Ex parte Matson

Board of Patent Appeals and Interferences

Jan 28, 2000

08092543 (B.P.A.I. Jan. 28, 2000)

Application for patent filed Aug. 16, 1993. According to appellant, this application is a1
continuation of application 07/643,541, filed Jan. 18, 1991, which is a continuation-in-part of application
07/274,505 filed Nov. 21, 1988, now U.S. patent no. 5,104,639, issued, Apr. 14, 1992, which is a divisional
of application 06/797,615 filed Nov. 13, 1985, now U.S. patent no. 4,863,873, issued Sep. 5, 1989, which is
a continuation of application 06/670,483 filed Nov. 13, 1984, now abandoned, which is a continuation-in-part
of application 06/579,401 filed Feb. 17, 1984, now U.S. patent no. 4,511,659, issued Apr. 16, 1985, which
is a continuation-in-part of application 06/472,387 filed Mar. 4, 1983, now abandoned, which is a
continuation-in-part of application 06/425,183 filed Sep. 28, 1982, now abandoned, which is a continuation
of application 06/111,917 filed Jan. 14, 1980, now U.S. patent no. 4,404,065, issued Sep. 13, 1983.
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written for
publication in a law journal and (2) is not binding precedent of the Board.
Paper No. 36
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte WAYNE R. MATSON
__________
Appeal No. 1996-3409
Application 08/092,5431
__________
ON BRIEF
__________
Before WINTERS and WILLIAM F. SMITH, Administrative Patent Judges and
McKELVEY Senior Administrative Patent Judge.
WINTERS, Administrative Patent Judge.
Appeal No. 1996-3409
Application No. 08/092,543
2
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of claims 1 through
20, all the claims remaining in the application.
Claims 1 and 10 are representative:
1. In a method for diagnosing disorders in a test individual in which fluid
samples from normal unafflicted control individuals, afflicted abnormal
individuals and said test individuals are analyzed to generate electrical
signal patterns representative of molecular constituents of said samples, the
improvement which comprises creating a data base of electrical signal
patterns representative of frequency distribution of a plurality of
predetermined molecular constituents of fluid samples from an
epidemiologically significant number of individuals having known categories
of disorders and from said unafflicted control individuals, and comparing
said electrical signal patterns in said data base for conformity to electrical
signal patterns representative of frequency distribution of said
predetermined molecular constituents of a fluid sample from said test
individual.
10. A method according to claim 1, wherein said fluid samples comprise
electrochemically active compounds, and wherein each electrical signal
pattern representative of frequency distribution of said plurality of
predetermined constituents of said fluid samples is generated by the
following steps, comprising:
passing each one of said fluid samples separately through a liquid
chromatographic column for achieving time-space separation of the
electrochemically active compounds of said fluid sample eluting in the
column and generating electrical signals representative of the
electrochemical pattern of said fluid sample using an electro-
chemical detection apparatus.
Appeal No. 1996-3409
Application No. 08/092,543
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The references relied on by the examiner are:
Miyagi et al. (Miyagi) 4,338,811 Jul. 13, 1982
Long et al. (Long) 4,343,767 Aug. 10, 1982
Matson (Matson '873) 4,863,873 Sep. 05, 1989
Matson (Matson '639) 5,104,639 Apr. 14, 1992
W.R. Matson, et al. (Matson 1987), "EC ARRAY SENSOR CONCEPTS
AND DTA", Life Sciences, Vol. 41, pgs. 905-908 (1987).
B. Seltzer, et al. (Seltzer), "Fingerprint Pattern Differences in Early- and
Late-Onset Primary Degenerative Dementia", Archives of Neurology, Vol.
43. pgs. 665-668 (1988).
C. Banissi-Sabourdy, et al. (Banissi-Sabourdy), "Electroanalytical
characterization of Alzheimer's disease and ovine spongiform
encephalopathy by repeated cyclic voltammetry at a capillary graphite paste
electrode", J. Electroanal. Chem. vol. 343: section 28, Bioelectrochemistry
and Bioenergetics, pgs. 127-147 (1992).
The claims stand rejected as follows:
I. Claims 1 through 20 under 35 U.S.C. § 112, first paragraph, as based on a
specification which does not provide adequate written descriptive support for the claimed
invention and does not enable any person skilled in the art to make and use the claimed
invention.
II. Claims 1 through 20 under 35 U.S.C. § 112, second paragraph, as indefinite.
III. Claims 1 through 20 under 35 U.S.C. § 103 as unpatentable over Matson 1987
and Seltzer.
Appeal No. 1996-3409
Application No. 08/092,543
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IV. Claims 1 through 20 under 35 U.S.C. § 103 as unpatentable over Miyagi, Long,
Seltzer and the admitted state of the prior art.
V. Claims 1 through 20 under the judicially established doctrine of obviousness-
type double patenting (provisional) as unpatentable over claims 1 through 20 of co-
pending application serial no. 08/105,482.
VI. Claims 1, 2 and 10 under the judicially established doctrine of obviousness-type
double patenting as unpatentable over claims 1 through 4 of U.S. Patent No. 4,863,873.
VII. Claims 1 through 5 and 7 through 10 under the judicially established doctrine of
obviousness-type double patenting as unpatentable over claims 1, 4 through 8, 10, 12
through 16, 18, 19, 22 and 23 of U.S. Patent No. 5,104,639.
We affirm rejection V under the doctrine of obviousness-type double patenting
(provisional), and reverse rejections I through IV, VI and VII.
DISCUSSION
Enablement and Written Description
The claims on appeal are directed to a method of diagnosing disorders by
comparing the electrical signal pattern generated by multiple preselected constituents
Appeal No. 1996-3409
Application No. 08/092,543
5
in a biological sample from a test subject with a data base representative of the frequency
distribution of those same constituents in samples from epidemiologically significant
populations with, and without, that disorder. Some of the claims are limited to diagnosing
Alzheimer’s Disease or Parkinson’s Disease, etc.
The rejection of claims 1 through 20 under 35 U.S.C. § 112, first paragraph, is
based on the written description and enablement requirements of the statute. On
inspection, however, we are unable to identify reasoning which would explain why the
specification does not provide adequate written descriptive support for the claimed
invention. All of the concerns raised by the examiner appear to have a bearing on whether
the claims are based on an enabling disclosure.
It is well settled that the examiner bears the initial burden of providing reasons why a
supporting disclosure does not enable a claim. In re Marzocchi, 439 F.2d 220,
223, 169 USPQ 367, 369 (CCPA 1971). If we can summarize the examiner’s principal
position, it is that undue experimentation would be required to practice the claimed
invention because of the breadth of the claims (“the specification fails to describe in detail
the protocol needed to diagnose any one of the millions of disorders encompassed by the
. . . independent claim. . . . [it] would require an undue amount of experimentation and
follow-up to practice the instant invention for all medical disorders
Appeal No. 1996-3409
Application No. 08/092,543
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known as is encompassed by the instant claims . . ”). See the Examiner’s Answer, pages
4 and 5.
The examiner is further concerned with the absence of certain specific information
(“[t]he specification fails to identify the method used to classify the samples into control and
disease groups . . . [t]he specification fails to teach what level of agreement between a test
individual and a particular disease is required before a classification or diagnosis of a
disease state can be made”). See the Examiner’s Answer, pages 6 and 7.
The claims are indeed broad, and generating a frequency distribution data base for
diseases and/or biological samples encompassed by the claims, but not demonstrated by
working examples, would undoubtedly be time consuming. Nevertheless, the test for
undue experimentation is not merely quantitative. As stated in PPG Indus., Inc. v. Guardian
Indus. Corp., 75 F.3d 1558, 1564, 37 USPQ2d 1618, 1623 (Fed. Cir. 1996):
[T]he question of undue experimentation is a matter of degree. The fact that
some experimentation is necessary does not preclude enablement; what is
required is that the amount of experimentation “must not be unduly
extensive.” Atlas Powder Co., v. E.I. DuPont De Nemours & Co., 750 F.2d
1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984).
The Patent and Trademark Office Board of Appeals summarized this point in Ex parte
Jackson, 217 USPQ 804, 807 (1982):
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Application No. 08/092,543
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The test is not merely quantitative, since a considerable amount of
experimentation is permissible, if it is merely routine or if the specification in
question provides a reasonable amount of guidance with respect to the
direction in which the experimentation should proceed to enable the
determination of how to practice a desired embodiment of the invention
claimed.
Moreover, it is well settled that the specification need not disclose what is well
known in the art. Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1385, 231
USPQ 81, 94 (Fed. Cir. 1986). The examiner has not presented evidence that those
skilled in the art would be unable to identify control and disease populations from which to
generate frequency distribution data bases.
We have carefully reviewed the specification, including the working examples, in
light of the examiner’s commentary on pages 4 through 7 and 16 through 19 of the Answer,
and appellant’s argument on pages 19 through 21 of the Brief and page 4 of the Reply
Brief. We are persuaded that the specification provides adequate guidance enabling any
person skilled in the art to generate frequency distribution databases and to diagnose
disorders in addition to those of the working examples; and that the experimentation
necessary to practice the full scope of the claimed invention, while
considerable, would not be undue. We hold that the examiner has not set forth a
reasonable basis for questioning the enablement of the claims on appeal; accordingly, the
rejection of claims 1 through 20 under 35 U.S.C. § 112, first paragraph, is reversed.
Indefiniteness
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Application No. 08/092,543
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All of the claims on appeal stand rejected as indefinite under 35 U.S.C. § 112,
second paragraph. See the Examiner’s Answer, page 7. To the extent that this rejection
concerns the breadth of certain terms (“‘tumors’, ‘carcinomas’ and ’cardiovascular
diseases’ are indefinite since the specification gives no guidance as to what type of
tumors, carcinomas and cardiovascular diseases are diagnosed by the instant method”),
we are persuaded that one skilled in the art would have no difficulty in
understanding the metes and bounds of these terms; and that “[b]readth is not
indefiniteness.” In re Gardner, 427 F.2d 786, 788, 166 USPQ 138, 140 (CCPA 1970). To
the extent that this rejection concerns the lack of specific information in the claims (“[c]laim
1 is incomplete in that the level of conformity to establish a diagnosis of a particular
disease state is not clearly stated”), we find that the claims are not incomplete when read
in light of the specification.
The rejection of claims 1 through 20 under 35 U.S.C. § 112, second paragraph, is
reversed.
Obviousness
Claims 1 through 20 stand rejected as obvious over Matson 1987 and Seltzer.
Appeal No. 1996-3409
Application No. 08/092,543
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In its broadest aspect, the claimed screening method comprises comparing the
electrical signal pattern generated by multiple preselected constituents in a biological
sample from a test subject with a data base representative of the frequency distribution of
those same constituents in samples from epidemiologically significant populations with,
and without, that disorder.
Matson 1987 teaches that “[c]oulometric electrode series array sensors, coupled
with liquid chromatography (n-ELC), provide a route to multiplying the resolving power of
conventional [liquid chromatography] by factors of 10 to 50.” The reference suggests that
“[t]he use of multiple parameter assays of entire metabolic pathways is potentially
a powerful tool for unraveling mechanisms of disorders . . . and classification of
neurological diseases” and also describes “various techniques of multiple regression and
algorithm construction” as “under investigation.” See the Summary and page 908.
Seltzer discloses frequency distribution analysis of fingerprint patterns (ulner or
radical loops, arches and whorls) to distinguish between early- and late-onset primary
degenerative dementia.
The examiner argues that “[i]t would have been obvious to one of ordinary skill in the
art at the time the invention was made to [have] used a frequency distribution as
Appeal No. 1996-3409
Application No. 08/092,543
As stated in Pro-Mold & Tool Co. v. Great Lakes Plastics, Inc., 75 F.3d 1568, 1573, 37 USPQ2d2
1626, 1629 (Fed. Cir. 1996) (citation omitted), “It is well-established that before a conclusion of obviousness
may be made based on a combination of references, there must have been a reason, suggestion, or
motivation to lead an inventor to combine those references.”
10
taught by Seltzer et al. for the classification of neurological diseases by the Matson ‘87
method because one of skill in the art would have recognized that as taught by Seltzer et
al. the frequency distribution would have shown distinct classifiable differences
between biological markers of controls and individuals with the disease.” See page 8 of
the Answer.
Because fingerprint patterns and metabolic profiles are distinct properties or
features with no readily apparent connection, we infer that the only nexus between Matson
1987 and Seltzer is that both references are concerned with the classification of
neurological disorders. We cannot agree that this alone provides the requisite reason or
suggestion to combine the references in the manner proposed by the examiner. A bare2
assertion that it would have been obvious to analyze any biological sample or parameter
using any statistical model previously used to identify the presence of a neurological
disorder is insufficient. Further, it is apparent from the specification that conventional
mathematical/statistical models are not interchangeable in the claimed method. See the
Specification, pages 17 through 19. The examiner has
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Application No. 08/092,543
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not explained why frequency distribution probability analysis would have been selected
over other models, such as linear regression analysis, stepwise regression analysis, or
cluster analysis, which cannot successfully distinguish between disease and non-disease
populations.
In our judgment, the reason advanced by the examiner for using frequency
distribution analysis in the claimed screening method (“. . . frequency distribution would
have shown distinct classifiable differences . . . “) stems from appellant’s description in the
specification, and not from the prior art. Accordingly, the rejection of claims 1 through 20
under 35 U.S.C. § 103 as unpatentable over Matson 1987 and Seltzer is reversed.
Claims 1 through 20 also stand rejected as obvious over Miyagi, Long, Seltzer and
the admitted state of the prior art.
Miyagi discloses a method of screening for disease by comparing a two-
dimensional pattern diagram representing a test subject’s integrated values of
chromatographic peaks and retention times, with a reference data base of two-
dimensional patterns generated the same way.
Long teaches that liquid chromatography, followed by electrochemical detection
and analysis of the effluent, is conventional. At pages 2 through 5 of the specification,
Appeal No. 1996-3409
Application No. 08/092,543
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appellant indicates that abnormalities in neurotransmitters and related substances are
related to degenerative, neuropsychiatric and behavioral disorders, and that Liquid
Chromatography with Electrochemical Detection (LCEC) is “a common tool for the
determination of . . . metabolites in biological fluids.”
Seltzer discloses frequency distribution analysis of fingerprint patterns (ulner or
radical loops, arches and whorls) to distinguish between early- and late-onset primary
degenerative dementia.
According to the examiner, [i]t would have been obvious to one of ordinary skill in
the art at the time the invention was made to [have] used a frequency distribution as
taught by Seltzer et al. for classification of neurological diseases by the Miyagi et al.
method because one of skill in the art would have recognized that as taught by Seltzer
et al. the frequency distribution would have shown distinct classifiable differences between
biological markers of controls and individuals with the disease. It would have been
obvious to one of ordinary skill in the art to use a conventional method, such as the
electrochemical analysis taught by Applicant and Long et al., for the sample fluid analysis
in the process taught by Miyagi et al. so as to produce patterns which are representative of
the electrochemical constituents in a body fluid which Applicant admits are known to be
associated with various diseases” and “[i]t would have been
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obvious to one of ordinary skill in the art to utilize a known process of analysis for detecting
known constituents associated with a particular disease if one wanted to diagnose that
disease.” See the Examiner’s Answer, the paragraph bridging pages 10 and 11.
We are not persuaded. Again, the specification teaches that
mathematical/statistical models are not interchangeable in the claimed method. The
examiner has not explained why frequency distribution probability analysis would have
been selected over other models, such as linear regression analysis, stepwise regression
analysis, or cluster analysis, which cannot successfully distinguish between disease and
non-disease populations.
Again, we find no reason stemming from the prior art which would have led a
person having ordinary skill to the claimed method. In our judgment, the only reason or
suggestion to combine the references in the manner proposed comes from appellant’s
specification. Accordingly, the rejection of claims 1 through 20 as unpatentable over
Miyagi, Long, Seltzer and the admitted state of the prior art is reversed.
Double Patenting
Claims 1 through 20 have been provisionally rejected under the doctrine of
obviousness-type double patenting over claims 1 through 20 of copending application
Appeal No. 1996-3409
Application No. 08/092,543
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serial no. 08/105,482 (‘482). The present claims are directed to “diagnosis,” while the
claims of the ‘482 application are directed to “screening.” The examiner sets forth the
obviousness relationship between these sets of claims, and provides tenable reasoning
(Examiner’s Answer, paragraph bridging pages 11 and 12). Appellant does not counter
the examiner’s reasoning, arguing only that the limitations “diagnosing disorders in a test
individual,” “fluid samples,” and “predetermined molecular constituents” are not found
verbatim in claim 1 of the ‘482 application and, therefore, that the instant claims “would not
have been anticipated or rendered obvious by claims 1-20 of the ‘482 application.” See
page 27 of the Brief. This general argument does not controvert the examiner’s position
with a reasonable degree of specificity. Accordingly, we affirm the provisional rejection of
claims 1 through 20 under the doctrine of obviousness-type double patenting.
Claims 1, 2 and 10 stand rejected as unpatentable over claims 1 through 4 of U.S.
Patent No. 4,863,873, under the doctrine of obviousness-type double patenting;
claims 1 through 5 and 7 through 10 stand rejected as unpatentable over claims 1, 4
through 8, 10, 12 through 16, 18, 19, 22 and 23 of U.S. Patent No. 5,104,639, on the same
ground. None of the patented claims recites comparison with a frequency distribution
database, nor is that limitation adequately addressed in either rejection.
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Application No. 08/092,543
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Like the rejections under 35 U.S.C. § 103, we find no reason stemming from the patented
claims which would have led a person having ordinary skill to the claimed method. The
rejections of the claims on double patenting grounds over U.S. Patent Nos. 4,863,873 and
5,104,639 are reversed.
No time period for taking any subsequent action in connection with this appeal may
be extended under 37 CFR § 1.136(a).
AFFIRMED
)
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
WILLIAM F. SMITH )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
FRED E. McKELVEY )
Senior Administrative Patent Judge )
vsh
Appeal No. 1996-3409
Application No. 08/092,543
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Norman P. Soloway
Hayes, Soloway, Hennessey & Hage
175 Canal Street
Manchester, NH 03101