Court Opinion

ID: 856109
Source: CourtListenerOpinion
Date Created: 2013-03-25 15:26:15.877251+00
Date Added: 2024-06-11T09:10:02.577410
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
              __________________________

               CHANDLER DAWSON,
                   Appellant,

                          v.
       CHANDLER DAWSON AND LYLE BOWMAN,
                 Cross-Appellant.
              __________________________

             2012-1214,-1215,-1216,-1217
             __________________________

 Appeals from the United States Patent and Trademark
  Office, Board of Patent Appeals and Interferences in
          Interference Nos. 105,719 & 105,729
   .
             ___________________________

               Decided: March 25, 2013
             ___________________________

 STEVEN B. KELBER, Berenato & White, LLC, of Bethes-
da, Maryland, argued for appellant.

 JOEL M. FREED, McDermott Will & Emery, LLP, of
Washington, DC, argued for cross-appellant. With him on
the brief were NATALIA BLINKOVA and AAMER AHMED.
               __________________________
DAWSON   v. DAWSON AND BOWMAN                             2
 Before REYNA, BRYSON *, and WALLACH, Circuit Judges.

   Opinion for the court filed by Circuit Judge BRYSON.
    Dissenting opinion filed by Circuit Judge REYNA.

BRYSON, Circuit Judge.

    This is a patent interference case concerning a meth-
od for topically treating and preventing infections of the
eye. The patents and patent applications at issue de-
scribe well-known challenges in treating eyes and with
topical eye treatments in particular. For example, antibi-
otics that are applied topically must be able to reach and
penetrate the targeted tissue, and many antibiotics are
not suitable for such a task. In addition, medications
must be designed to minimize irritation and avoid toxic
responses in the eye. The inventions at issue in this case
claim to overcome such difficulties through a process for
topically applying an azalide antibiotic to the eye; the
question in the underlying interference proceedings was
who conceived of the inventions, and when.

                            I

    The relevant events begin in the summer of 1997, at
the inaugural meeting of the World Health Organization
(“WHO”) Alliance for the Elimination of Trachoma.
Trachoma is a bacterial infection of the eye that can lead
to blindness. Chandler Dawson and Thomas Leitman,
who at the time were both employed by the University of
California, San Francisco (“UCSF”), attended the WHO
meeting on behalf of the Francis I. Proctor Foundation, an
ocular disease research institution affiliated with UCSF.
At the meeting, Dr. Dawson gave a presentation related

         *  Judge Bryson assumed senior status on Janu-
ary 7, 2013.
3                           DAWSON   v. DAWSON AND BOWMAN
to the topical use of an antibiotic called azithromycin to
control trachoma.

    The WHO released a report of the meeting, entitled
Report of the First Meeting of the WHO Alliance for the
Global Elimination of Trachoma (“WHO Report”), that
contains a discussion of Dr. Dawson’s presentation. The
report stated that although oral azithromycin had been
used successfully against trachoma, “a topical azithromy-
cin preparation to treat the eye directly [wa]s not availa-
ble” at that time. The report listed several benefits of a
topical trachoma treatment and also a number of objec-
tions to such a treatment, including that “[n]o product is
available” and that the “[e]fficacy and dosing schedule”
would need to be determined. Similarly, the report
acknowledged that even after a product was developed, it
would need to be tested for “pharmacological characteris-
tics . . . and toxicity in the eye.” The report pointed out
that “several vehicles” were available to administer drugs
topically, and it listed a few of them, including a product
called Durasite. It did not, however, rank those options,
and it expressed uncertainty about how the “persistence
of [azithromycin] may occur in the external eye with
adequate topical delivery.” The report’s conclusion re-
ferred to Dr. Dawson’s “preliminary report on the possibil-
ity of developing a topical application of azithromycin”
and recommended that Dr. Dawson “continue to work
with The Edna McConnell Clark Foundation and Pfizer
Inc. to develop a topical application and report back at the
next meeting.”

    A second document from the WHO conference is enti-
tled Potential Use of Topical Azithromycin in Trachoma
Control Programmes (“WHO document”) and is attributed
to Dr. Dawson. UCSF contends that the WHO document
was Dr. Dawson’s outline for his presentation. The docu-
ment largely tracks the WHO Report and contains many
of the same statements about the current unavailability
DAWSON   v. DAWSON AND BOWMAN                               4
of a topical azithromycin formulation and objections to its
use. The most relevant difference between the two docu-
ments is the addition of the following three sentences in
the second document’s discussion of delivery vehicles:
“Because azithromycin has a low solubility in aqueous
solutions, one obvious preparation would be an ointment
like the 0.5% erythromycin ointment. The problems with
ointments for trachoma treatment are well known . . . .
Ointments are difficult to apply and poorly tolerated . . . .”

     Shortly after the WHO meeting, Dr. Dawson sought
help from others in developing his idea. He asked Ken-
neth Chern, a clinical fellow at the Proctor Foundation, to
contact Lyle Bowman, an employee at InSite Vision
Incorporated, a company engaged in research and devel-
opment of ophthalmic products. Because Dr. Dawson did
not have experience in preparing ophthalmic medication
formulations, he suggested that Dr. Chern enlist Dr.
Bowman’s assistance in creating a suitable ophthalmic
medication with azithromycin that could be applied
topically to the eye. Dr. Chern spoke with Dr. Bowman
and followed up with a letter dated July 10, 1997. The
letter conveyed Dr. Chern’s “interest[] in making a topical
preparation and testing the compound” and asked Dr.
Bowman to report back if he was successful in formulat-
ing a topical preparation. Along with 100 milligrams of
azithromycin, Dr. Chern enclosed “several articles which
describe different concentrations of azithromycin as used
in experimental studies as well as information about the
minimum inhibitory concentrations that are necessary for
killing bacteria.”

    A few weeks later, on July 31, 1997, Dr. Chern con-
tacted a pharmacist associated with the Proctor Founda-
tion named Charles Leiter. According to Dr. Chern, he
did so because he had not yet heard back from Dr. Bow-
man in response to his July 10 letter; there is no indica-
tion that Dr. Chern contacted Dr. Leiter at Dr. Dawson’s
5                            DAWSON   v. DAWSON AND BOWMAN
request. Dr. Chern sent Dr. Leiter some azithromycin
and asked to be notified “if [Dr. Leiter was] success[f]ul in
making an ointment or suspension from the powder.” Dr.
Chern noted that they were “looking to compare [Dr.
Leiter’s preparation] with erythromycin 0.5% ointment.”
The same day, Dr. Chern wrote to Pfizer to request more
azithromycin, explaining that they were “investigating
the possible formulation and use of azithromycin as a
drop or suspension” and needed more to “continue [their]
studies.”

    In response to Dr. Chern’s request, Dr. Leiter pre-
pared an ointment that used a mineral oil and petrolatum
carrier to release the antibiotic. The label is dated Au-
gust 4, 1997, and indicates that the ointment contained
0.5% azithromycin by weight. Dr. Leiter gave three tubes
of his formulation to Drs. Chern and Leitman, and Dr.
Chern applied some to his own eye. Dr. Chern stated that
he “did so not to treat an infection, but to establish for
[himself] that the medication was safe, and well-
tolerated—that it would not cause significant discomfort
or distress as applied.” Dr. Chern then told Drs. Dawson
and Leitman about his experience.

     From that point forward, UCSF contends that Dr.
Dawson was no longer involved in UCSF’s efforts to
develop a topical azithromycin treatment. In February
1998, however, the Proctor Foundation submitted a grant
request for additional funds related to trachoma research.
A section of that request entitled “Associated Studies on
Trachoma” is said to have been written by Dr. Dawson.
That section conveyed many of the same concerns with,
and objections to, topical azithromycin use that were
reflected in the WHO Report and the WHO document,
often word-for-word. In addition, the request reported
that Dr. Dawson was “now working with InSite” and that
“[c]hemists at InSite . . . feel that azithromycin is an ideal
compound to use with their ‘Durasite’ vehicle.” But it also
DAWSON   v. DAWSON AND BOWMAN                            6
stated that no final product had been developed and
asserted, for example, that “the primary problem is to
determine if azithromycin is absorbed to the tissue after
topical application to the eye” and that “[t]he immediate
hurdle to the development of a topical form of azithromy-
cin is testing the drug levels in the conjunctiva.”

     On March 31, 1999, Drs. Dawson and Bowman sub-
mitted a patent application for their invention. They
signed a declaration of joint inventorship and assigned
their rights to InSite. The application eventually led to
the issuance of the two patents at issue in this case—U.S.
Patent No. 6,239,113 (“the ’113 patent”), which issued on
May 29, 2001, and U.S. Patent No. 6,569,443 (“the ’443
patent”), which issued on May 27, 2003. Both patents are
entitled “Topical Treatment or Prevention of Ocular
Infections,” and the specifications point out many of the
difficulties with topical eye treatments that had been
noted earlier by Dr. Dawson and others during the devel-
opment process.

                            II

    On May 8, 2007, in order to provoke an interference,
UCSF filed a patent application that named Dr. Dawson
as the sole inventor and generally copied the specification
and claims from the ’113 and ’443 patents. Dr. Dawson,
however, declined to join UCSF’s submission. The Patent
and Trademark Office’s Board of Patent Appeals and
Interferences declared two interferences between UCSF’s
application and the two InSite patents. Interference
105,719 contains the following count (“the ’719 count”),
which tracks claim 3 of the ’113 patent:

   A process for treating an eye, which comprises:
7                           DAWSON   v. DAWSON AND BOWMAN
    topically applying an aqueous polymeric suspen-
    sion of an azalide antibiotic, wherein said suspen-
    sion comprises water,

    0.01% to 1.0% of an azalide antibiotic, and

    0.1 to 10% of a polymeric suspending agent which
    is a water-swellable water-insoluble cross-linked
    carboxy-vinyl polymer which comprises at least
    90% acrylic acid monomers and 0.1% to 5% cross-
    linking agent.

Interference 105,729 contains the following count (“the
’729 count”), which tracks claim 1 of the ’443 patent:

    A process for treating an eye, comprising:

    topically applying an azalide antibiotic to an eye
    in an amount effective to treat infection in a tis-
    sue of the eye, wherein said topically applying
    comprises supplying a depot of a composition con-
    taining said azalide antibiotic on the eye.

Both interferences named UCSF as the junior party and
InSite as the senior party. That meant that UCSF bore
the burden of proving, by a preponderance of the evidence,
that Dr. Dawson alone had conceived of the inventions
recited in the counts prior to March 1999.

    Lengthy proceedings ensued before the Board. The
parties filed numerous motions, exhibits, transcripts of
sworn testimony, and declarations. In November 2011,
the Board heard oral argument and issued its decision on
the merits. The Board began its opinion by construing
the interference counts. In so doing, it looked to the
patent specifications to define the term “treating” and the
related term “treat.” The specifications state, in relevant
part: “The amount of azalide antibiotic topically supplied
DAWSON   v. DAWSON AND BOWMAN                              8
is effective to treat or prevent infection in a tissue of the
eye. This means that the conditions of application result
in a retarding or suppression of the infection.” Based on
those statements, the Board construed the ’719 count to
cover “[a] process for retarding or suppressing infection in
a tissue of an eye,” and it construed the pertinent phrase
in the ’729 count to cover “topically applying an azalide
antibiotic to an eye in an amount effective to retard or
suppress infection in a tissue of the eye.”

    As to the issue of conception, the Board found that
UCSF had failed to prove sole conception by Dr. Dawson.
The Board found that Dr. Dawson “did not fully appreci-
ate how [his] idea was to be implemented in actual prac-
tice”; rather, the Board held, “[w]hat emerges from the
facts of this case is that inventor Dawson had a general
idea for a future research plan to come up with a composi-
tion for topical azithromycin to be applied to the eye to
treat infection.” The Board rejected UCSF’s contention
that Dr. Dawson’s contemporaneous disclosures of the
invention, such as the WHO Report, would have enabled
one of skill in the art to practice the invention because,
the Board concluded, “[t]he facts . . . show ‘more’ was
needed.” The Board determined that it was only after Dr.
Bowman became involved that “‘something’ significant
happened,” leading to the joint patent application in
March 1999.

    The Board also addressed conception in the specific
context of the two interference counts. As to the ’719
count, the Board found “no evidence to suggest a complete
conception of the specific formulation.” The Board ruled
that it was not enough for UCSF to claim that Durasite is
the “polymeric suspending agent” described in the count
because the WHO documents “consider Durasite® but fail
to establish a concentration of azithromycin” and because
the ointment made for Dr. Chern did not use Durasite.
Similarly, the Board held that the ’729 count “explicitly
9                           DAWSON   v. DAWSON AND BOWMAN
calls for use of an amount effective to treat infection in a
tissue of the eye” and that UCSF did not “establish[] that
inventor Dawson appreciated a precise formulation to put
his ‘idea’ into practice.” The Board reiterated that Dr.
Dawson needed Dr. Bowman’s collaboration to reach that
point.

    The Board noted “several problems with [UCSF’s]
case” and expressed considerable concern with UCSF’s
evidence as presented. The Board remarked that UCSF
had decided not to seek the testimony of either inventor
on the merits of the conception issue and stated that
UCSF “now lives with that litigation decision.” The
Board also indicated that the passage of time had left
some evidence stale and that memories had faded. For
example, the Board pointed out that there were several
unanswered questions about the ointment that Dr. Leiter
prepared for Dr. Chern; it explained that “no contempora-
neous documents describ[e] exactly how the . . . ‘medica-
tion’ was made,” and it highlighted inconsistencies in Dr.
Leiter’s testimony about the ointment.

     UCSF now appeals, contending that the Board erred
in finding that Dr. Dawson did not conceive of the claimed
inventions by himself prior to his collaboration with Dr.
Bowman. InSite (proceeding as appellee in the name of
Drs. Dawson and Bowman) cross-appeals from the
Board’s failure to rule that all of the claims in UCSF’s
application are unpatentable under 35 U.S.C. §§ 102(b)
and 135(b). At oral argument, we ruled that InSite’s
cross-appeals are inappropriate because they do not
present the prospect of enlarging InSite’s rights or lessen-
ing those of UCSF. See Bailey v. Dart Container Corp. of
Mich., 292 F.3d 1360, 1362 (Fed. Cir. 2002). Accordingly,
we treat the arguments in InSite’s cross-appeals as alter-
native grounds for affirmance and dismiss the cross-
appeals. Because we affirm the Board’s decision on the
DAWSON   v. DAWSON AND BOWMAN                             10
issue of conception, we do not reach those alternative
grounds for affirmance.

                             III

     The definition of conception in patent law has re-
mained essentially unchanged for more than a century. It
is the “‘formation in the mind of the inventor, of a definite
and permanent idea of the complete and operative inven-
tion, as it is hereafter to be applied in practice.’” Hy-
britech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367,
1376 (Fed. Cir. 1986) (quoting 1 Robinson on Patents 532
(1890)). At that point, “all that remains to be accom-
plished, in order to perfect the art or instrument, belongs
to the department of construction, not creation.” 1 Robin-
son 532. Based on that definition, we have held that
“[c]onception is complete only when the idea is so clearly
defined in the inventor’s mind that only ordinary skill
would be necessary to reduce the invention to practice,
without extensive research or experimentation,” and that
“[a]n idea is definite and permanent when the inventor
has a specific, settled idea, a particular solution to the
problem at hand, not just a general goal or research plan
he hopes to pursue.” Burroughs Wellcome Co. v. Barr
Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994). Moreo-
ver, “[b]ecause it is a mental act, courts require corrobo-
rating evidence of a contemporaneous disclosure that
would enable one skilled in the art to make the inven-
tion.” Id.

    Applying these principles, we find no basis for over-
turning the Board’s conclusion that UCSF failed to estab-
lish sole conception by Dr. Dawson. 1 We first note, as the

    1   The dissent states that we erroneously “conclude[]
that Dr. Dawson conceived his invention while working at
InSite.” It is important to bear in mind, however, that we
11                          DAWSON   v. DAWSON AND BOWMAN
Board did, that the nature of the evidence presented in
this case is unusual. We are asked to decide whether and
when an invention formed definitely, permanently, and
particularly in the mind of the alleged inventor, but to do
so without any testimony from the supposed inventor
himself. Instead, UCSF has focused its proof on what
normally serves as corroborating evidence—i.e., contem-
poraneous disclosures of the alleged conception.

    UCSF contends that the WHO Report and the WHO
document prove Dr. Dawson’s conception and that subse-
quent events, most notably Dr. Leiter’s preparation of an
ointment for Dr. Chern, “further corroborate[]” it. We
disagree. At best, as the Board found, the WHO Report
and WHO document announce a general idea,
acknowledge many of the difficulties associated with
making that idea operative, and offer some thoughts on
how one might proceed (including by listing a few poten-
tial delivery vehicles). The WHO document is entitled
“Potential Use of Topical Azithromycin in Trachoma
Control Programmes,” and the WHO Report describes Dr.
Dawson’s presentation as a “preliminary report on the
possibility of developing a topical application of azithro-
mycin,” while “recommend[ing] that [Dr.] Dawson contin-

are reviewing a decision by the Board, not assessing the
evidence in the first instance. The issue of conception
turns in large part on the facts, and we review the Board’s
many factual findings in this case for substantial evi-
dence. In re Gartside, 203 F.3d 1305, 1311-15 (Fed. Cir.
2000). In addition, we are required to assess the Board’s
findings and its ultimate legal conclusion in light of the
burden of proof, which rested on UCSF. As such, we
“conclude” only that substantial evidence supports the
Board’s relevant factual findings and that the Board did
not err in holding that UCSF failed to meet its burden of
proof as to the legal issue of conception.
DAWSON   v. DAWSON AND BOWMAN                            12
ue to work with [others] to develop a topical application
and report back at the next meeting.” A “preliminary”
statement about a “possibility” or “potential use,” along-
side a recommendation for continued work and a “report
back” in the future, falls short of a “‘definite and perma-
nent idea of the complete and operative invention, as it is
hereafter to be applied in practice.’” Hybritech, 802 F.2d
at 1376.

     The inadequacy of UCSF’s showing is equally clear in
the context of the specific interference counts. The limita-
tions of the ’719 count include specific concentrations,
such as “0.01% to 1.0% of an azalide antibiotic” and “0.1
to 10% of a polymeric suspending agent which is a water-
swellable water-insoluble cross-linked carboxy-vinyl
polymer which comprises at least 90% acrylic acid mono-
mers and 0.1% to 5% crosslinking agent.” As the Board
found, UCSF failed to provide “evidence to suggest a
complete conception of th[at] specific formulation.” The
claimed “polymeric suspending agent,” for example, is
said to be Durasite, but nothing in the record shows that
Dr. Dawson knew of those concentration ranges when he
listed Durasite as one of many potential vehicles in his
WHO presentation. Moreover, the Board declined UCSF’s
invitation to “assume that 1999 Durasite® is the same as
1997 Durasite®.”

    Nor did UCSF’s evidence establish conception of the
“0.01% to 1.0% of an azalide antibiotic” to be used in a
suspension. The statement in the WHO document that
“one obvious preparation would be an ointment like the
0.5% erythromycin ointment” and Dr. Chern’s similar
assertion to Dr. Leiter that they wanted to “compare [Dr.
Leiter’s preparation] with erythromycin 0.5% ointment”
do not do so. An “ointment” is not an aqueous “polymeric
suspending agent,” and erythromycin is not an “azalide
antibiotic.” Azithromycin is an azalide antibiotic, but the
Board found “no correlation between a topical formulation
13                           DAWSON   v. DAWSON AND BOWMAN
having 0.5% erythromycin and a topical formulation
having 0.5% azithromycin” during the relevant time
period. See also ’113 patent, col. 3, ll. 53-57 (“Azithromy-
cin is a broad spectrum antibiotic that is generally more
effective in vitro than erythromycin. Moreover, because
azithromycin is an azalide . . . , it exhibits improved acid-
stability, half-life, and cellular uptake in comparison to
erythromycin.”). There would have been no need for Dr.
Chern to send Dr. Bowman “several articles which de-
scribe different concentrations of azithromycin as used in
experimental studies as well as information about the
minimum inhibitory concentrations” if Dr. Dawson had
already known what concentration to use. At bottom, Dr.
Dawson’s idea to develop a product that was “like” anoth-
er product does not establish that Dr. Dawson had a
“specific, settled idea [or] a particular solution” for his
invention. Burroughs, 40 F.3d at 1228; see also Creative
Compounds, LLC v. Starmark Labs., 651 F.3d 1303, 1312
(Fed. Cir. 2011) (“speculat[ion]” that one method “should
be the same” as another method does not show concep-
tion).

      UCSF’s proof was similarly lacking with respect to
the ’729 count. That count calls for “an azalide antibiotic
. . . in an amount effective to treat infection in a tissue of
the eye,” and the Board correctly found that UCSF failed
to establish that Dr. Dawson on his own determined what
that amount was. Both the WHO Report and the WHO
document state that the “[e]fficacy and dosing schedule of
topical azithromycin will need to be determined.” Moreo-
ver, the patents and patent applications all explain that
“in order for a topical application to be effective, the
antibiotic must be able to penetrate the desired tissue.”
E.g., ’113 patent, col. 1, ll. 36-38. The WHO papers make
clear that Dr. Dawson did not know at that time what
that would entail. The documents state, for example, that
“[i]n other tissues, azithromycin has a half-life of 68 to 72
hours, and a similar persistence of the drug may occur in
DAWSON   v. DAWSON AND BOWMAN                               14
the external eye with adequate topical delivery” (empha-
sis added), and “[o]nce a product has been developed, it
must first be tested for pharmacological characteristics
(tissue levels and persistence of drug in conjunctiva).”

    The ointment prepared by Dr. Leiter for Dr. Chern
likewise does not establish, or corroborate, that Dr. Daw-
son on his own conceived of “topically applying an azalide
antibiotic . . . in an amount effective to treat infection in a
tissue of the eye” or of the aqueous suspension covered by
the ’719 count. There is no evidence that Dr. Dawson
instructed Dr. Chern to contact Dr. Leiter or otherwise
had any direct connection to the preparation of the oint-
ment. As the Board found, the evidence also did not
show, for example, that the ointment contained azithro-
mycin “in an amount effective to treat infection in a tissue
of the eye” or “what amount of azithromycin was homoge-
neously distributed in the Leiter-prepared composition or
whether it degraded [or] that any or sufficient azithromy-
cin reached tissue in Chern’s eyes.” As such, the Board
permissibly “decline[d] to accord the Chern testimony and
experimental work much, let alone, controlling weight.”
Dr. Chern’s use of the ointment, with no verified ties to
Dr. Dawson, was mere experimentation, not proof that
the idea of the invention was so clearly defined in Dr.
Dawson’s mind “that only ordinary skill would be neces-
sary to reduce the invention to practice.” Burroughs, 40
F.3d at 1228; see also In re Jolley, 308 F.3d 1317, 1325
(Fed. Cir. 2002) (“if there is no evidence in record that all
of the elements of the count resided in the inventor’s
mind, a noninventor’s testimony cannot supply the miss-
ing pieces”). In sum, we sustain the Board’s conclusions
with respect to the issue of conception in both interference
proceedings.
15                           DAWSON   v. DAWSON AND BOWMAN
                             IV

   UCSF argues that the Board’s decision on conception
was infected by errors in claim construction and the
admission of evidence. We disagree.

    First, UCSF’s claim construction arguments are ei-
ther beside the point or without merit. As to the ’719
count, UCSF argues that the preamble—“[a] process for
treating an eye”—should not be read as limiting, and
that, in any event, the Board erred in construing the
preamble to mean “a process for retarding or suppressing
infection in a tissue of an eye.” UCSF asserts that treat-
ment can be proactive (and thus can occur absent an
active infection) and that the preamble simply recites an
intended use of the invention. The proper meaning and
scope of the preamble, however, is irrelevant to our con-
clusion that UCSF failed to prove sole conception by Dr.
Dawson. As the Board found, UCSF did not show that
Dr. Dawson alone had conceived of the specific concentra-
tions and limitations recited in the body of the ’719 count.
The construction of the term “treating” has no bearing on
that finding.

    UCSF’s complaint about the Board’s construction of
the ’729 count is equally unpersuasive. UCSF focuses on
the “effective amount” requirement but offers different
theories about where the Board went wrong. At various
points, UCSF claims (1) that the Board mistakenly re-
quired that an azalide antibiotic actually treat an infec-
tion in the eye, when all that is required is that it must be
applied in an effective amount, and (2) that applying an
“effective amount” conveys an intended result, but the
count does not require actual efficacy. These arguments
again miss the point. Conception requires an idea to be so
“definite and permanent” that “all that remains to be
accomplished . . . belongs to the department of construc-
tion.” 1 Robinson 532. The WHO Report and the WHO
DAWSON   v. DAWSON AND BOWMAN                            16
document, on which UCSF relies, note that the “[e]fficacy
and dosing schedule of topical azithromycin [still]
need[ed] to be determined,” which undermines UCSF’s
argument that Dr. Dawson had permanently and con-
cretely settled on the effective dosage amounts and how to
achieve efficacy. This case is therefore different from
those cited by UCSF, in which the claims contained
“express dosage amounts [as] material claim limitations,”
Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246
F.3d 1368, 1375 (Fed. Cir. 2001), and in which “efficacy
[wa]s inherent in carrying out the claim steps,” In re
Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012).

     Second, UCSF objects that the Board erred in consid-
ering statements from the specifications of the ’113 and
’443 patents on the ground that those statements were
inadmissible hearsay. As the Board explained, however,
“[a]n admission should not be confused with hearsay,” and
UCSF adopted the words in the ’113 and ’443 patents as
its own when it “‘copied’” those words into the patent
application that provoked these interferences. See Fed. R.
Evid. 801(d)(2)(B) (a statement that a party has adopted
is a party admission and thus is not hearsay). 2

   2     UCSF responds that its statements cannot be
viewed as party admissions because paragraph 152.2.1 of
the Board’s Standing Order provides “that all statements
in a specification are hearsay.” That is incorrect. The
cited portion of the Standing Order states that a specifica-
tion “is admissible as evidence only to prove what the
specification or patent describes” and requires an affidavit
of first-hand knowledge only when “there is data in the
specification upon which a party intends to rely to prove
the truth of the data.” The Board did not rely on any
data, and in any event the provision in the Standing
Order does not address the situation in which statements
17                          DAWSON   v. DAWSON AND BOWMAN
     Third, UCSF argues that the Board “erred in failing
to consider statements made by InSite” to the European
Patent Office (“EPO”). In 2005, InSite opposed an EPO
patent application concerning the topical use of azithro-
mycin as lacking “novelty” and “inventive step.” InSite
argued, in part, that the WHO document “disclos[es] . . .
why topical azithromycin preparations for eye treatment
are highly desirable” and provides “a concrete disclosure
[of] how such preparations can be obtained” and “sugges-
tions [on] how [they] could be made.” Contrary to UCSF’s
assertion, however, the Board did not “fail[] to consider”
that document. Rather, the Board set forth its general
rule against giving controlling weight to documents from
foreign patent proceedings and “decline[d] to give collat-
eral estoppel effect” to the document in this case.

    We hold that the Board did not abuse its discretion in
its ruling on that evidentiary point. See In re Sullivan,
362 F.3d 1324, 1326 (Fed. Cir. 2004). In addition to being
reluctant to place dispositive weight on one document
submitted in a foreign proceeding, the Board properly
noted that this case “deal[s] with conception and actual
reduction to practice . . . not lack of novelty or lack of
inventive step.” In the context of U.S. patent law, this
court has distinguished conception from obviousness,
explaining that the Patent and Trademark Office’s de-
termination that a claimed method was obvious is “irrele-
vant to the question whether the . . . inventors had
conceived of the invention [at a particular point in time].
For conception, we look not to whether one skilled in the
art could have thought of the invention, but whether the
alleged inventors actually had in their minds the required
definite and permanent idea.” Burroughs, 40 F.3d at
1232. InSite’s EPO submission addresses a different

in a party’s specification are used against that party
rather than being offered by that party.
DAWSON   v. DAWSON AND BOWMAN                           18
issue and does not establish whether Dr. Dawson con-
ceived of the complete inventions at issue by himself.

    Finally, UCSF argues that the Board improperly re-
quired a showing of reduction to practice in order to prove
conception. In a replay of arguments made elsewhere,
UCSF’s basic position is that the Board demanded proof
that Dr. Dawson knew his invention would be effective to
treat an actual infection, even though “[a]n inventor need
not know that his invention works to conceive of it as that
is the domain of actual reduction to practice.” UCSF
further contends that Dr. Dawson “did not need to know
that his invention would work to satisfy conception [but]
need[ed] only to have conceived that his topical use of
azithromycin would be effective.” UCSF then argues that
Dr. Dawson “must have” conceived of the inventions
because no medical professional would treat patients with
ineffective doses.

    UCSF’s argument is based on an erroneous view of
what is needed to prove conception. Quite apart from
reduction to practice, conception requires that the inven-
tor know how his “‘definite and permanent idea of the
complete and operative invention . . . is hereafter to be
applied in practice.’” Hybritech, 802 F.2d at 1376. In
other words, part of the conception inquiry asks whether
the inventor “possess[ed] an operative method of making
[the invention].” Invitrogen Corp. v. Clontech Labs., Inc.,
429 F.3d 1052, 1063 (Fed. Cir. 2005). So while UCSF is
correct that “an inventor need not know that his invention
will work for conception to be complete,” Burroughs, 40
F.3d at 1228, there is a critical difference between con-
ceiving a way to make an idea operative and knowing
that a completed invention will work for its intended
purpose. The Board held that UCSF’s evidence of sole
conception by Dr. Dawson was insufficient to prove the
former. We have no reason to overturn that determina-
tion.
19                            DAWSON   v. DAWSON AND BOWMAN
      Each party shall bear its own costs for these appeals.

     Nos. 2012-1214 and -1215, AFFIRMED; Nos. 2012-
               1216 and -1217, DISMISSED
  United States Court of Appeals
      for the Federal Circuit
                 ______________________

                CHANDLER DAWSON,
                     Appellant,

                             v.

    CHANDLER DAWSON AND LYLE BOWMAN,
              Cross-Appellant.

                 ______________________

              2012-1214, -1215, -1216, -1217
          (Interference Nos. 105,719 & 105,729)
                  ______________________

   Appeals from the United States Patent and Trade-
mark Office, Board of Patent Appeals and Interferences.
                ______________________

REYNA, Circuit Judge, dissenting.
    Inventorship is perhaps the most fundamental ques-
tion in patent law. The instant an inventor conceives her
invention is the moment in which vests her right to a
patent, thus perfecting her constitutional right to exclude.
    The question on appeal is whether Dr. Dawson con-
ceived his invention while employed at the University of
California, San Francisco (“UCSF”), or instead after he
joined InSite, a pharmaceutical manufacturer.       The
majority concludes that Dr. Dawson conceived his inven-
tion while working at InSite. I disagree.
2                 CHANDLER DAWSON    v. DAWSON AND BOWMAN
     The record before us demonstrates that Dr. Dawson
possessed a definite and permanent idea of his complete
and operative invention when, in the summer of 1997, he
delivered a related presentation at a conference of the
World Health Organization (“WHO”). At that time, Dr.
Dawson was employed by UCSF, not InSite. Consequent-
ly, I find that Dr. Dawson, through UCSF, satisfied his
burden of demonstrating prior conception. I therefore
respectfully dissent.
                       CONCEPTION
     Conception is the legally operative moment of inven-
tion. It consists of the “formation in the mind of the
inventor, of a definite and permanent idea of the complete
and operative invention, as it is hereafter to be applied in
practice.” Hybritech Inc. v. Monoclonal Antibodies, Inc.,
802 F.2d 1367, 1376 (Fed. Cir. 1986). The law thus rec-
ognizes conception in the instant “when the inventor has
a specific, settled idea, a particular solution to the prob-
lem at hand.” Burroughs Wellcome Co. v. Barr Labs., Inc.,
40 F.3d 1223, 1228 (Fed. Cir. 1994). The inventor’s set-
tled solution must provide the ordinarily skilled artisan
with enough guidance to “understand the invention,” id.,
and its structure, Amgen, Inc. v. Chugai Pharm. Co., 927
F.2d 1200, 1206 (Fed. Cir. 1991). The inventor must be
able to “describe h[er] invention with particularity.”
Burroughs, 40 F.3d at 1228; Amgen, 927 F.2d at 1206
(Conception requires that the inventor “be able to define”
the compound “so as to distinguish it from other materi-
als, and to describe how to obtain it.”). Finally, the inven-
tor must appreciate “the fact of what [s]he made,” Dow
Chem. Co. v. Astro-Valcour, Inc., 267 F.3d 1334, 1341
(Fed. Cir. 2001), that is, she must “appreciate that which
[s]he has invented.” Invitrogen Corp. v. Clontech Labora-
tories, Inc., 429 F.3d 1052, 1063 (Fed. Cir. 2005).
    The facts demonstrate that Dr. Dawson had a settled
idea to solve a particular problem when he gave his
 CHANDLER DAWSON   v. DAWSON AND BOWMAN                 3
presentation at the 1997 WHO conference. Dr. Dawson’s
presentation was entitled, “Potential Use of Topical
Azithromycin in Trachoma Control Programmes,” and it
was accompanied by a report. Dr. Dawson disclosed in his
presentation and report the potential benefits of his new,
topical azithromycin formulation.
     Dr. Dawson presented the problem: “Aqueous (water-
based) eye drops yield a diminished effective dose, and
“azithromycin has a low solubility in aqueous solutions.”
Dr. Dawson then revealed his solution: “[T]here are now
several vehicles that are administered as a drop and
persist in the eye, releasing [the] drug over a long period
of time (Table 1).” He produced a table entitled “Topical
drug delivery to the eye” that identified five such drug
delivery vehicles. The table included Durasite, a delivery
depot comprised of acrylic acid polymers.
     Dr. Dawson further disclosed the effective dosage for
his azithromycin formulation. Dr. Dawson suggested that
his topical azithromycin ointment should use the same
dosage known for erythromycin, an alternative antibiotic
for treating the eye. “[O]ne obvious preparation,” he said,
“would be an ointment like the 0.5% erythromycin oint-
ment.” In the patent Dr. Dawson would later obtain, six
of the fourteen formulations specify precisely this amount,
that is, 0.5%, by weight, azithromycin.
    By February 1998, Dr. Dawson was working with
InSite, presumably to explore commercial production of
his azithromycin ointment. UCSF was unaware of Dr.
Dawson’s collaboration with InSite. In March 1999, Dr.
Dawson and Dr. Bowman of InSite jointly filed a patent
application relating to an azalide antibiotic ointment for
treating infections of the eye. This application matured
into the ’113 and ’443 Patents. Drs. Dawson and Bowman
assigned the ’113 and ’443 Patents to InSite.
    After the patents issued, UCSF provoked an interfer-
ence. UCSF claimed that Dr. Dawson had conceived of
4                 CHANDLER DAWSON    v. DAWSON AND BOWMAN
the patented invention before joining InSite, while still at
UCSF.
                CONCEPTION OF THE COUNT
    In an interference proceeding, a “count” defines the
interfering subject matter and corresponds to a patenta-
ble invention. See Slip Track Sys., Inc. v. Metal-Lite, Inc.,
304 F.3d 1256, 1263 (Fed. Cir. 2002). The party seeking
to establish prior conception must show possession of each
feature recited in the count. Coleman v. Dines, 754 F.2d
353, 359 (Fed. Cir. 1985). Here, the Board defined the
count in the ’729 Interference as follows:
        A process for treating an eye, comprising:
        topically applying an azalide antibiotic to an
    eye in an amount effective to treat infection in a
    tissue of the eye,
    wherein said topically applying comprises supply-
    ing a depot of a composition containing said az-
    alide antibiotic on the eye.
Board Op. 12. Dr. Dawson’s WHO presentation and
accompanying report teach each of the limitations, and
they establish that he had possession of each recited
feature.
     First, both of the WHO references disclose treating an
eye. The WHO presentation recites, “Reasons for local
dosing of the eye,” “effective local dosing of the eye with
one daily treatment or less,” “ocular delivery,” and deliv-
ery depots “that are administered as a drop and persist in
the eye.” Dr. Dawson’s WHO report discloses “ocular
delivery,” delivery depots “that are administered as a drop
and persist in the eye,” and “allowing the drug to be
absorbed by tissues, particularly the conjunctival epithe-
lial cells.”
    Second, both WHO references disclose topically apply-
ing an azalide antibiotic. Azithromycin is an azalide
 CHANDLER DAWSON   v. DAWSON AND BOWMAN                 5
antibiotic. The title of Dr. Dawson’s presentation begins,
“Potential Use of Topical Azithromycin.” The title of the
WHO report is “Alternative Vehicles for Ocular Delivery
of Topical Azithromycin.” 3812. Dr. Dawson’s entire
presentation and accompanying report are directed to
topical delivery of azithromycin, an azalide antibiotic.
    Third, Dr. Dawson’s presentation discloses an effec-
tive dose. Specifically, Dr. Dawson suggested that his
azithromycin formulation would use the same dosage
known for erythromycin. “[O]ne obvious preparation,” he
said, “would be an ointment like the 0.5% erythromycin
ointment.” This dose, that is, 0.5% by weight, is used
throughout Dr. Dawson’s patent as a preferred formula-
tion.
     And fourth, the WHO presentation and report teach
supplying a depot containing the azalide antibiotic. Both
references contain the same table listing five alternative
delivery depots, one of which is Durasite. 1 Both the WHO
presentation and the report disclose “several vehicles that
are administered as a drop and persist in the eye” and
explain that “the advantage of such a preparation is that
the azithromycin would be in contact with the conjunctiva
for a prolonged period of time, allowing the drug to be
absorbed by tissues.” Listing several alternatives, only
one of which is the claimed invention, does not preclude a
finding of conception. See In re Jolley, 308 F.3d 1317,
1322 (Fed. Cir. 2002) (“But [the senior party] admits that
if [the junior party] had proposed in his e-mail a small
number of compounds, such as two esters, one inside and
one outside the count, then [the junior party] would have
established conception of the subject matter of the count-
despite the inclusion of subject matter beyond the scope of

       1   The majority characterizes the five alternative
delivery depots as “many potential vehicles.” Majority
Op. 12.
6                 CHANDLER DAWSON    v. DAWSON AND BOWMAN
the count.”); see also Snitzer v. Etzel, 465 F.2d 899, 902-03
(C.C.P.A. 1972) (“Our principal difficulty with the argu-
ment is that we fail to see the relevance of the listing of
several inoperative species when the species claimed is
operative and performs as ‘speculated.’ Whether it is
labeled ‘discovery’ or ‘speculation,’ appellant's conception
of trivalent ytterbium as a laser-active material is no less
his own, no less original, no less important technological-
ly, and, on this record, earlier than appellees’.”).
    Dr. Dawson’s WHO presentation and the accompany-
ing report disclose each element of at least the ’729 count,
and as such, the two WHO references are sufficient to
demonstrate Dr. Dawson’s prior conception.
           INVENTION IS THE WORK OF THE MIND
    The majority discounts Dr. Dawson’s work at UCSF
as failing to achieve a fully developed idea of the inven-
tion. This conclusion reflects a misapplication of the law
of conception to the facts of this case. To demonstrate
conception, the law does not require that Dr. Dawson
develop a working physical embodiment of his innovative
idea. Indeed,
         Invention is not the work of the hands, but of
    the brain. The man that first conceived the com-
    plete idea by representing it on paper, or by clear
    and undisputed oral explanation, is the first in-
    ventor, and to avail himself of the rights or priori-
    ty the law only requires that he shall use due
    diligence in embodying his idea in a practical
    working machine. The sketch need not be a
    “working drawing.” The conception may be com-
    plete, while further investigation, and perhaps
    experiment, may be necessary in order to embody
    the idea in a useful physical form.
Edison v. Foote, 1871 C.D. 80, 81 (Comm’r Pat. 1871).
While conception thus requires “the formation, in the
 CHANDLER DAWSON   v. DAWSON AND BOWMAN                  7
mind of the inventor, of a definite and permanent idea of
the complete and operative invention,” Mergenthaler v.
Scudder, 11 App. D.C. 264, 276 (D.C. Cir. 1897), it does
not require reduction to practice.
     The point of time at which an invention merits protec-
tion under the patent law is neither when the first
thought occurs, nor when a practical working embodiment
is completed. Rather, conception occurs
   when the ‘embryo’ has taken some definite form in
   mind and seeks deliverance, and when this is evi-
   denced by such description or illustration as to
   demonstrate its completeness. It may still need
   much patience and mechanical skill, and perhaps
   a long series of experiments, to give the concep-
   tion birth in a useful, working form. The true date
   of invention is at the point where the work of the
   inventor ceases and the work of the mechanic be-
   gins.
Cameron & Everett v. Brick, 1871 C.D. 89, 90 (Comm’r
Pat. 1871).
     Here, Dr. Dawson’s WHO presentation manifested an
inventive embryo which thereafter sought deliverance. In
his presentation, he provided a description sufficient to
illustrate the completeness of his invention. All that was
left was the work of the mechanic—that is, reduction to
practice. This Dr. Dawson was not required to do.
                 REDUCTION TO PRACTICE
    After his WHO presentation, Dr. Dawson returned to
UCSF and engaged Dr. Chern, a clinical fellow at UCSF,
to help reduce his azithromycin ointment to practice.
Having already identified Durasite as an appropriate
delivery depot, Dr. Dawson suggested that Dr. Chern
reach out to Dr. Bowman at InSite, the company that
manufactures Durasite.
8                CHANDLER DAWSON    v. DAWSON AND BOWMAN
    Meanwhile, Dr. Chern contacted Mr. Leiter, a phar-
macist and associate of Dr. Dawson, to prepare a topical
azithromycin ointment. Leiter prepared an ointment
using azithromycin and a petroleum depot, and he provid-
ed several tubes of the ointment to Dr. Chern. The tubes
were dated 4 August 1997. Dr. Chern administered the
ointment to his own eye and based on this self-dosage he
confirmed that petroleum depot was an appropriate
vehicle to deliver the topical azithromycin ointment.
    In the interference proceeding, the Board considered
whether Dr. Chern’s experiment showed reduction to
practice before the critical date. The Board held that Dr.
Chern’s experiment could not be reduction to practice
because Chern had not applied the ointment to an actual
infection. The Board based its determination on its
construction of “treating” an eye, which it construed as
“retarding or suppressing infection in a tissue of” an eye.
Because Dr. Chern had not applied the ointment to treat
an actual infection, the Board held that Dr. Chern did not
reduce Dr. Dawson’s invention to practice. The Board
erred in two fundamental aspects. First, the term “treat-
ing an eye” in the preamble of the count is not limiting.
Second, “treating an eye” does not require an actual
infection.
    Generally, a preamble is not limiting “when the claim
body describes a structurally complete invention such
that deletion of the preamble phrase does not affect the
structure or steps of the claimed invention.” Catalina
Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,
809 (Fed. Cir. 2002). Nor is a preamble limiting if it
“merely gives a descriptive name to the set of limitations
in the body of the claim that completely set forth the
invention.” IMS Tech., Inc. v. Haas Automation, Inc., 206
F.3d 1422, 1434-35 (Fed. Cir. 2000).
    Here, the body of the count recites the complete and
operative invention. Indeed the body of the count clarifies
 CHANDLER DAWSON    v. DAWSON AND BOWMAN                    9
what is meant by “treating an eye”: it means “topically
applying an azalide antibiotic to an eye in an amount
effective to treat an infection.” The count does not require
an infection, only an amount effective to treat an infec-
tion.
    Second, even if the preamble is limiting, the correct
construction of “treating an eye” does not require an
actual infection. The specification of the ’113 Patent
explains what is meant by “treating an eye”:
        The present invention relates to a process for
    treating an eye that comprises topically applying
    an azalide antibiotic to an eye in an amount effec-
    tive to treat or prevent infection in a tissue of the
    eye.
’113 Patent col. 2 ll. 3–36. This explanation demonstrates
clearly that “treating an eye” means “topically applying
an azalide antibiotic to an eye.” Although the applied
dose must be “effective to treat or prevent an infection,” an
actual infection is not required. Cf. Abbott Laboratories v.
Baxter Pharm. Products, Inc., 334 F.3d 1274, 1277 (Fed.
Cir. 2003) (noting that “effective amount” has a customary
usage meaning an “amount sufficient” for the intended
result); accord The American Heritage College Dictionary
1440 (3d. ed. 1997) (defining treat as “To subject to a
process, an action, or a change, esp. to a chemical or
physical process or application”); 18 The Oxford English
Dictionary 468 (2d. ed. 1989) (defining treat as “To subject
to a chemical or other physical action; to act upon with
some agent”). The Board’s construction of “treating an
eye” in the ’729 count was clear error. The Board further
erred when it relied on its erroneous claim construction to
discount Dr. Chern’s experiment as evidence of reduction
to practice.
10               CHANDLER DAWSON    v. DAWSON AND BOWMAN
                    POST CONCEPTION
     The question is: because Dr. Dawson’s WHO presen-
tation demonstrated conception and Dr. Chern’s experi-
ment demonstrated reduction to practice, what is left to
establish inventorship? The majority opinion leaves open
for interpretation whether commercialization is required
for full conception.
    But conception does not require commercialization,
nor does commercialization establish initial invention.
On the contrary, the record shows that Dr. Dawson con-
ceived his invention at UCSF. He turned to Dr. Bowman
at InSite only for assistance in commercializing his inven-
tion.
    In February 1998, UCSF submitted a grant proposal
requesting funding from the Edna McConnell Clark
Foundation of New York for a study of trachoma control
strategies. The proposal fully described Dr. Dawson’s
invention: a topical azithromycin ointment using the 0.5%
dosing and Durasite as a delivery vehicle. The proposal
was funded in full. Yet following the proposal, having
finished his inventive work, Dr. Dawson turned to InSite
to commercialize his invention. Naming Dr. Bowman at
InSite as a co-inventor, Dr. Dawson filed a patent applica-
tion covering his invention and assigned his rights to
InSite.
     But nothing in the record indicates an inventive con-
tribution by Dr. Bowman or anyone else at InSite. On the
contrary, the record shows that Dr. Dawson had fully
conceived his invention before he began working with
InSite. UCSF’s grant proposal in particular demonstrates
completion of Dr. Dawson’s inventive work. The record
shows that InSite’s contribution was limited to commer-
cialization. I dare not read this record to take away Dr.
Dawson’s constitutional right to secure his own invention
by virtue of another’s commercialization. To do so would,
among other things, invite mischievous entities to lay
 CHANDLER DAWSON   v. DAWSON AND BOWMAN                 11
hidden along the pathways of discovery, and to waylay
industrious and deserving inventors, by laying claim to
their ingenuities through commercialization. Conception
is fundamental to U.S. patent law, and any changes made
to our law on inventorship should be considered with
caution and foresight.
                       CONCLUSION
    The record in this case belies the majority’s conclusion
that Dr. Dawson conceived his invention while employed
at InSite. Instead, Dr. Dawson’s WHO presentation and
accompanying report demonstrate that, while employed at
UCSF, Dr. Dawson possessed a permanent and definite
idea of his complete and operative invention. I therefore
respectfully dissent.