Ex Parte Penn et al

Patent Trial and Appeal Board

Dec 8, 2016

13825379 (P.T.A.B. Dec. 8, 2016)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/825,379 03/21/2013 Marc S. Penn CCF-018733 US PCT 9198
26294 7590 12/12/2016
TAROLLI, SUNDHEIM, COVELL & TUMMINO L.L.P.
1300 EAST NINTH STREET, SUITE 1700
CLEVELAND, OH 44114
EXAMINER
CHEU, CHANGHWA J
ART UNIT PAPER NUMBER
1678
NOTIFICATION DATE DELIVERY MODE
12/12/2016 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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
rkline @ tarolli. com
docketing@tarolli.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARC S. PENN and EDWARD J. LESNEFSKY
Appeal 2015-006953
Application 13/825,379
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a method
for predicting myocardial damage in a subject having or at risk of cardiac
disease. The Examiner rejected the claims as directed to non-statutory
subject matter. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
“Plasma levels of high-density lipoproteins (HDL) and apolipoprotein
AI (ApoAI) are inversely associated with cardiovascular morbidity and
mortality” (Spec. 13). “An aspect of the application relates to a method for
predicting myocardial damage in a subject having or at risk of cardiac
1 Appellants identify the Real Party in Interest as The Cleveland
Clinic Foundation (see App. Br. 3).
Appeal 2015-006953
Application 13/825,379
disease. The method includes determining a level of apolipoprotein AI
(ApoAI) and a level of CoQlO in the subject” (Spec. 16).
The Claims
Claims 1, 6—9, 14—17, and 22—24 are on appeal. Claim 1 is
representative and reads as follows:
1. A method for predicting myocardial damage in a subject
having or at risk of cardiac disease, the method comprising:
obtaining one or more plasma samples from the subject,
the one or more plasma samples including CoQio and ApoAI;
determining a level of apolipoprotein AI (ApoAI) in the
subject;
determining a level of Coenzyme Qio (CoQio) in the
subject, wherein the level of ApoAI and CoQio in the subject is
determined using an ELISA assay and/or high-performance
liquid chromatography; and
comparing the determined levels of ApoAI and CoQio to
control levels, wherein a decreased level of ApoAI and a
decreased level of CoQio compared to control levels are
indicative of the subject having an increased risk of greater
myocardial damage following a myocardial infarction.
The Issue
The Examiner rejected claims 1, 6—9, 14—17, and 22—24 under 35
U.S.C. § 101 as directed towards non-statutory subject matter (Ans. 3—5).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the claims are directed towards non-
statutory subject matter?
Findings of Fact
1. The Specification teaches “[ajfter obtaining the biological
sample from the subject, the levels of the cardiac markers (e.g., ApoAI and
Appeal 2015-006953
Application 13/825,379
CoQlO) are determined using any one or combination of known biochemical
assays or techniques” (Spec. 135; emphasis added).
2. The Specification teaches that known techniques include
“antibody based assays, such as ELISA and Western blots, mass
spectroscopy (MS) (e.g., LC/ES1/MS/MS), fluorometric assays and
chromatography (e.g., HPLC, affinity column, etc.)” (Spec 1 35).
3. The Specification cites to Tang et al., HPLC Analysis of
Reduced and Oxidized Coenzyme Qw in Human Plasma, 47 Clinical
Chemistry 256—265 (2001), demonstrating that HPLC analysis of CoQio was
known as of 2001 (Spec. 136).
4. The Specification teaches that “[cjontrol levels of ApoAI polypeptides
and CoQio in biological samples, for example, can be obtained (e.g., mean
levels, median levels, or ‘cut-off levels) by assaying a large sample of
subjects in the general population ... as described in Knapp, R.G. and
Miller, M.C. (1992): Clinical Epidemiology and Biostatistics” (Spec. 140).
Principles of Law
In Mayo Collaborative Services v. Prometheus
Laboratories, Inc., . . . 132 S.Ct. 1289 . . . (2012), the Supreme
Court set forth a framework for distinguishing patents that
claim laws of nature, natural phenomena, and abstract ideas
from those that claim patent-eligible applications of those
concepts. First, we determine whether the claims at issue are
directed to a patent-ineligible concept. Id. at 1297. If the answer
is yes, then we next consider the elements of each claim both
individually and “as an ordered combination” to determine
whether additional elements “transform the nature of the claim”
into a patent-eligible application. Id. at 1298. The Supreme
Court has described the second step of this analysis as a search
for an “inventive concept”—i.e., an element or combination of
elements that is “sufficient to ensure that the patent in practice
Appeal 2015-006953
Application 13/825,379
amounts to significantly more than a patent upon the [ineligible
concept] itself.” Id. at 1294.
Ariosa Diagnostics v. Sequenom, Inc. 788 F.3d 1371, 1375 (Fed. Cir. 2015).
Analysis
We follow the analytical framework set forth by the Supreme Court in
Mayo and applied by our reviewing court in Ariosa. Under this rubric, we
agree with the Examiner that claim 1 sets forth a patent-ineligible law of
nature, specifically, the relationship between CoQio and ApoAI levels as
measured by ELISA and/or HPLC and the likelihood that a patient is at risk
for cardiac disease (see Ans. 4).
Consistent with Mayo, “[i]f a law of nature is not patentable, then
neither is a process reciting a law of nature, unless that process has
additional features that provide practical assurance that the process is more
than a drafting effort designed to monopolize the law of nature itself.” Mayo
at 1297. In this case, none of the steps in claim 1 represent more than
drafting effort. The Specification acknowledges that monitoring levels of
ApoAI and CoQio by HPLC or ELISA are known (FF 1—2) and specifically
identifies prior art assays for performing HPLC measurement of CoQio (FF
3) and determining control levels (FF 4). We therefore agree with the
Examiner that there is no principled distinction between the instant claim 1
and the claim at issue in Mayo.
Appellants contend that
claims 1, 6-9, 14-17, and 22-24 apply a law of nature to a
new and useful end and do not attempt to merely claim the
law itself. The present application is based upon the
discovery of the law of nature that specific biomarkers are
decreased in the plasma of patients with an increased risk of
Appeal 2015-006953
Application 13/825,379
greater myocardial damage following a myocardial
infarction and that the amounts or levels of these markers
can be used to predict and/or determine myocardial damage
in a subject having or at risk of cardiac disease.
(App. Br. 9; cf. App. Br. 10).
We do not find these arguments persuasive because, as in Mayo, the
“‘wherein’ clauses simply tell a doctor about the relevant natural laws, at
most adding a suggestion that he should take those laws into account when
treating his patient. That is to say, these clauses tell the relevant audience
about the laws while trusting them to use those laws appropriately.” Mayo,
132 S.Ct. at 1297. There is no reasonable doubt that the law of nature in
Mayo was also being applied for a new and useful end, optimizing 6-
thioguanine therapeutic efficacy, but the Supreme Court found that this
application was insufficient for patentable utility because the claim “steps
are not sufficient to transform unpatentable natural correlations into
patentable applications of those regularities.” Id. at 1298. The steps of the
instant claim are demonstrably routine, conventional activity (FF 1—4) and
“add nothing significant beyond the sum of their parts taken separately.” Id.
Appellants contend that
In contrast to the claims in Mayo, claims 1, 6-9, 14-17, and 22-
24 include additional steps or a combination of steps that
integrate a law of nature into the claimed invention such that
that the law of nature is practically applied and the steps include
activity that goes beyond what was well-understood, routine or
conventional activity for researchers in the field. . . .
The recited steps of claims 1, 6-9, 14-17, and 22-24 are not
directed to routine, well-understood, or conventional activity
previously engaged by researchers in the field. Prior to the
Appeal 2015-006953
Application 13/825,379
present application, researchers did not routinely determine the
risk of greater myocardial damage in a subject having or at risk
of cardiac disease using the determined levels of ApoAl or
HDL and CoQlO in a bodily sample obtained from plasma of a
subject.
(App. Br. 12; cf. Reply Br. 3).
We find this argument unpersuasive because, as the Specification
acknowledges, the ELISA and HPLC techniques for measuring ApoAl and
CoQ io levels were known in the prior art (FF 1—3) as was the use of controls
(FF 4). That these known prior art processes were not previously applied to
determining risk of cardiac disease does not distinguish the claims because
“appending routine, conventional steps to a natural phenomenon, specified at
a high level of generality, is not enough to supply an inventive concept.”
Ariosa, 788 F.3d at 1378.
Appellants contend that “others are not foreclosed, for example, from
determining a level of ApoAl or HDL and CoQio in a sample that is not
plasma (e.g., another tissue type) using different assays” (App. Br. 14; cf
Reply Br. 4).
We do not find this argument persuasive because “the absence of
complete preemption does not demonstrate patent eligibility. In this case,
[patentees] attempt to limit the breadth of the claims by showing alternative
uses of [the invention] outside of the scope of the claims does not change the
conclusion that the claims are directed to patent ineligible subject matter.
Where a patent’s claims are deemed only to disclose patent ineligible subject
matter under the Mayo framework, as they are in this case, preemption
concerns are fully addressed and made moot.” Ariosa, 788 F.3d at 1379.
Appeal 2015-006953
Application 13/825,379
Thus, even though the claims are limited to the use of two particular known
assays, ELISA and HPLC, for analysis of the levels of ApoAI and C0Q10,
and do not fully preempt the natural relationship, Ariosa explains that the
claims remain ineligible because they are drawn to patent ineligible subject
matter. Id.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
claims are directed towards non-statutory subject matter.
SUMMARY
In summary, we affirm the rejection of claims 1, 6—9, 14—17, and 22—
24 under 35 U.S.C. § 101 as directed towards non-statutory subject matter.
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