Ex Parte Matson

Patent Trial and Appeal Board

Sep 24, 2018

14321569 (P.T.A.B. Sep. 24, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/321,569 07/01/2014 Wayne R. Matson
27667 7590 09/26/2018
HA YES SOLOWAY P.C.
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
IXC 13.01/03 3523
EXAMINER
4640 E. Skyline Drive WISE, OLIVIA M.
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ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
09/26/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WAYNER. MATSON 1
Appeal2017-010336
Application 14/321,569
Technology Center 1600
Before ERIC B. GRIMES, RYAN H. FLAX, and DAVID COTTA,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of determining metabolomic interactions, which have been rejected as being
obvious and directed to patent-ineligible subject matter. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
The Specification discloses "a method of determining prot[ e Jome[-]
metabolome genome[-]metabolome transcriptome interactions[,] which
1 Appellant identifies the Real Party in Interest as Ixcela, Inc. Appeal Br. 2.
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Application 14/321,569
comprises profiling [the] distribution of coordinately bound metabolome as a
function of the specific individual or class of fractions in a body sample."
Spec. 5:4--7.
Claims 10, 11, and 13 are on appeal. Claim 10 is illustrative and
reads as follows:
Claim 10: A method of determining metabolomic interactions
with at least one of a proteome, genome and transcriptome
within a body system or organ of interest of an individual, the
method comprising the steps of:
(A) obtaining a first body sample from the individual;
(B) performing a first measurement on the first body
sample, using a multi-electrode Liquid Chromatography with
Electrochemical Detection (LCEC) array, of a level of at least
one metabolite coordinately bound to a macromolecule in a
periphery of the body system or organ of interest as a function
of the level of a fraction or class of fractions in the periphery of
the body system or organ of interest from said first body sample
of said individual;
(C) obtaining a second body sample from said individual;
(D) performing a second measurement on the second
body sample, using a multi-electrode LCEC array, of a level of
at least one metabolite covalently bound to a macromolecule in
the proteome of the body system or organ of interest or
covalently or coordinately bound to a macromolecule in the
genome or transcriptome of the body system or organ of
interest;
(E) performing a first mapping, based on said first and
second measurements, of correlative relationships of the levels
of said at least one metabolite measured in step (B) and said at
least one metabolite measured in step (D) as a function of the
level of the fraction or class of fractions in the first body sample
and in the second body sample;
(F) repeating steps (A), (B), (C) and (D) using additional
first and second body samples from additional individuals; and
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(G) performing a second mapping, based on said repeated
measurement steps Band (D), of correlative relationships of the
levels of said at least one metabolite measured in said repeated
measurement step (B) and said at least one metabolite measured
in said repeated measurement step (D) as a function of the level
of the fraction or class of fractions in said additional first and
said additional second body samples.
The claims stand rejected as follows:
Claims 10, 11, and 13 under 35 U.S.C. § I03(a) as obvious based on
Adourian,2 Matson '659, 3 and Matson '4694 (Ans. 5), and
Claims 10, 11, and 13 under 35 U.S.C. § 101 as being directed to a
judicial exception (Ans. 2).
I
The Examiner has rejected all of the claims on appeal as obvious
based on Adourian, Matson '659, and Matson '469. The Examiner finds that
Adourian teaches a method meeting most of the limitations of claim 10
(Ans. 5---6), but does not teach "using a multi-electrode LCEC array to
measure levels of metabolites coordinately or covalently bound to
macromolecules" (id. at 7).
The Examiner finds, however, that "performing measurements on
biological samples using a multielectrode LCEC array of the level of
metabolites covalently or coordinately bound to a macromolecule was
known in the art at the time of the effective filing date of the invention, as
taught by Matson ['659] ... , which is evidenced by Matson ['469]." Id.
2 US 2011/0010099 Al, published Jan. 13, 2011.
3 US 4,511,659, issued Apr. 16, 1985.
4 US 2013/0267469 Al, published Oct. 10, 2013.
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"[S]pecifically, Matson ['469] teaches using the LC-EC array and the ability
to measure the levels of both coordinate and covalent bound metabolites
(Fig. 20; para [0061]) according to U.S. Patent 6,210,970." Id.
The Examiner concludes that the method of the claims on appeal
would have been obvious because
Adourian et al. teach a method for determining correlations
between data features in proteome, genome, transcriptome and
metabolome profiles wherein measurements can be obtained by
any analytical technique that generates or provides data that is
useful in the analysis of a state of a biological system ....
Matson ['659] teaches an analytical technique that provides a
means of measuring metabolite levels in body fluids.
Therefore, one of ordinary skill in the art would recognized that
the LCEC array apparatus taught by Matson (['659] could be
utilized to obtained metabolite level data for the system
profiling method taught by Adourian et al. Furthermore, one of
ordinary skill in the art would predict the data obtained from the
LCEC array taught by Matson ['659] could be readily added to
the correlation analysis method of Adourian et al with a
reasonable expectation of success.
Id. at 7-8.
Appellant argues that Adourian does not teach several of the
limitations of the claimed method, including
measuring the level of at least one metabolite either (a)
covalently bound to a macromolecule in the proteome of the
body system or organ of interest or (b) covalently or
coordinately bound to a macromolecule in the genome or
transcriptome of the body system or organ of interest from a
second body sample, and mapping the correlative relationships
using the levels obtained, as required by independent claim 10.
Appeal Br. 15. Appellant also argues that
there is no teaching or suggestion within the four comers of
Adourian of using measurements as described by Matson and
identifying physical measurable changes in correlations in
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Id.
biochemical networks between metabolite levels in a body
system/organ of interest and a periphery body system/organ of
interest, as required by Applicant's claims. Neither cited
Matson reference cures this deficiency.
We agree with Appellant that the Examiner has not pointed to
evidence in the record that a method meeting all of the limitations of claim
10 would have been obvious based on the cited references. The Examiner
acknowledges that Adourian does not teach "measur[ing] levels of
metabolites coordinately or covalently bound to macromolecules in steps (b)
and (d) of claim 10." Ans. 7. The Examiner cites Matson '469 as
"teach[ing] using the LC-EC array and the ability to measure the levels of
both coordinate and covalent bound metabolites (Fig. 20; para [0061])
according to U.S. Patent 6,210,970." Ans. 7.
Figure 20 of Matson '469 shows "the isotopic patterns of both the
covalent and non-covalent forms ofkynuric acid." Matson '469 ,r 203.
More specifically, Matson '469 states that its Figure 19 shows "four mass
spectra .... Binding occurs when a Fenton reaction occurs in the presence
ofI3PA [indole-3-propionic acid] and ubiquitin." Id. ,r 202. Matson '469
states that
[b ]ased on a comparison of the isotopic patterns of the peaks in
FIG. 19 to the theoretical isotopic distributions of both the
covalent and non-covalent adducts of kynuric acid to ubiquitin,
it is believed that the circled clusters of peaks correspond to two
different binding types. The first ... corresponds to covalently
bound kynuric acid. The second ... corresponds to residual co-
coordinately bound kynuric acid.
Id. ,I 203.
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The Examiner, however, has not pointed to any disclosure in Matson
'469 or any other reference that would give a person of ordinary skill in the
art a reason to measure a "metabolite coordinately bound to a
macromolecule in a periphery of the body system or organ of interest" in a
first sample, and also to measure a "metabolite covalently bound to a
macromolecule in the proteome of the body system or organ of interest or
covalently or coordinately bound to a macromolecule in the genome or
transcriptome of the body system or organ of interest" in a second sample
from the same individual, as required by claim 10.
Thus, because the Examiner has not shown that a method meeting all
of the limitations of claim 10 would have been obvious based on the cited
references, we reverse the rejection of claim 10, and dependent claims 11
and 13, under 35 U.S.C. § 103(a).
II
The Examiner has rejected all of the claims on appeal on the basis that
they are "directed to a judicial exception (i.e., a law of nature, a natural
phenomenon, or an abstract idea) without significantly more." Ans. 2. The
Examiner finds that the claims "recite the judicial exception that is the
abstract idea of mapping correlative relationships" (id. at 3) and "additional
elements that equate to well-understood, routine and conventional activities"
(id.) and "[t]hus, the claims do not amount to significantly more than the
judicial exception itself' (id. at 5).
We agree with the Examiner that claim 10 is directed to a patent-
ineligible method. The Supreme Court has
set forth a framework for distinguishing patents that claim laws
of nature, natural phenomena, and abstract ideas from those that
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claim patent-eligible applications of those concepts. First, we
determine whether the claims at issue are directed to one of
those patent-ineligible concepts. If so, we then ask, "[ w ]hat
else is there in the claims before us?" To answer that question,
we consider the elements of each claim both individually and
"as an ordered combination" to determine whether the
additional elements "transform the nature of the claim" into a
patent-eligible application.
Alice Corp. Pty. Ltd. v. CLS Banklnt'l, 134 S. Ct. 2347, 2355 (2014)
( citations omitted).
Here, claim 10 is directed to the abstract idea of determining
correlations between metabolite interactions with macromolecules in
different individuals. So the next question is, what else is there in the claims
before us?
LCEC has been in the prior art since at least 1985, when Matson '659
was issued. Matson '659, in fact, states that "[i]n recent years, LCEC
(Liquid Chromatography with Electrochemical Detection) has become a
common tool for the determination of catecholamines and their metabolites
in biological fluids." Matson '659 1: 18-21. In essence, the method of claim
10 amounts to no more than applying the existing-routine and
conventional-technique of LCEC to different kinds of data: "a level of at
least one metabolite coordinately bound to a macromolecule in a periphery
of the body system or organ of interest" and "a level of at least one
metabolite covalently bound to a macromolecule in the proteome of the body
system or organ of interest or covalently or coordinately bound to a
macromolecule in the genome or transcriptome of the body system or organ
of interest," and then determining correlations between the measurements.
Claim 10.
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The U.S. Court of Appeals for the Federal Circuit has "treated
collecting information, including when limited to particular content ( which
does not change its character as information), as within the realm of abstract
ideas." Electric Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed.
Cir. 2016). The court has also "treated analyzing information by steps
people go through in their minds, or by mathematical algorithms, without
more, as essentially mental processes within the abstract-idea category." Id.
at 1354. Here, as in Electric Power Group,
Id.
the claims are clearly focused on the combination of those
abstract-idea processes. The advance they purport to make is a
process of gathering and analyzing information of a specified
content ... and not any particular assertedly inventive
technology for performing those functions. They are therefore
directed to an abstract idea.
Appellant argues that
[ w ]hile the claims do recite some steps of measuring samples
and analyzing results, this is not where the inventor[] stopped
inventing nor is this what Appellant seeks to patent. Rather, the
inventor discovered specific methods that include obtaining
body samples from at least two distinct regions (e.g., one from
a periphery of the body system/organ of interest and another
from the body system/ organ of interest), measuring these
samples for a particular feature (e.g., the level of at least one
metabolite covalently or coordinately bound to a
macromolecule), mapping these results (e.g., the first mapping
step), and comparing these results to results from additional
individuals (e.g., the second mapping step). In addition to
possible other uses, the subject specification explains that the
claimed methods can be used to develop treatments for various
disease conditions.
Appeal Br. 11.
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We do not find this argument persuasive. The claims on appeal do not
require developing treatments for any disease conditions. Rather, as
discussed above, the claims simply require gathering data from different
patients and determining correlations between metabolites bound to different
macromolecules. The claimed method therefore requires nothing more than
gathering data and analyzing it, which is not patent-eligible because it is an
abstract idea.
Appellant also argues that
[s]imilarly to the claims in Rapid Litigation [Rapid Litigation
Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir.
2016)], the claims at issue in the present case do not simply
observe a correlation or merely involve collecting data and
analyzing it against known information. Instead, the pending
claims recite a number of particular process steps (e.g.,
obtaining samples from at least two distinct regions of the body,
measuring these samples to determine a level of metabolite
covalently or coordinately bound to a macromolecule, mapping
these results, and comparing the results to results from
additional individuals). These steps manipulate information
( e.g., metabolite levels in distinct biochemical networks) in a
body to achieve a desired outcome ( the ability to develop a
tailored disease treatment program based on an individual's
metabolite levels).
Appeal Br. 12.
We do not find Appellant's reliance on CellzDirect to be persuasive.
The invention claimed in CellzDirect was an improved method for
producing hepatocytes, which allowed them to be frozen and thawed more
than once. CellzDirect, 827 F.3d at 1045--46. The court held that "the
claims are simply not directed to the ability of hepatocytes to survive
multiple freeze-thaw cycles. Rather, the claims ... are directed to a new and
useful laboratory technique for preserving hepatocytes." Id. at 1048.
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The court distinguished several cases involving "claims ... we have
found patent ineligible in cases since Mayo and Alice." Id. The court found
that, "[ a ]lthough the claims in each of these cases employed method steps,
the end result of the process, the essence of the whole, was a patent-
ineligible concept," whereas the claims at issue in CellzDirect were
"directed to a new and useful method of preserving hepatocyte cells." Id.
We conclude that the claims on appeal are not comparable to those
found eligible for patenting in CellzDirect. Rather, claim 10 recites a
method for determining naturally occurring correlations between levels of
certain metabolites in different individuals, using the known method of
liquid chromatography with electrochemical detection (LCEC). "[S]imply
appending conventional steps, specified at a high level of generality, to laws
of nature, natural phenomena, and abstract ideas cannot make those laws,
phenomena, and ideas patentable." Mayo Collaborative Servs. v.
Prometheus Labs., Inc., 566 U.S. 66, 82 (2012).
Appellant also argues that "even if the pending claims are found to
include some features of judicially recognized exception, ... the pending
claims include additional elements that add significantly more to the
exception." Appeal Br. 12-13. Specifically, Appellant argues that,
prior to the filing of the subject application, it was
unconventional to measure and analyze levels of metabolite
covalently or coordinately bound to a macromolecule in
different parts of the body (e.g., one from a periphery of the
body system/ organ of interest and another from the body
system/organ of interest), as claimed.
Id. at 13. Appellant argues that "the Examiner has failed to cite any teaching
in the prior art that a relationship between levels of metabolite covalently or
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coordinately bound to a macromolecule in body systems/organs of interest
and periphery body systems/organs was known to exist." Id.
As discussed in detail above, claim 10 recites a method of applying
certain laws of nature----correlations between certain metabolite levels in
different individuals-and "any additional steps consist of well-understood,
routine, conventional activity already engaged in by the scientific
community; and those steps, when viewed as a whole, add nothing
significant beyond the sum of their parts taken separately." Mayo, 566 U.S.
at 79--80. Even though the claim requires "collecting information ...
limited to particular content (which does not change its character as
information)," that limitation is still "within the realm of abstract ideas."
Electric Power, 830 F.3d at 1353.
Claims 11 and 13 were not argued separately and therefore fall with
claim 10. 37 C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
We reverse the rejection of claims 10, 11, and 13 under 35 U.S.C.
§ 103(a).
We affirm the rejection of claims 10, 11, and 13 under 35 U.S.C.
§ 101.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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