Dionne v. Liotta

Dionne v. Liotta, Int. 104,333, Paper 119 (October 31, 2001) [Obviousness – person of ordinary skill in the art, evidence in support]Ptab Interferences

Gesamter Gesetzestext

1
The opinion in support of the decision being
entered today is not binding precedent of the Board.
Paper No. 119
Filed b y: Trial Section Motions Panel
Box Interference Filed: October 31, 2001
Washington, D.C. 20231
Tel: 703-308-9797
Fax: 703-305-0942
UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_______________
GERVAIS DIONNE,
Junior Party,
(Patent 5,538,975),
v.
LIOTTA,
Senior Party
(Application []).
_______________
Patent Interference No. 104,333
_______________
Before: McKELVEY, Senior Administrative Patent Judge, and TORCZON and GARDNER-
LANE, Administrative Patent Judges.
Per curiam.
MEMORANDUM OPINION and ORDER
(Decision on Preliminary Motions)
* * * * *
III. Opinion
A. Construction of the Count
* * * * *
2
In interpreting the claims involved in the interference, we apply the broadest reasonable
meaning of the words in their ordinary usage as they would be understood by one of ordinary
skill in the art, taking into account whatever enlightenment by way of definitions or otherwise
may be afforded by written description contained in applicant's specification. In re Morris, 127
F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). Giving the claims recited in the
count the broadest reasonable meaning, we conclude that one of ordinary skill in the art would
interpret the claims to encompass the (-) FTC enantiomer as well as substantially pure (-) FTC
and their pharmaceutically acceptable salts thereof and pharmaceutical compounds comprising
the (-) FTC enantiomer.
Additionally, we note that Liotta has directed our attention to a Final Decision issued in
Interference 104,201, which is said to hold that a claim directed to the (-) enantiomer of a
compound, without specifying a level of purity covers all mixtures that contain that compound
including a racemic mixture of the (+) and (-) enantiomers. (Liotta Revised Preliminary Motion
1, Paper No. 52, p. 19). The fact that another motions panel in another interference faced with a
different evidentiary record may have reached a different claim construction comes as no surprise
and in any event is entitled to no precedential value. Construction of the meaning of words in a
patent claim is an issue of law to be resolved based on the facts of each case. Markman v.
Westview Instruments, Inc., 52 F.3d 967, 979, 34 USPQ2d 1321, 1329-30 (Fed. Cir. 1995) (in
banc), aff'd 517 U.S. 370, 391, 116 S.Ct. 1384, 1396 (1996) (interpretation of the word
"inventory" [in a patent claim] in this case is an issue for the judge, not the jury * * *."); Ethicon
Endo-Surgery, Inc. v. U.S. Surgical Corp., 93 F.3d 1572, 1577, 40 USPQ2d 1019, 1022 (Fed.
3
Cir. 1996) (significance to be given a limitation in a patent claim is a question of law which is
resolved based on particular facts).
Liotta also directs our attention to In re Williams, 171 F.2d 319, 80 USPQ 150 (CCPA
1948) which is said to hold "that a claim to a laevo optical isomer without mention of a purity
state read on a racemic mixture." (Liotta Reply 1, Paper No. 101, p. 1). Williams, however,
involved a disputed claim directed to a laevo rotary form of a compound that was "substantially
free from the dextro rotary form." Williams does not require a claim construction that a claim to
a laevo optical isomer without mention of a purity state read on a racemic mixture. Moreover,
the U.S. Court of Customs and Patent Appeals ("CCPA") issued words of caution in applying the
Williams holding. Specifically, in the subsequent decision in In re Adamson, 47 CCPA 839, 275
F.2d 952, 125 USPQ 233 (1960), the CCPA indicated that the Williams decision resulted from
the absence of relevant available evidence. In contrast to Williams, the evidence presented in this
interference amply supports our claim construction.
B. Overview of Preliminary and Miscellaneous Motions
* * * * *
1. Dionne Preliminary Motion 3
* * * * *
a. The Person of Ordinary Skill in the Art
There exists a dispute as to knowledge and experience attributed to the "person of
ordinary skill in the art." In particular, Dionne argues for a higher level of skill than that sought
by Liotta. For example, Dionne's experts allege that:
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The subject matter of the '160 Application relates, inter alia, to the synthesis and
resolution of FTC. In my opinion, the person of ordinary skill in the art of the
synthesis and resolution of organic compounds, such as FTC, at all times relevant
to my analyses in this case would be someone with a Ph.D. in organic chemistry
and a minimum of two years further experience in the synthesis and resolution
of organic, medicinal compounds. This person would be experienced in the use
of various resolution techniques, including chromatography (including high
performance liquid chromatography or "HPLC") and/or enzymatic resolution
techniques . . .
(Declaration of Dr. Barry Trost, ¶ 12, DX 2048; see also, Declaration of Dr. Iving W. Wainer,
¶ 4, DX 2155; Second Declaration of Dr. J. Bryan Jones, DX 2144, ¶ 5). In contrast, Liotta
experts argue:
The art to which the '160 application relates is chemistry and, more particularly,
organic chemistry. Based upon my years of experience and knowledge, I believe
that one of ordinary skill in the art would have a B.S. in chemistry (or a related
science) and four or five years of chemical laboratory experience. I do not
believe, as Dionne's declarants suggest, that ordinary skill in the art would
necessarily have been experienced in chiral HPLC and/or enzymes and would
certainly not have been experienced in all resolution techniques.
(LAX 1004, Klibanov Opposition Decl., ¶ 10, emphasis added; see also, Pirkle Opposition Decl.
LAX 1005, ¶ 10).
It is recognized that the person of ordinary skill in the art is a hypothetical person who is
presumed to know the relevant prior art. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc.,
807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986). In determining this skill level, the
Board may consider various factors including "type of problems encountered in the art; prior art
solutions to those problems; rapidity with which innovations are made; sophistication of the
technology; and educational level of active workers in the field." Id. In a given case, every
factor may not be present, and one or more factors may predominate. Id. at 962-63, 1 USPQ2d
at 1201.
5
In support of their allegations, Liotta's experts note that in BioChem Pharma, the real
party in interest in Dionne '975, hired a Ms. Marika DiMarco in 1988 to start up and run the
company's chromatography lab. At that time, Ms. DiMarco had a B.S. in biology and seven years
of industrial experience in chromatography. During the years of 1988 to 1990, Ms. DiMarco was
asked by BioChem Pharma to do research on the resolution of a nucleoside that was related to
FTC. (LAX 1004, ¶ 10; LAX 1005, ¶ 10). Additionally, Dr. Klibanov states that none of the
inventors named in Dionne's or Liotta's applications had the qualifications espoused by Dionne.
(LAX 1004, ¶ 11).
Beyond the conclusory statements of its experts, Dionne has failed to identify sufficient
evidence in support of its alleged skill level. Indeed, Dionne's expert, Dr. Jones has indicated
that techniques for separating the enantiomers in a racemic mixture like FTC have been taught in
undergraduate as well as graduate level organic chemistry courses. (DX 2009, ¶ 16,19 and 25).
Similarly, Dionne's expert, Dr. Wainer has stated that, while working with the FDA (pre-1990),
his goal was to develop a chemical assay for separating the component enantiomers of racemic
mixtures that could be used by an "average chemist" without any type of advanced training. (DX
2040, ¶17). Moreover, Dionne's expert, Dr. Trost states that his lab had obtained separations of
various racemates using chiral HPLC columns with the work being "carried out on a routine basis
by students with Bachelor's degrees in chemistry." (DX 2048, ¶21). Thus, while Liotta's
supporting evidence on this issue is meager, Liotta's evidence combined with the aforementioned
statements of Dionne's experts is arguable sufficient to support a finding that:
One of ordinary skill in the art would have a B.S. in chemistry (or a related
science) and have four or five years of chemical laboratory experience. The
1 Argyropou los v. Swarup, 56 USPQ2d 1795, 1807 (Bd. Pat. App. & Int. 2000) (non-precedential).
6
person of ordinary skill in the art would not necessarily have been experienced in
resolution techniques.
(LAX 1004, ¶ 10; LAX 1005, ¶ 10).
While the foregoing finding may resolve a factual dispute among the parties, its overall
relevance is not apparent. We have noted a tendency for parties involved in interferences to
"define" the level of skill by reference to an academic degree (e.g., a B.S., and M.S. or a Ph.D.)
and/or by reference to a person having a certain number of years of particularized experience
(e.g., in a chemical laboratory). As we have noted on other another occasion,1 the parties
references to degrees and experience are not of much assistance to us as fact-finders. None of the
members of this motions panel has a B.S. degree in chemistry. Even if one of us had such a
degree, we would know only what we think a person with a B.S. in chemistry awarded in the year
we graduated from our particular college might have known.
Likewise, we have no idea what an individual may have learned through four or five years
of chemical laboratory experience. Abstract references to a period of experience are essentially
meaningless. We suppose the precise knowledge acquired as a result of experience might well
be a function of the type of laboratory and the type of work actually done in that laboratory. To
the extent that any member of this panel may have chemical laboratory experience beyond
college, none of it occurred at any time relevant to the issues in this interference.
More to the point is the proposition that our personal understanding of the knowledge of
individuals with a B.S. in chemistry and any number of years of laboratory experience is
essentially irrelevant. Cf. Fromson v. Antiec Printing Plates, Inc., 132 F.3d 1437, 1448, 45
2 Notice Declaring Interference, ¶46.
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USPQ2d 1269, 1277 (Fed. Cir. 1997) (Mayer, C.J., concurring) (I "know" what anodization
means from my own undergraduate studies and experiments; the concept is not difficult and I
need no further education to grasp it. I happen to have a dictionary in my chambers from the era
pertinent here, which would confirm my "knowledge" about anodization. ***. But, I am neither
an expert in the field nor one of ordinary skill in the art despite how much I think I "know" about
a process I once studied. Nor do my colleagues on this court or on the district court possess such
expertise, and even if they did, they would have to defer to the record made in the case.).
As Chief Judge Mayer notes, what counts is what is shown in a record. With respect to
the skill of an ordinary artisan, we believe a party should be able to refer to standard texts and
other publicly available documents to support what a hypothetical person of ordinary skill is
presumed to know. Alternatively, it might be appropriate for a person with knowledge in a
particular field to give testimony with respect to particular facts and techniques known by the
average person working in that field, preferably citing documents in support thereof.
Significantly, the testimony (but not our personal knowledge) may be cross-examined. A party in
an interference cannot be expected to cogently brief an issue and argue its case if it also has to
figure out what our personal knowledge might be.
In evaluating the enablement issues raised in this interference, we have given minimal, if
any, weight to degrees and abstract descriptions of the length of service in chemical laboratories.
Rather, consistent with our requirement that an expert witness state the underlying basis for
opinion,2 we have considered the testimony of the experts on the issue of ordinary skill in the art
8
in light of the technical documents and concrete experience to which those experts have made
reference.
b. The '160 Application Lacks Enablement for the Resolution of FTC
Enantiomers
* * * * *
ii. Prior Art Fails to Enable Chiral HPLC Resolution of FTC
* * * * *
We note that Biochem Pharma, Inc., the real party in interest in Dionne '975, is also
involved in Interference No. 104,369 ("'369"). Specifically, the '369 interference involves
Belleau (real party in interest, Biochem Pharma, Inc.) versus []. The panel that decided the
preliminary motions in '369 interference is the same as in the present interference.
During the '369 interference, Belleau (Biochem Pharama) argued that as of January 3,
1991, one skilled in the art would have been able to obtain the (-)-enantiomer of [] in practically
pure form without undue experimentation. In the '369 interference, this panel concluded that:
Based on the evidence that has been presented to us, we are not convinced that
the amount of experimentation required to obtain (-)-enantiomer, according to
either of the above two [claim] interpretations, would have been undue at the time
the '039 application was filed.
(Interference 104,369, Paper No. 189, Decision on Preliminary Motions, pages 27-28, emphasis
added).
The present interference involves at least one party that was not involved or otherwise
related to the parties involved in the '369 interference. Furthermore, the findings and conclusions
of the '369 decision were based upon a different evidentiary record.
3Dionne has not filed, nor requested to file, a motion seeking the unpatentability of
Liotta's claims under 37 CFR 1.633(a) based upon the art cited in the IDS.
9
To the extent the findings and conclusions of the '369 decision differ from those made in
the present interference, we remind the parties that each interference is decided based on the
specific facts and subject matter in dispute as well as the evidence that is presented during the
interference. Moreover, as a matter of due process, each new party in an interference is entitled
to make its own case. Cf., Blonder-Tongue Laboratories, Inc. v. University of Ill. Foundation,
402 U.S. 313, 169 USPQ 513 (1971).
* * * * *
12. Liotta "Preliminary" Motion 3
Liotta's "Preliminary" Motion 3, in actuality a miscellaneous motion, requests entry of an
order pursuant to 37 CFR § 1.614(c) instructing the examiner of Liotta's '730 application to enter
the Supplemental Amendment and Information Disclosure Statement ("IDS") filed by Liotta
November 17, 1999. Moreover, Liotta requests that the examiner return a signed Form PTO
1449 to Liotta indicating that the references cited in the IDS were considered. (Liotta
Preliminary Motion 3, Paper No. 118, p. 1). This motion is unopposed.
The consideration of an IDS by an examiner and its subsequent entry into Liotta's '730
application file is an ex parte matter. We see no compelling reason for this inter parte
proceeding to be suspended or delayed while the examiner considers the IDS of November 17,
1999.3 After the termination of this interference, the application will be returned to the examiner
for action not inconsistent with action taken by this Board. It is during this ex parte proceeding
that Liotta's IDS should be reviewed and considered.
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Additionally, we note that Liotta's Supplemental Amendment requests that the
specification be amended to reflect claims to certain earlier filed applications. As with the IDS,
the entry of this amendment to the specification is best left for ex parte consideration after the
termination of this interference.
For the reasons provided above, Liotta's "Preliminary" Motion 3 is dismissed without
prejudice to the IDS and amendment being considered when ex parte proceedings resume.
* * * * *
FRED E. McKELVEY )
Senior Administrative Patent Judge )
) BOARD OF PATENT
RICHARD TORCZON ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
SALLY GARDNER-LANE )
Administrative Patent Judge )

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