The opinion of the court was delivered by: Jones, Judge
Defendant Becton Dickinson has moved for summary judgment on four
issues arguing: (1) that the `535 patent, `323 patent, and the `906
patent are invalid as anticipated under 35 U.S.C. § 102(b) in view of
a June 1991 issue of Novo Nordisk's informational brochure, Medview,
containing an article by Lene Lytzen; (2) that all claims of the `323
patent and claims 11-14 of the `906 patent are invalid as anticipated
under 35 U.S.C. § 102(b) in view of a May 1993 advertising brochure
for Novo's NovoFine G30 pen needle product; (3) that Becton's G31.
insulin pen syringe needle products do not infringe the `906 patent; and
(4) that if Becton is found to have infringed on Novo's 906 patent, no
damages have accrued due to Novo's failure to put Becton on notice of the
A patent is presumed to be valid, see 35 U.S.C. § 282, and this
presumption only can be overcome by clear and convincing evidence to the
contrary. See, e.g., WMS Gaming Inc. v. International Game Tech.,
184 F.3d 1339, 1355 (Fed. Cir. 1999). To be entitled to summary
judgment, therefore, Becton has to establish that there are no material
facts in dispute.
A. Lytzen Article as Prior Art
Becton urges this Court to rule that Novo made a binding admission that
the Lytzen article was a printed publication when it requested
reexamination of the `535 patent. The Court rejects this conclusion as
unfair to Novo and in any event, as without support.
It is recognized that positions are often taken during patent
prosecutions out of convenience and expedience, and therefore such
positions should not be given conclusive effect. See, e.g., Quad Envtl.
Tech. v. Union Sanitary Dist., 946 F.2d 870, 873 (Fed. Cir. 1991)
(refusing to treat the filing of a terminal disclaimer over a double
patenting as an admission that the double patenting reference was
Becton concedes that Novo submitted Lytzen to the Patent Office during
the reexamination with the express proviso that "[t]he Patent Owner
admits, for purposes of this reexamination proceeding only, that Lytzen
is prior art under 35 U.S.C. § 102(b)." (emphasis added) The Patent
Office conducted the reexamination on Nova's conditional representation
that it was a publication for purposes of the reexamination proceeding
and concluded that Lytzen was "not material to the patentability of the
[`535 patent]" and created "no substantial new question of
Under the circumstances, Becton's various arguments regarding the
reexamination proceeding are meritless. First, under the Manual of Patent
Examining Procedure ("MPEP"), if the Patent Office had found Nova's
conditional admission concerning the Lytzen article to be improper, it
would have been obligated to inform Nova and return the citation papers
and refuse to conduct the reexamination.
Second, since the Patent Office did not find the procedure improper,
Becton's contention that conducting a reexamination proceeding based an a
conditional admission constitutes an impermissible "advisory" opinion by
the Patent Office and/or an impermissible expenditure of government funds
is without merit.
Third, Becton's argument that citation of the Lytzen article during the
prosecution of the `323 and `906 patents constitutes an admission that
Lytzen is a prior art publication is incorrect. In Standard Manufacturing
Company v. United States, 25 Cl. Ct. 1, 61 (1991), the United States
Claims Court rejected such an argument holding:
The Patent & Trademark Office clearly recognize[s] that
an applicant may choose to furnish material information
in an Information Disclosure Statement which does not
necessarily depict prior art. The Court, therefore,
finds that Standard's disclosure of the document in
question in the required disclosure statement should
not be considered an acknowledgment, declaration,
concession or any kind of recognition of the fact that
the disclosed publication is prior art.
Id. at 61-62. Moreover, 37 C.F.R. § 1.97 (h) provides that "[t]he
filing of an information disclosure statement shall not be construed to
be an admission that the information cited in the statement is, or is
considered to be, material to patentability. . . ."
Fourth, Becton argues that Nova should have attempted to "correct" the
cover pages of the patents-in-suit to remove the reference to the Lytzen
article. However, the Patent Examiner is required to list on the face of
the patent or reexamination certificate all references considered during
prosecution, regardless of whether those references are technically prior
art. See MPEP § 130.12. Further, citation of a reference in an
information disclosure statement — which requires the Patent Office
to list the reference on the front cover of the patent — does not
constitute an admission that the reference is prior art. Thus, the Lytzen
article is properly cited on the cover pages of the patents-in-suits.
Accordingly, the Court declines to rule that the Lytzen article is
prior art based upon Novo's conditional admission.
B. Lytzen and the Elements of the Patents-in-Suit
To anticipate a claim, a reference must: (1) disclose every element of
the challenged claim; and (2) enable one
skilled in the art to make the
claimed subject matter. See PPG Indus., Inc. v. Guardian Indus. Corp.,
75 F.3d 1558, 1566 (Fed. Cir. 1996). It is not sufficient that each
element be found somewhere in the reference, the elements must be
"arranged as in the claim." Lindemannn Maschinenfabrik GmbH v. American
Hoist & Derrick Co., 730 F.2d 1452, 1458 (Fed. Cir. 1984). Further, the
reference must be sufficiently clear so as to prove the existence of each
and every element in the reference. See Motorola, Inc. v. Interdigital
Tech. Corp., 121 F.3d 1461, 1473 (Fed. Cir. 1997).
The elements of claim of the `535 patent are as follows:
(1) An insulin injection system compromising;
(2) a pen shape syringe system comprising;
(3) a cartridge with insulin; and
(5) wherein the injection needle is a G30 needle; and
(6) the cartridge contains an insulin type which may
freely flow through the G30 needle.
Becton's argument for the proposition that the Lytzen article discloses
the elements of claim 1 of the `535 patent is based on the deposition
testimony of one of its experts:
It [Lytzen] describes the 30-gage needle, describes
the needle, I guess the needle hub itself that's shown
on the — actually shown on the cover, even
though it only — it's only for a 27-gauge
needle, but the concept is there and then the 30-gauge
needle is described in the text portion.
Sharrott Decl. Exh. 37, Synderman Tr. 44:14-20. With respect to the
insulin disclosed in Lytzen, Becton's expert also stated: "As far as the
insulin that would flow freely through a 30-gauge needle, the only
insulin that was available in cartridges is insulin that would flow
through a 30-gauge needle." Id. at 45:9-13.
To rebut this, Novo's expert, see Fischell Declaration, opines that
"[n]owhere in the Lytzen article does it disclose or teach that one
should use a G30 needle with a pen syringe with a cartridge." 1999
Fischell Decl. ¶ 6. Moreover, "[n]o specific insulin is described in
the Lytzen article that can be used with a pen shaped syringe and a
cartridge and a G30 needle." Id. Finally, as Dr. Fischell stated, one
cannot conclude, at this juncture, that "a person of skill in the art of
medical devices could . . . utilize the Lytzen article to construct the
system described in the `535 and `323 patents." Id. at ¶ 23.
In light of these contrary opinions, there are, at a minimum, genuine
issues of material fact as to whether: (1) Lytzen teaches each and every
element of claim 1 of the `535 patent; (2) Lytzen discloses the elements
of claim 1 as arranged and disclosed in the `535 patent; and (3) Lytzen
b. Dependent Claims 2-10 of the `535 Patent
Each of the dependent claims of the `535 patent contain all the
elements of the independent claim 1 and the particular additional
elements recited in each particular dependent claim. See
35 U.S.C. § 114, ¶ 4. Because there are genuine issues of
material fact as to whether Lytzen discloses each element of claim 1 of
the `535 patent, genuine issues of material fact exist as to each of
claim 1's dependent claims. See Corning Glass Works v. Sumitomo Elec.
USA. Inc., 868 F.2d 1251, 1256 n.4 (Fed. Cir. 1986). Moreover, ...