Bronshtein v. Roser

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_______________
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The opinion in support of the decision being
entered today is not binding precedent of the Board.
Paper 55
Filed by: 	Trial Section Motions Panel
Box Interference 	Filed
Washington, D.C. 	20231
Tel: 	703-308-9797
2 January 2002
Fax: 	703-305-0942
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
VICTOR BRONSHTEIN,
Junior Party,
(Patent 5,766,520),
v.
BRUCE ROSER and ENDA MARTIN GRIBBON,
Senior Party
(Application 08/923,783).
Patent Interference 104,727 (McK)
Before: 	McKELVEY, Senior Administrative Patent Judge, and
SCHAFER and TORCZON, Administrative Patent Judges.
McKELVEY, Senior Administrative Patent Judge.
MEMORANDUM OPINION
(Opinion supporting denial of Bronshtein Preliminary Motion 1)
A. 	Introduction
Bronshtein Preliminary Motion 1 (Paper 22) seeks entry
of judgment of no interference-in-fact. 	37 CFR § 1.633(b). 	If
a preliminary motion for judgment of no interference-in-fact is
granted, then there is no need for a priority determination
because the claims of both parties are patentably distinct from

the claims of the opponent regardless of which claimed invention
was made first. 	Case v. CPC International, Inc., 730 F.2d 745,
750, 221 USPQ 196, 200 (Fed. Cir.), cert. denied, 469 U.S. 872
(1984) (no interference-in-fact means that there is no
interfering subject matter and that a patentee involved patent is
no impediment to granting a patent to applicant with its involved
claims).
Contingent on Bronshtein Preliminary Motion 1 being granted,
Roser Preliminary Motion 1 (Paper 30) seeks to present amended
claims. 	37 CFR § 1.633(i).
In 	MEMORANDUM OPINION and ORDER entered 18 December 2001
(Paper 54), we denied, with prejudice, Bronshtein Preliminary
Motion 1 and we dismissed as moot Roser Preliminary Motion 1.
The following is our opinion in support of our denial of
Bronshtein Preliminary Motion 1.
B. 	Findings of fact
The record supports the following findings by at least a
preponderance of the evidence.1
The interference
1. 	The interference involves a Bronshtein patent
versus a Roser application.
2. 	The junior party is Victor Bronshtein
(Bronshtein).
1 	To the extent these findings of fact discuss legal issues, they may be
treated as conclusions of law.
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3. 	Bronshtein is involved in the interference on the
basis of its U.S. Patent 5,766,520, granted 16 June 1998, based
on application 08/785,473, filed 17 January 1997.
4. 	Bronshtein has been accorded benefit for the
purpose of priority of provisional application 06/021,796, filed
15 July 1996.2
5. 	The real party in interest is Universal
Preservation Technologies, Inc.
6. 	The senior party is Bruce Roser and Enda Martin
Gribbon (Roser).
7. 	Roser is involved in the interference on the basis
of its application 08/923,783, filed 4 September 1997.
8. 	Roser has been accorded benefit for the purpose of
priority of application 08/486,043, filed 7 June 1996.
9. 	The real party in interest is Quadrant Healthcare
(U.K.) Limited, a wholly owned subsidiary of Quadrant Healthcare
PLC (U.K.).
10. 	The count of the interference reads:
Count 1
A method according to claim 1 of Bronshtein patent
5,766,520,
or
a method according to any of claims 10, 12, 47, 48, 82 or 85
of Roser application 08/923,783.
2 	It is noted that the filing date, as printed in U.S. Patent 5,766,520
(item [60]]) is 18 July 1996.
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11. 	The claims of the parties are:
Bronshtein: 	1-14
Roser: 	10, 12, 37-42, 46-48, 82, 85
12. 	The claims of the parties which correspond to
Count 1, and therefore are involved in the interference, are:
Bronshtein: 	1-143
Roser: 	10,4 12, 47, 48, 82, 85
13. 	The claims of the parties which do not correspond
to Count 1, and therefore are not involved in the interference,
are:
Bronshtein: 	None
Roser: 	37-42 and 46
The Bronshtein patent5
14. 	In the summary of the invention, Bronshtein tells
us that (Ex 2002, col. 1, line 65 through col. 2, line 13; bold
added):
the present invention is a method of preserving sensitive
biological suspensions and solutions by forming stable foams
from fluid materials to be dried, as an aid both to the
3 	Bronshtein claims 1 and 3 are reproduced in Findings 20 and Finding 21,
respectively.
4 	Roser claim 10 is reproduced in Finding 24.
5 	The Bronshtein patent has been admitted in evidence only to establish
what is described therein, not to prove the truth of any statement made therein.
See (1) 37 CFR § 1.671(b), (2) Fed. R. Evid. 105 and 802 and (3) § 41 of the
STANDING ORDER applicable to this interference (Paper 2). 	Statements in the
patent are also admitted as admissions against interest as to Bronshtein. 	Fed.
R. Evid. 801(d)(2).
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drying of one or more biologically active substrates in the
fluid and as an aid in preparing an easily soluble dried
product suitable for further commercial use. 	The stable
foams are formed by partially removing water in the
biologically active sample to form a viscous liquid and by
further subjecting the reduced liquid to vacuum to cause it
to "boil" during further drying at temperatures
substantially lower than 100 degrees C. 	In other words,
reduced pressure is applied to viscous solutions or
suspensions of biologically active materials to cause the
solution or suspension to foam during boiling, and during
the foaming process further water removal causes the
ultimate production of a stable open-cell or closed-cell
foam.
15. 	Following up in the detailed description of the
invention, Bronshtein further tells us that the invention
(Ex 2002, col. 2, lines 21-36; bold added):
is a method of preserving sensitive biological dispersions,
suspensions, emulsions and solutions by forming stable foams
from fluid materials to be dried, as an aid both to the
drying of one or more biologically active substrates in the
fluid and as an aid in preparing an easily divisible dried
product suitable for further commercial use. 	The stable
foams are formed by partially removing the water to form
a viscous liquid and by further subjecting the reduced
liquid to vacuum, to cause it to "boil" during further
drying at temperatures substantially lower than 100
degrees C. 	In other words, reduced pressure is applied to
viscous solutions or suspensions of biologically active
materials to cause the solutions or suspensions to foam
during boiling, and during the foaming process further
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solvent removal causes the ultimate production of a stable
open-cell or closed-cell foam.
16. 	Bronshtein goes on to state (col. 3, lines 6-12):
In an important embodiment of the invention, the foam
forming process includes two steps: (a) an intensive
dehydration of the solution or dispersion containing the
biologically active agent by boiling under vacuum, to form a
stable, non-collapsing foam and (b) subsequent secondary
drying of the foams, to the extent that the foams are stable
and do not collapse during storage.
17. 	Bronshtein further goes on to state (Ex 2002,
col. 3, lines 22-24):
In the method of the invention, relatively large amounts
of biologically active liquids (solutions or suspensions)
are dehydrated by boiling under vacuum to form stable foams.
Formation of foams is a kinetic process and depends on the
rate of temperature and vacuum changes during formation of
the foam as well as the initial concentration and
composition of the solution or dispersion containing the
biologically active substance.
18. 	Example 1 describes the following procedure
(Ex 2002, cols. 3 and 4) (material in [brackets] and bold added):
EXAMPLE 1
Aqueous 50% glycerol isocitrate dehydrogenase solution
from Sigma Chemical Co. containing 59.4 units of activity
per ml. was dialyzed for 5 hours in 0.1M TRIS HCl buffer
(pH = 7.4). 	The activity of the isocitrate dehydrogenase in
the 0.1M TRIS HCl solution after dialysis was 26 +/- 1.8
units per ml. 	The activity decrease was associated with
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decrease in the enzyme concentration because of dilution
during the dialysis.
One hundred (100) microliters of the mixture containing
50 microliters of 50% by weight sucrose solution and 50
microliters of the isocitrate dehydrogenase suspension in
0.1M TRIS HCl buffer (pH = 7.4) was placed in 1.5 ml.
plastic tubes and preserved by drying at room temperature.
First, the samples were dried 4 hours under low vacuum
(hydrostatic pressure P = 0.2 atm [150 Torr]). 	Second, the
samples were boiled during 4 hours under high vacuum of
(P < 0.01 atm [7.6 Torr]). 	During this step a stable dry
foam was formed in the tubes. 	Third, the samples were
stored during 8 days over DRIERITE under vacuum at room
temperature.
After the days of storage, the samples were rehydrated
with 500 microliters water. 	Rehydration of the samples
containing dry foams was an easy process that was completed
within several seconds. 	Reconstituted sample was assayed
for activity by assaying ability to reduce NADP, measured
spectrophotometrically at 340 nm. 	The reaction mix
included: 2 ml. 0.1M TRIS HCl buffer, pH = 7.4;
10 microliters of 0.5% by weight NADP+; 10 microliters of
10 mM solution of MnSO4; 10 microliters of 50 mM 1
isocitrate; and 10 microliters of an isocitrate
dehydrogenase solution. The activity was 2.6 +/- 0.2
units/ml. which means there was no loss of activity during
drying and subsequent storage at room temperature.
19. 	Example 2, the only other example in the
Bronshtein patent, describes a process similar to that described
in Example 1 (material in [brackets] and bold added).
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EXAMPLE 2
One Hundred (100) microliters of a mixture containing
50 microliters of 50% by weight sucrose solution and
50 microliters of an ice nucleating bacteria suspension
supplied by Genencor International, Inc. were placed in
1.5 ml. plastic tubes and preserved by drying at room
temperature. 	First, the samples were dried for 4 hours
under low vacuum (hydrostatic pressure P = 0.2 atm
[150 Torr]). 	Second, the samples were boiled during 4 hours
under high vacuum (P<0.01 atm [7.6 Torr]). 	After boiling
under vacuum, a stable dry foam was formed in the tubes.
Third, the samples were stored during 8 days over DRIERITE
under vacuum at room temperature. 	After 8 days of storage
the samples were rehydrated with 500 microliters water.
Rehydration of the samples containing the dry foams was an
easy process that was completed within several seconds.
Then the samples were assayed for ice nucleation activity in
comparison with control samples. 	We found that there was no
significant difference between the ice nucleating activity
per 1,000 bacteria in the samples preserved by the present
method versus the control samples.
20. 	Bronshtein claim 1 reads (Ex 2002, col. 4)
(indentation in original):
A method of shelf preservation of biologically active
materials by drying comprising the
step of subjecting a solution, dispersion or suspension
containing a biologically active agent to a vacuum
corresponding to the remaining hydrostatic
pressure lower than 24 Torr
sufficient to cause said solution, dispersion or
suspension to boil such that said boiled solution,
dispersion or suspension is dried to yield a
mechanically stable foam during boiling.
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21. 	Bronshtein claim 3 reads (Ex 2002, col. 4)
(indentations, matter in [brackets] and bold added):
The method according to claim 1 wherein prior to the
step of subjecting said solution, dispersion or suspension
to a high vacuum said solution, dispersion or suspension is
dehydrated or concentrated
[1] 	by evaporation from liquid state at a low
vacuum corresponding to the remaining hydrostatic
pressure higher than 7.6 Torr or
[2] 	by evaporation from partially frozen state or
[3] 	by concentration by reverse osmosis
or other membrane technologies
to reduce the time during which said high vacuum must be
applied and to increase the viscosity of said solution,
dispersion or suspension before boiling under high vacuum.[6]
The Roser application7
22. 	According to the Roser application (Ex 2004)
(material in [brackets] added):
The present invention encompasses methods of producing
dried foamed glass matrices (FGMs). 	[Page 3, lines 31-32.]
* * *
[O]ne aspect of the invention is methods for producing
FGMs, comprising preparing a mixture comprising at least one
glass matrix-forming material in at least one solvent,
evaporating bulk solvent from the mixture to obtain a syrup,
6 	While it is not an issue before us, it is not apparent to us where
alternatives [2] or [3] are described in the descriptive portion of the
Bronshtein patent.
7 	As in the case of the Bronshtein patent, the Roser application has been
admitted in evidence only to show what is described therein and not to prove the
truth of statements made therein. 	Statements in the application are also
admitted as admissions against interest as to Roser. 	See n.5, supra.
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exposing the syrup to a pressure and temperature sufficient
to cause boiling of the syrup, and optionally removing
residual moisture. 	[Page 4, lines 3-10; see also page 7,
lines 14-20.]
* * *
In the primary drying step, the solvent is evaporated to
obtain a syrup. 	Typically, a "syrup" is defined as a
solution with a viscosity in the region of 106 - 107 Pascal
seconds. 	The syrup is not defined as a fixed concentration,
but is a result of the bulk of the solvent evaporating from
the mixture. 	Typically, a syrup is a viscous mixture
containing the glass matrix-forming material and/or
additives and/or substances, in a significantly higher
concentration than that of the initial mixture. 	The
evaporation step may remove 5-95% of the solvent.[8]
Typically, the evaporation step is conducted under
conditions sufficient to remove about 20% to 90% of the
solvent to obtain a syrup. 	The temperature can be about 0°C
to 80°C, or about 15°C to 60°C, or about 25°C to 45°C.[9]
The viscosity of the syrup is preferably such that when the
syrup boils, evaporation from the increased surface area,
provided by extensive bubble formation, results in its
vitrification. 	[Page 17, lines 8-23.]
* * *
The initial drying step [, i.e., the primary drying
step,] can be performed under pressure less than ambient.
Preferably, the pressure is 0.1 to 30 Torr/mm Hg. 	Even more
preferably, the pressure is 5 to 20 Torr/mm Hg. 	Most
8 	The sentence was added to the specification in an amendment filed
20 November 1996 (Ex 1010, page 2, Amendment entry A1). 	The examiner entered the
amendment. 	Bronshtein has not maintained that the amendment adds "new matter"
(35 U.S.C. § 132).
9 	The sentence was added to the specification in an amendment filed
20 November 1996 (Ex 1010, page 2, Amendment entry A2). 	The examiner entered the
amendment. 	Bronshtein has not maintained that the amendment adds "new matter"
(35 U.S.C. § 132).
- 10

preferably, the pressure is 7.5 to 12.5 Torr/mm Hg and the
external temperature is 40°C. 	[Page 18, lines 9-14.]
* * *
The syrup obtained from the primary drying step is
exposed to a reduced pressure to effect boiling of the
syrup. 	As used *** [in the Roser application], "boiling" is
defined as the point at which the vapor pressure of the
mixture is equal to or exceeds the external pressure to
which the sample is exposed. 	Boiling is evidenced visually
by bubbling as the solvent and/or other volatile components
rapidly vaporize. 	[Page 18, line 33 through page 19,
line 5.]
23. 	Example 3a (Ex 2004, page 25) is typical of one
method described in the Roser application (material in [brackets]
added; underscoring in original):
[Example 3a]
3a. 	Formation from solution of glass matrix-forming
material plus additive
Aliquots of 1 ml or 500¼l of 25%(w/v) trehalose containing
either 0.25 or 0.5 M ammonium bicarbonate, were dried in 10
ml pharmaceutical vials in the FTS drier.[10] 	The 1 ml
samples were dried at a constant vacuum pressure of 0.03
Torr/mm Hg for 14 hrs, with shelf temperature initially
25°C, raised to 45°C after the first 2 hours (i.e., syrup
formed). 	The 500 	 ¼l samples were dried at a constant shelf
temperature of 25°C and a constant vacuum pressure of 0.01
Torr/mm Hg for 14 hr. 	The FGMs formed (Fig. 2A) occupied
larger volumes than identical samples processed by freeze-
drying (Fig. 2B).
1 0 	FTS is described (Ex 2004, page 20, lines 4-7) as the FTS Systems
Inc. (Stone Ridge, New York) Model TDS 00078-A with a VP-62P vacuum pump
and a FD-00057-A condenser module.
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24. 	Roser independent claim 1 reads (indentation in
original and bold added):
A method for producing foamed glass matrices (FGMs)
containing a biologically active agent comprising the steps
of:
(a) 	preparing an initial mixture comprising at least
one glass matrix-forming material containing a biologically
active agent selected from the group consisting of a
therapeutic agent, a prophylactic agent, a pharmaceutically
effective substance and a diagnostic reagent, and an organic
solvent(s) for the glass-matrix forming material;
(b) 	evaporating a portion of the solvent(s) from the
mixture to obtain a syrup;
(c) 	boiling the syrup under less than atmospheric
pressure to produce foaming of the syrup; and
(d) 	continuing step (c) until the boiling results in
the formation of a solid foam and produces a foamed glass
matrix containing the biologically active agent.
Bronshtein Preliminary Motion 1
25. 	In Bronshtein Preliminary Motion 1, Bronshtein
asserts that "[a]through numerous patentable distinctions between
the Roser claims and Bronshtein claims exist, this Preliminary
Motion focuses only on step (b) of Roser ***." 	Thus, as a matter
litigation strategy, Bronshtein bottoms its no interference-in
fact position on the proposition that step (b) in Roser claim 10
means that Roser claim 10 defines an invention which is
separately patentable from all Bronshtein claims, including
Bronshtein claim 3. 	In its opposition (Paper 35, page 15), Roser
notes that "Bronshtein Motion 1 only focuses on one element [sic
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limitation] of Roser's claims." 	We therefore have no occasion to
consider other "distinctions" which Bronshtein may believe exist
between Roser claim 10 and Bronshtein claim 3.
26. 	An interesting feature of Bronshtein Preliminary
Motion 1 is that, contingent on the motion being granted,
Bronshtein will disclaim Bronshtein claim 3.
Roser opposition
27. 	In its opposition (Paper 35), Roser makes the
following observations (material in [brackets] added):
Roser submits that evaporation is inherent in the method
claimed by both parties even though Bronshtein's claims do
not specifically recite evaporation. 	Both parties are
claiming a patentably indistinct process and each set of
claims-in-interference anticipates the other or, in the
alternative, is [sic--would have been] obvious over the
other. 	[Paper 35, page 1.]
* * *
Unfortunately for Bronshtein, the laws of physics make it
impossible for Bronshtein's and Roser's claimed method to be
carried out without evaporation to form a syrup. 	[Paper 35,
page 15.]
Bronshtein's reply
28. 	In its reply (Paper 39), Bronshtein maintains
(page 3, ¶ 11): that [t]he Bronshtein method does not necessarily
evaporate to obtain a syrup at or below boiling point."
The "expert" testimony
29. 	Both parties called "expert" witnesses.
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30. 	Bronshtein did not rely on any expert in filing
Bronshtein Preliminary Motion 1.
31. 	In its opposition (Paper 35), Roser relies on the
declaration testimony of Dr. Geoffrey Lee (Ex 1014). 	Dr. Lee was
cross-examined in London, England (Ex 2022, page 1). 	Senior
Administrative Patent Judge McKelvey presided over Dr. Lee's
cross-examination via teleconference (Ex 2022, pages 5 and 126).
32. 	In its reply (Paper 39), Bronshtein relies on the
declaration testimony of Dr. Vijay Dhir (Ex 2023). 	Dr. Dhir was
cross-examined in Newport Beach, California (Ex 2023, page 3).
Senior Administrative Patent Judge McKelvey presided over
Dr. Dhir's cross-examination via teleconference.
Dr. Lee's testimony
33. 	Roser qualified Dr. Lee as an expert on the use of
vacuum drying to produce stable biological materials embedded in
glasses (Ex 1014, ¶ 3, last sentence).
34. 	In Dr. Lee's opinion, a solution of the type
described by Bronshtein and Roser, "must pass through a 'highly
viscous' state ('syrup') on vacuum drying, otherwise it would be
impossible for it to become a glass" (Ex 1014, ¶ 11, page 7).
35. 	According to Dr. Lee (Ex 1014, ¶ 14, page 8):
Roser describes his drying process in a way that appears to
recite two distinct steps: 	first, formation of a syrup
below the solution's boiling point, and second, boiling of
the syrup under less than atmospheric pressure.
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36. 	Further according to Dr. Lee (Ex 1014, ¶14,
page 8) (material in [brackets] in original):
Bronshtein describes his invention as a drying process in
which the solution is dried by "partially removing the water
to form a viscous liquid [evidently below the boiling point]
and by further subjecting the reduced liquid to vacuum, to
cause it to boil [evidently at the boiling point]."
37. 	Dr. Lee understands the Roser specification as
follows (Ex 1014, ¶ 17, page 10):
The [Roser] specification describes a continuous process of
direct vacuum drying via evaporation. 	The solution is held
under vacuum (0.1 to 30 Torr) to effect evaporation of the
liquid. 	This [evaporation] leads to an increase in
concentration of the dissolved material and a simultaneous
increase in the viscosity of the solution until it has the
appearance of a "syrup." 	Continued application of the same
vacuum eventually causes the product temperature to reach
its boiling point corresponding to the applied vacuum
pressure and temperature. 	This [reaching the boiling point]
occurs because "the reduced mobility of water molecules
through the viscous syrup reduces the rate of evaporative
cooling.
38. 	Dr. Lee understands the Bronshtein specification
as follows (Ex 1014, ¶ 22, page 13) (underscore in original):
In his specification, Bronshtein describes his invention of
removal of water to form a foam as follows: 	"the stable
foams are formed by partially removing the water to form a
viscous liquid and by further subjecting the reduced liquid
to vacuum, to cause it to boil during further drying at
temperatures substantially lower than 100 degrees C."
* * *
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Elsewhere, the Bronshtein patent further states in identical
terms how water is removed from suspensions and solutions of
biologically active materials: 	"[t]he stable foams are
formed by partially removing water in the biologically
active sample to form a viscous liquid and by further
subjecting the reduced liquid to vacuum to cause it to boil
during further drying at temperatures substantially lower
than 100 degrees C."
39. 	According to Dr. Lee (Ex 1014, ¶23, page 13)
(citations to the Bronshtein patent omitted):
Bronshtein does not disclose any methods lacking evaporation
and syrup formation steps prior to boiling. 	The two
illustrative examples in Bronshtein confirm that *** [i]n
both, a solution is first dried for 4 hours under low vacuum
(0.2 atm, equivalent to 152 Torr), after which time the
vacuum pressure is lowered to 0.01 atm (equivalent to 7.6
Torr), to cause boiling. 	***. 	Initially, under low vacuum
the solution does not boil, but progressively loses solvent
via evaporation "to form a viscous liquid ***. 	The
subsequent high vacuum causes the viscous liquid "to boil"
***.
Dr. Dhir's testimony
40. 	Bronshtein qualified Dr. Dhir as an expert on
physicochemical differences between evaporation and boiling
(Ex 2023, ¶ 2, last sentence).
41. 	Most of Dr. Dhir's declaration testimony, and for
that matter his cross-examination, deals with (1) the theoretical
thermodynamics and other subtleties of evaporation and boiling
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and (2) taking on Dr. Lee's qualifications to give opinions about
evaporation and boiling.
42. 	During Dr. Lee's cross-examination a boiling curve
was discussed (Ex 2022, 28:13-46:10). 	Its significance, if any,
to the issues in this case is not entirely clear. 	In any event,
Dr. Dhir notes (Ex 2023, ¶ 8, pages 5-6):
Based on Dr. Lee's gross misinterpretation and obvious
unfamiliarity with the boiling curve (Ex 2022, pgs. 28-43),
an understanding of which is essential to a rigorous
scientific appreciation of the thermodynamics of boiling, it
is my opinion that Dr. Lee lacks the necessary expertise to
provide any credible opinion regarding the physico-chemical
properties of boiling.
43. 	Dr. Dhir goes on to identify "four specific
examples of Dr. Lee's alleged inaccurate and alleged erroneous
interpretations of the boiling curve (Ex 2023, ¶ 8, pages 6-7).
44. 	Dr. Dhir testified (Ex 2023, ¶ 18, page 9):
Roser's contention that Bronshtein's method necessarily
requires formation of a syrup prior to boiling is incorrect
because Bronshtein's claimed method may be carried out by
dissolving solutes in a solvent before boiling.[11]
45. 	Without stating the underlying basis therefor,
Dr. Dhir further testified (Ex 2023, ¶ 21, page 10):
1 1 	It is not apparent, and we have not been told, where the Bronshtein
describes or otherwise discusses the option mentioned by Dr. Dhir.
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There are many solutions of biologically active salts
and dispersions or suspension of viruses or cells that will
not form a syrup during evaporation or boiling.[12]
Resolution of conflicting testimony
46. 	To the extent there is a conflict between the
testimony of Dr. Lee and Dr. Dhir on technical factual issues in
dispute which we find necessary to resolve in deciding Bronshtein
Preliminary Motion 1, we credit the testimony of Dr. Lee and
accord it more weight.13
47. 	Dr. Lee is familiar with the art (i.e., the field
of the invention,) involved, whereas Dr. Dhir does not claim to
be familiar with that art.
48. 	A review of their respective cross-examination
transcripts will reveal that Roser's witness Dr. Lee demeanor was
one of attempting to answer in a forthright manner questions
1 2 	In this respect, attention is directed to § 42 of the STANDING ORDER
(Paper 2) applicable to this interference:
Affidavits expressing an opinion of an expert must disclose the
underlying facts or data upon which the opinion is based. 	See Fed. R.
Evid. 705 and 37 CFR §§ 1.639(b) and 1.671(b).
Opinions expressed without disclosing the underlying facts or data may
be given little, or no, weight. 	See Rohm and Haas Co. v. Brotech Corp.,
127 F.3d 1089, 1092, 44 USPQ2d 1459, 1462 (Fed. Cir. 1997) (nothing in the
Federal Rules of Evidence or Federal Circuit jurisprudence requires the
fact finder to credit the unsupported assertions of an expert witness).
1 3 	In re Inland Steel Co., 265 F.3d 1354, 1366, 60 USPQ2d 1396, 1405-06
(Fed. Cir. 2001) (board is given broad deference in its weighing of the evidence
before it). 	We have weighed and credited conflicting testimony in the same sense
as Semiconductor Energy Laboratory Co. v. Samsung Electronics Co., 4 F.Supp.2d
477, 483 n.8, 46 USPQ2d 1874, 1879 n.8 (E.D. Va. 1998) ("In this regard, and
indeed generally, the Court credits the testimony of Samsung's witnesses
Dr. Fonash, Dr. Tsai, and Dr. Meyerson over SEL's witnesses Dr. Lucovsky and
Dr. Yamazaki whenever there is a conflict."), aff'd, 204 F.3d 1368, 1376, 54
USPQ2d 1001, 1006 (Fed. Cir. 2000) ("As a generally matter, we first note that
the district court found Dr. Yamazaki and SEL's other witnesses to be not
credible. 	Instead, the district court credited the testimony of Samsung's
witnesses over that of SEL's whenever there was a conflict.").
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asked, whereas Bronshtein's witnesses Dr. Dhir often avoided
straightforwardly answering cross-examination questions.
49. 	Moreover, in our judgment, Dr. Lee's testimony on
conflicting factual issues we address and resolve in this opinion
is more consistent with, and more solidly bottomed on, the Roser
and Bronshtein specifications than the corresponding testimony of
Dr. Dhir.14
C. 	Discussion
1. 	The issue
a.
An interference is not declared, unless at the time the
interference is declared, the Director, through the board on
recommendation of a primary examiner, is of the opinion that a
pending application "would interfere" with another pending
application or an unexpired patent. 	35 U.S.C. § 135(a); 37 CFR
§ 1.610(a).
In the opinion of the board, an application interferes with
an unexpired patent when both the application and patent have
claims which are directed to the same patentable invention within
the meaning of 37 CFR § 1.601(n). 	The notice declaring
interference is an interlocutory order presumed to be correct.
37 CFR § 1.655(a). 	Accordingly, when an interference is
declared, a presumption is created that there is an interference
1 4 	To the extent Bronshtein believes it is an issue, we expressly reject
any notion that Dr. Lee is not an objective expert, i.e, that he is biased, based
on his cross-examination which revealed as he has previously served as an expert
for Roser's assignee (2022, 17:4-21:4).
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in-fact between at least one claim of the application and at
least one claim of the patent. 	37 CFR § 1.601(j).
A party in an interference seeking to overcome the
presumption of the existence of an interference-in-fact may file
a preliminary motion for judgment of no interference-in-fact.
37 CFR § 1.633(b), 	The party filing the preliminary motion has
the burden of showing that it is entitled to the relief sought in
the preliminary motion. 	37 CFR § 1.637(a); see also Case v. CPC
International, Inc., 730 F.2d 745, 750, 221 USPQ 196, 200 (Fed.
Cir.), cert. denied, 469 U.S. 872 (1984) (burden is on the party
who contends that there is no interference-in-fact). 	The burden
in a case where the application and patent are "copending" is by
a preponderance of the evidence. 	Cf. Bruning v. Hirose, 161 F.3d
681, 685, 48 USPQ2d 1934, 1937-38 (Fed. Cir. 1998) (the burden of
proof on the issue of patentability of the claims of a patent in
an interference where applications are copending is by a
preponderance of the evidence).
One way for a party to establish that there is no
interference-in-fact between any of its claims and any of its
opponent's claims, is to establish that the subject matter of its
claims (which, for purpose of ruling on the motion, are presumed
to be prior art) do not anticipate or render obvious the subject
matter of any claim of its opponent which have been designated as
corresponding to the count.
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b.
Based on the principles set out above, it becomes manifest
that the issue before the panel is whether Bronshtein has
sustained its burden of establishing by a preponderance of the
evidence that there is no interference-in-fact between any
Bronshtein claim corresponding to the count and any Roser claim
corresponding to the count.
Specifically, the issue is whether Bronshtein has
established that the subject matter of Roser claim 10 is
anticipated or rendered obvious by the subject matter of
Bronshtein claims 1 or 3. 	By virtue of Bronshtein's litigation
position, the issue narrows considerably to whether step (b) in
Roser claim 10 is a limitation which is not anticipated or
rendered obvious by the subject matter of any Bronshtein claim,
including Bronshtein 3, assuming the subject matter of the
Bronshtein claims to be prior art to Roser.15
c.
As part of the debate between the parties, an issue has
surfaced of whether the process claimed by Bronshtein inherently
includes "evaporating a portion of the solvent(s) from the
mixture to obtain a syrup", i.e., step (b) in Roser claim 10.
Bronstein maintains that his claimed process does not
inherently include Roser's step (b) and Roser seems to maintain
otherwise.
1 5 	The parties do not seem to question that the subject matter of Roser
claim 1 would anticipate the subject matter of Bronshtein claim 1.
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To the extent it is an issue in need of resolution, it was
Bronshtein's burden to make out a prima facie case that its
claimed method does not inherently perform Roser step (b) because
Bronshtein has the burden of showing that the subject matter of
its claims does not anticipate the subject matter of any Roser
claim. 	37 CFR § 1.637(a).
d.
In an attempt to help us understand the scope of Bronshtein
claims 1 and 3 and Roser claim 10, both parties offered the
testimony of expert witnesses. 	We have considered the testimony.
Nevertheless, construction of the meaning and scope of a claim is
an issue of law. 	See Markman v. Westview Instruments, Inc., 517
U.S. 370, 391, 116 S.Ct. 1384, 1396 (1996) (we hold that
interpretation of the word "inventory" [in a patent claim] in
this case is an issue for the judge, not the jury ***.") and
Kraft Foods Inc. v. International Trading Co., 203 F.3d 1362,
1366, 53 USPQ2d 1814, 1817 (Fed. Cir. 2000), which notes:
Claim construction is a question of law. 	In
interpreting language in a claim, one should look first
to the intrinsic evidence of record, i.e., the patent
itself, including the claims, the specification and, if
in evidence, the prosecution history. 	Within this
intrinsic evidence, the appropriate starting point is
always the language of the claim itself. 	A claim term
should be given its ordinary meaning unless the
specification or prosecution history provide a special,
different meaning or definition. 	There is a heavy
presumption in favor of the ordinary meaning of claim
- 22

language. 	Any special definition given to a word must
be clearly defined in the specification.
We want all to know that we have considered that testimony
in light of the principles announced in Markman and Kraft Foods
and other post-Markman precedent of the Federal Circuit. 	In
essence, we have given weight to the "expert" testimony only to
extent it helps us understand factual issues of a technical
nature. 	As noted earlier, to the extent there is a conflict, we
credit the testimony of Dr. Lee.
2. 	Scope of Bronshtein claims 1 and 3
Resolution of the interference-in-fact issue turns largely
on the scope and meaning of Bronshtein claims 1 and 3.
Bronshtein claim 3 is a dependent claim which sets out three
alternative process steps to be incorporated into the process of
Bronshtein claim 1. 	We believe it useful to re-write Bronshtein
dependent claim 3 in independent form limited to the first of the
three alternative steps16 set out in Bronshtein claim 3
(indentation and material in [brackets] added; material in
strikeout deleted).
Bronshtein claim 3 rewritten in independent form
A method of shelf preservation of biologically active
materials by drying comprising the step [steps] of
[1] 	subjecting a solution, dispersion or
suspension containing a biologically active
agent to dehydration or concentration by
1 6 	See Finding 21, alternative [1].
- 23

evaporating from liquid state at a low vacuum
corresponding to the hydrostatic pressure
higher than 7.6 Torr
[i] 	to reduce the time during which
said [a] high vacuum [as set out in
step [2]] must be applied and
[ii] 	to increase the viscosity of said
solution, dispersion or suspension
before boiling under high vacuum
[as set out in step [2] and
thereafter]
[2] 	subjecting a [the] solution, dispersion or
suspension [of step [1]] to a vacuum
corresponding to the remaining hydrostatic
pressure lower than 24 Torr sufficient to
cause said solution, dispersion or suspension
[of step [1]] to boil such that said boiled
solution, dispersion or suspension [of step
[2]] is dried to yield a mechanically stable
foam during boiling.
3. 	Anticipation
To establish anticipation, a moving party must show that a
prior art reference discloses every limitation of the claimed
invention, either explicitly or inherently. 	Atlas Powder Co. v.
IRECO Inc., 190 F.3d 1342, 1346, 51 USPQ2d 1943, 1945-46 (Fed.
Cir. 1999); In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429,
1431 (Fed. Cir. 1997). 	Accordingly, for Bronshtein to establish
that the subject matter of its claims 1 and 3 does not anticipate
the subject matter of Roser claim 10, Bronshtein must show that
- 24

the subject matter of its claims 1 and 3 does not disclose every
limitation of Roser claim 10, either explicitly or inherently.
Inherency is a question of fact. 	In re Schreiber, supra, In
re Fracalossi, 681 F.2d 792, 794, 215 USPQ 569, 571 (CCPA 1982).
To establish inherency, the extrinsic evidence must make clear
that the missing descriptive matter is necessarily present in the
thing described in the reference, and that it would be so
recognized by persons of ordinary skill; inherency, however, may
not be established by probabilities or possibilities. 	The mere
fact that a certain thing may result from a given set of
circumstances is not sufficient. 	See Continental Can Co. v.
Monsanto Co., 948 F.2d 1264, 1268-69, 20 USPQ2d 1746, 1749 (Fed.
Cir. 1991).
Dr. Lee is of the opinion, as a matter of technical fact,
that a solution of the type described by Bronshtein and Roser,
"must pass through a 'highly viscous' state ('syrup') on vacuum
drying, otherwise it would be impossible for it to become a
glass" (Finding 34; Ex 1014, ¶ 11, page 7). 	There was an attempt
to undermine Dr. Lee's opinion during cross-examination.
According to Bronshtein (Paper 39, pages 3, ¶ 11) (underscore and
bold in original; italics added):
The Bronshtein method does not necessarily evaporate to
obtain a syrup at or below the boiling point. 	Instead,
samples may be subjected to "a vacuum ... sufficient to
cause said solution, dispersion or suspension to
immediately boil ... [i.e., above the boiling point]".
Dr. Lee admitted that this was possible on cross
- 25

examination (Ex. 2022, pgs 102 at 19-22 and pg. 103
at 23-25).
In our opinion, Bronshtein failed to undermine the
credibility of Dr. Lee's opinion on cross-examination. 	The Lee
cross-examination testimony to which Bronshtein directs our
attention has been evaluated in its surrounding context (Ex 2022,
98:3-107:1217). 	In plain English what Dr. Lee said is that one
might be able to immediately boil a solution of the type
described by Bronshtein or Roser: 	"It could happen. 	I would not
be surprised but I am trying to get an elegant product that has a
stable foam" (Ex 2022, 103:23-25). 	As noted earlier in his
testimony, Dr. Lee testifies (Ex 2022, 102:19 through 103:5)
Q. 	[By counsel for Bronshtein]. 	In your opinion, it
is impossible to pull a hard vacuum on a syrup
immediately to bring it to a boil?
A. 	Of course you can do that but it would start to
bump and you would start to lose material which is
thrown out of the solution on to the insides of
the wall and that compromises what is called
"pharmaceutical elegance" and also would be very
detrimental to foam formation because your product
is being thrown out of the solution and that needs
to be avoided.
We believe Dr. Lee's testimony is properly understood to say
that theoretically one could immediately boil a solution, and
therefore there would be no evaporation step, but you will not
1 7 	The cited cross-examination is a question and answer session between
Dr. Lee and the presiding judge, followed by follow-up questions by counsel for
Bronshtein (Ex 2022; 101:8 et seq.).
- 26

get a stable foam. 	The object of the Bronshtein and Roser
inventions is to get a stable foam. 	Hence, the fact that one
might be able to "inefficiently" boil without evaporation becomes
essentially irrelevant in context of the object of the invention
of Bronshtein claim 3, as reproduced above. 	Dr. Lee's testimony
is manifestly credible given the context of the inventions
described in the Bronshtein and Roser specifications and
Bronshtein's explicit disclosure that an evaporation steps leads
to a viscous solution and all examples in the Bronshtein
specification have an evaporation step ("samples were dried").18
Dr. Dhir disagrees (Finding 45). 	As noted earlier, however,
Dr. Dhir has not favored us with the underlying basis for his
opinion. 	What is plain is that his opinion has not been shown to
be based on the invention described in the Bronshtein patent,
including for example Bronshtein Examples 1 and 2. 	Dr. Dhir did
not convincingly explain why the "viscous" liquid described by
Bronshtein (Findings 14 and 15) is not a syrup within the meaning
of a syrup as described in Roser's specification. 	Basically,
Dr. Dhir's opinion amounts to an opinion based on the existence
of a theoretical possibility not confined to the invention before
us.
For the reasons given, we decline to find that Bronshtein
has established that the subject matter of Bronshtein 3,
1 8 	Although it had every opportunity to do so, Bronshtein did not reproduce
Bronshtein Examples 1 and 2 to attempt to demonstrate that a syrup, within the
meaning of Roser claim 10 step (b), is not produced at some point in the process
of going from a solution to a stable foam.
- 27

reproduced above in independent form, fails to anticipate by
inherency Roser claim 10.
4. 	Obviousness
Assuming arguendo that Bronshtein had sustained its
"no anticipation" burden, we hold that Bronshtein failed to
sustain its burden of establishing that the subject matter
of Bronshtein 3, as reproduced above, would not have rendered
obvious the subject matter of Roser claim 10.
Roser claim 10 step (b), the only limitation in issue, calls
for evaporation to obtain a syrup. 	Bronshtein claim 3, as
reproduced above, calls for "dehydration or concentration by
evaporating from liquid state at a low vacuum corresponding to
the hydrostatic pressure higher than 7.6 Torr *** [ii] to
increase the viscosity of said solution, dispersion or suspension
before boiling under high vacuum ***." 	We are at a loss to see
how Bronshtein has established that the subject matter of its
claim 3 would not have rendered obvious the subject matter of
Roser claim 10, including Roser step (b).
We have had considerable difficulty finding that there is in
fact a difference. 	Accordingly, we have difficulty articulating
the precise difference, if any, between the subject matter of
Bronshtein claim 3 and Roser claim 10. 	Bronshtein claim 3, as
reproduced above in alternative [1], calls for an evaporation
step at a pressure higher than 7.6 Torr (Finding 21). 	According
to Bronshtein Examples 1 and 2, evaporation occurs at room
temperature. 	Roser's initial drying step may take place "most
- 28

preferably" at a pressure of 7.5 to 12.5 Torr at a temperature of
0°C to 80°C (Finding 22). 	Thus, Roser and Bronshtein describe
overlapping evaporation conditions. 	Roser tells us that syrup
"typically" is defined as having viscosity of 106 - 107 Pascal
seconds. 	Bronshtein does not tell the viscosity of its "viscous
liquid." 	Roser also tells us that the evaporation step may
remove from 5-95% of the solvent (Finding 22). 	Bronshtein does
not describe the amount of solvent removed during its evaporation
step. 	But, if one uses the same temperature and pressure to
partially evaporate the same solution to obtain a "viscous
liquid" or a syrup, the viscous liquid and syrup start to look
like the same thing. 	We are reminded of the adage that if it has
webbed feet, a bill, feathers, wings, can swim and fly and quacks
like a duck, there is an excellent chance it is a duck.
If one assumes, for purpose of discussion, that the subject
matter of Roser claim 10 differs from that of Bronshtein claim 3,
as reproduced above, then the difference has to be that
Bronshtein's "viscous liquid" is not a syrup within the meaning
of Roser claim 10. 	But, both Bronshtein and Roser contemplate
evaporation of a solution, dispersion or suspension to obtain
something more viscous than the original solution, dispersion or
suspension subjected to evaporation. 	The viscous liquid is then
boiled to obtain a stable foam--a result sought by both
Bronshtein and Roser. 	Bronshtein has not told us, in the context
of the inventions described and claimed by Bronshtein and Roser,
why one skilled in the art would not have been able, and
- 29

motivated, to follow both the Bronshtein and Roser teachings to
evaporate in such a manner as to obtain a suitable "viscous
liquid" or syrup which would then be subjected to boiling to
obtain a suitable stable foam. 	Dr. Lee's cross-examination
discussed above makes it clear that the idea is to get a stable
foam (Ex 2022, 103:23-25). 	Thus, given the subject matter of
Bronshtein claim 3, as reproduced above, Bronshtein has failed,
as was its burden, to show why the subject matter of Roser
claim 10 would not have been obvious.
D. 	Order
We have considered all arguments made by the parties. 	Upon
consideration of Bronshtein Preliminary Motion 1 and Roser
Preliminary Motion 1, and for the reasons given, it is
ORDERED that Bronshtein Preliminary Motion 1 is denied,
with prejudice.
FURTHER ORDERED that the Bronshtein offer to disclaim
Bronshtein claim 3 is dismissed.
FURTHER ORDERED that the time for seeking
reconsideration of our decision denying Bronshtein Preliminary
Motion 1 shall be fourteen (14) days after entry of this
MEMORANDUM OPINION and ORDER.
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FURTHER ORDERED that Roser Preliminary Motion 1 is
dismissed without prejudice as moot.
FRED E. McKELVEY, Senior 	)
Administrative Patent Judge 	)
)
RICHARD E. SCHAFER 	) BOARD OF PATENT
Administrative Patent Judge 	) 	APPEALS AND
) INTERFERENCES
RICHARD TORCZON 	)
Administrative Patent Judge 	)
cc (via Federal Express):
Attorney for Bronshtein
(real party in interest
Universal Preservation Technologies, Inc.):
Daniel E. Altman, Esq.
Brenton R. Babcock, Esq.
Mark R. Benedict, Esq.
KNOBBE MARTENS OLSON & BEAR LLP
Attorney for Roser
(real party in interest
Quadrant Healthcare (U.K.) Limited,
a wholly owned subsidiary of
Quadrant Healthcare PLC (U.K.):
Debra A. Shetka, Esq.
Thomas E. Ciotti, Esq.
Madeline I. Johnston, Esq.
MORRISON & FOERSTER, LLP
- 31