
76a
Appendix E
Finally, Neutrino objects to Mr. Weiffenbach’s testimony
regarding the disclosure of the Pohl Patent (U.S. Patent No.
5,578,060) on the grounds that he is not qualified to testify
as one of ordinary skill in the art. Contrary to Sonosite’s
argument that “Mr. Weiffenbach’s 30 years of experience as
a patent practitioner and former patent examiner qualify him
to offer this testimony,” the law demands that testimony on
the disclosures of a patent be offered from the perspective of
one of ordinary skill in the art. See Adang v. Fischhoff, 286
F.3d 1346, 1355 (Fed.Cir.2002); In re Wands, 858 F.2d 731,
737 (Fed.Cir. 1988). Mr. Weiffenbach’s experience in the field
of patent lawyering is simply irrelevant and his testimony
about the Pohl Patent is inadmissible.
V. Jens U. Quistgaard
Neutrino seeks to exclude the testimony of Jens
Quistgaard (“Dr.Quistgaard”) in two motions. The first
motion claims that there is no reliable basis for
Dr. Quistgaard’s opinions on “new matter,” “enablement,”
and “anticipation,” and further that opinions regarding
eXaminer error are impermissible. The second motion
contends that Dr. Quistgaard’s “lack of infringement”
opinions are unreliable and should be excluded.
First, Neutrino asserts that Dr. Quistgaard’s “new matter”
testimony is unreliable because it is not offered from the
perspective of one of ordinary skill in the art. Neutrino
contends that Dr. Quistgaard “has not established that he
possesses any specific knowledge of who ‘one of ordinary
skill in the art’ is, or what this individual would have
concluded from reading the patent application at the time of
77a
Appendix E
its filing.”*' Sonosite argues that Dr. Quistgaard did qualify
the conclusions of his report in terms of “one of ordinary
skill in the art” and that Neutrino failed to question him about
what he believes the level of ordinary skill in the art to be
and whether he applied that standard to his opinions. The
Court believes that the following introductory passage from
Dr. Quistgaard’s report resolves the issue of the application
of the “one of ordinary skill in the art” standard:
As a result of my education and experience, I am very
familiar with medical ultrasound technology, and designing,
testing and building medical ultrasound devices, including
analyzing their structure and how they function and perform.
I believe that I am an expert in this field and can provide
opinions on how one with ordinary skill in this art would
understand the structure, function and performance of devices
described in patent disclosures such as ones in U.S. patents
5,947,901 and 6,221,021.”
The Court is satisfied that Dr. Quistgaard’s qualifications
Support this opinion. Any exception Neutrino takes to
Dr. Quistgaard’s formulation or application of the level of
ordinary skill in the art is a factual dispute ripe for cross-
examination.
Neutrino also objects to Dr. Quistgaard’s “enablement”
opinions on the grounds that he failed to conduct analysis
from the perspective of one of ordinary skill in the art and
31. Dkt. # 262, p. 3.
32. Dkt. # 262, Exhibit A, Quistgaard Report, p. 24.
78a
Appendix E
he failed to focus on the invention claimed in the ‘021 patent.
As discussed above, the Court is satisfied that Dr. Quistgaard
has conducted his analysis from a legally acceptable
formulation of the level of ordinary skill in the art. If Neutrino
disagrees with the facts underlying Dr. Quistgaard’s
formulation and application of that standard, it is free to
explore the basis for its disagreement on cross-examination.
Neutrino’s contention that Dr. Quistgaard failed to focus on
the “claimed invention” when analyzing the ‘021 patent under
§ 112 is based on the same excessively narrow interpretation
of the “claimed invention” discussed above in relation to
the testimony of Dr. Berardinucci. Neutrino objects to
Dr. Quistgaard’s reliance on the proportions of the device
depicted in the drawings on the grounds that the Court’s claim
construction simply described the ultrasonography generator
as “[a] body that 1s sized such that it can be held by hand
and, so held, moved from one location to another.” However,
as the Court discussed above, construction of the claims to
determine the scope of possession for purposes of identifying
infringement is different than analysis of the claimed
invention for purposes of determining enablement under
§ 112. The enablement analysis asks whether the written
description, including the drawings, allows enablement at
least as broad as the scope of the claims. If Neutrinc contends
that the written description in the ‘021 patent would enable
one of ordinary skill in the art to make and use a device with
capabilities at least as broad as the claims, it is appropriate
for Sonosite’s enablement expert to look to the written
description, including the drawings to see if they so instruct.
Neutrino’s objection to this testimony is misplaced.
79a
Appendix E
Neutrino also objects to Dr. Quistgaard’s opinions
regarding patent examiner error on the ground that such
testimony is an inappropriate attempt to rebut the
presumption of validity afforded a duly granted patent.
Sonosite argues in response that Dr. Quistgaard’s opinion is
not generalized testimony about problcms in the PTO, but
identifies specific defects in the prosecution of the ‘021 patent
that undermine its validity. As discussed above, the
presumption of validity is a rebuttable presumption and
therefore does not preclude all evidence of patent prosecution
defects. The prohibition against generalized testimony about
problems in the PTO articulated in cases such as Bausch &
Lomb, Inc. v. Alcon Labs., Inc., 79 F.Supp.2d 252, 255-56
(W.D.N.Y.2000), and Applied Materials, Inc. v. Adv.
Semiconductor Materials America, Inc., 1995 WL 261407,
*3 (N.D.Cal.1995), is designed to prevent the burden of proof
from being shifted to the party defending a patent’s validity
upon a showing of irregularities in the patent prosecution.
Even evidence of specific prosecution defects, such as that
offered in Dr. Quistgaard’s testimony, cannot shift the burden
of proof from the defendant. However, this does not make
specific evidence of prosecution defects irrelevant. As the
Court explained above, evidence of specific prosecution
defects can be relevant to the issue of inequitable conduct.
Dr. Quistgaard offers his opinion that two erroneous
statements were made by the patent examiner in connection
with his investigation into “new matter.” Dr. Quistgaard’s
testimony is essentially that Richard Redano made incorrect
statements about the hand-held nature of the ultrasonography
generator to the patent examiner and that the patent examiner
erroneously found support for the hand-held amendment in
a patent incorporated by reference in the original patent
80a
Appendix E
application.” Testimony about the patent examiner’s
allegedly erroneous interpretation of United States Patent No.
5,983,783 is relevant to the issue of “new matter” and,
therefore, admissible.
Finally, Neutrino contends that there is no reliable basis
for Dr. Quistgaard’s opinion that the Diasonics ultrasound
device anticipates the claims of the ‘021 patent on the grounds
that Dr. Quistgaard offers no facts to support this conclusion
in his report. Typically, testimony concerning anticipation
must identify each claim element, state the witnesses’
interpretation of the claim element and explain in detail how
each claim element is disclosed in the prior art reference.
Schumer v. Laboratory Computer Sys., Inc., 308 F.3d 1304,
1315-16 (Fed.Cir.2002). Testimony is insufficient if it is
merely conclusory. /d. Dr. Quistgaard states in his deposition
testimony that he based his conclusion on a comparison of
the claims of the two devices, but fails to explain how each
claim of the ‘021 patent is disclosed in the claims of the
Diasonics patent. As such, Dr. Quistgaard’s testimony on the
issue of anticipation of the Diasonics device is not sufficiently
reliable under Daubert and is therefore inadmissible.
In its second motion pertaining to the testimony of
Dr. Quistgaard, Neutrino contends that his opinions on “lack
of infringement” are unreliable on the grounds that (1) the
Court has already determined that Sonosite’s “old products”
literally infringe the ‘021 patent, (2) Dr. Quistgaard’s reverse
doctrine of equivalents analysis is flawed as a matter of law,
(3) Dr. Quistgaard failed to apply the Court’s Markman claim
33. Dkt. # 262, Exhibit A, pp. 3-4.
8la
Appendix E
construction, and (4) Quistgaard incorrectly applies an
invalidity defense to his infringement analysis.
Neutrino contends that Dr. Quistgaard’s opinion that
“none of Sonosite’s medical ultrasound products infringe any
of the claims”* of the ‘021 patent is inappropriate because
the Court already found that certain Sonosite products
literally infringe the ‘021 patent.** Sonosite argues in
response that the Court’s rulings did not apply to 5 of the 9
Sonosite products that Neutrino alleges infringe the ‘021
patent. Both Parties are correct. Dr. Quistgaard’s testimony
that the Sonosite 180, the Sonosite 180 PLUS, the SonoHeart,
and the SonoHeart PLUS do not literally infringe the ‘021
patent or are so far chunged from the claimed invention in
the ‘021 patent as to not infringe under the reverse doctrine
of equivalents is irrelevant because the Court has already
held otherwise. That is, the Court has already determined
that these products do literally infringe the ‘021 patent and
the reverse doctrine of equivalents does not apply. However,
the Court’s previous Order does not address the SonoHeart
Elite, the iLook 15, the iLook 25, the TITAN, and the
MicroMaxx. As the Court has not resolved the issue of
infringement with regard to these five newer devices,
Dr. Quistgaard’s testimony on the matter is still relevant.
However, to the extent that any of Dr. Quistgaard’s testimony
relies on an interpretation of the ‘021 patent claims and
written description that does not include an ultrasonography
generator contained within a body sized to be hand-held, such
34. Dkt. # 266, p. 2.
35. Dkt. # 162.
82a
Appendix E
testimony is irrelevant. The Court has-held, and has
reemphasized several times, that the claims of the patent
include an ultrasonography generator within a “body that is
sized such that it can be held by hand... .” The Court has
found that the claims of the patent include such a description
of the ultrasonography generator for purposes of determining
literal infringement and that the written description includes
the ultrasonography generator within a hand-held body for
purposes of determining enablement under § 112 and for
evaluating infringement under the reverse doctrine of
equivalents.”
Sonosite contends that the written description and the
claims were improperly amended to include the “sized to be
hand-held” language and that, therefore, the patent should
not be read to include a hand-held ultrasonography generator
for purposes of determining infringement and applying the
reverse doctrine of equivalents. Sonosite’s argument confuses
the distinct analyses applied to a determination of
infringement and a determination of invalidity. If Richard
Redano amended the ‘021 patent to include matter that was
not supported in the original patent application, then that
“new matter” invalidates the entire patent. If the patent is
36. U.S. Pat. No. 6,221,021, preferred embodiment:
... the display is located or mounted in a portable unit,
such as the ultrasonography generator. As shown in Fig.
2, the ultrasonography gencrator unit is sized to be
grasped or held in a user’s hand. In the preferred
embodiment shown in Fig. 3, the system is physically
housed or located within the ultrasonography generator
unil.
83a
Appendix E
invalid, obviously Sonosite’s devices cannot infringe it.
However, the Court’s infringement analysis is applied
presuming the validity of the patent. The Court did not
evaluate whether the amendments made to the ‘021 patent
in May and November of 2000 were “new matter” when
determining that the Sonosite devices then at bar literally
infringed the ‘021 patent. Nor did the Court evaluate the
amendments for “new matter” when deciding that Sonosite
had failed to produce evidence that the reverse doctrine of
equivalents should apply. Dr. Quistgaard is certainly qualified
to testify about “new matter,” as the Court found above, but,
to the extent that Dr. Quistgaard’s opinions about
infringement assume that “new matter” was improperly added
to the ‘021 patent, those opinions are irrelevant. If the Court
or the jury finds that “new matter” was improperly added to
the ‘021 patent, then the Court’s finding of literal
infringement is irrelevant because the ‘021 patent is invalid.
But, the finding of infringement and the application of the
reverse doctrine of equivalents is based strictly on the
formulation of the ‘021 patent the PTO accepted and is
presented to this Court as U.S. Pat. No. 6,221,021. With that
limitation articulated, the Court declines to determine at this
time whether or not the finding of literal infringement as to
the Sonosite 180, the Sonosite 180 PLUS, the SonoHeart,
and the SonoHeart PLUS applies to the SonoHeart Elite, the
iLook 15, the iLook 25, the TITAN, and the MicroMaxx.
VI. Lauren S. Pflugrath
Neutrino challenges the reliability of Lauren S.
Pflugrath’s “anticipation” and “obviousness” opinions on the
grounds that he failed to consider and properly apply the
84a
Appendix E
perspective of “one of ordinary skill in the art.” Neutrino
also objects to Mr. Pflugrgth’s “obviousness” opinions on
the grounds that he failed to consider any of the Graham
factors in his analysis.
Neutrino contends that Mr. Pflugrath failed to make any
investigation into the appropriate level of ordinary skill in
the art and that, consequently, his opinions on “anticipation”
and “obviousness” are unreliable. Neutrino contends that the
absence of factual analysis underlying Mr. Pflugrath’s
conclusions applying the
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