Ex Parte Bergmann et al

Patent Trials and Appeals Board

Nov 30, 2018

12613891 - (D) (P.T.A.B. Nov. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/613,891 11/06/2009
23599 7590 12/04/2018
MILLEN, WHITE, ZELANO & BRANIGAN, P.C.
2200 CLARENDON BL VD.
SUITE 1400
ARLINGTON, VA 22201
Andreas Bergmann
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.
VOSS-0064 7298
EXAMINER
FOSTER, CHRISTINE E
ART UNIT PAPER NUMBER
1641
NOTIFICATION DATE DELIVERY MODE
12/04/2018 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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docketing@mwzb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDREAS BERGMANN and OLIVER HARTMANN 1
Appeal2017-010601
Application 12/613,891
Technology Center 1600
Before DONALD E. ADAMS, ELIZABETH A. LA VIER, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method for prognosticating an adverse outcome in a
patient suffering from heart failure or shortness of breath. Claims 20-24,
26-30, 32-36, 38--43, 46, and 49-59 are on appeal as rejected under
35 U.S.C. § 101 and§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellant identifies the Real Party in Interest as "B.R.A.H.M.S. GmbH."
Reply Br. 1.
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Application 12/613,891
STATEMENT OF THE CASE
Claim 20 is representative and is reproduced below:
20. A method for prognosticating an adverse outcome in a
patient suffering from heart failure or shortness of breath, who
has not suffered from or is not suffering from myocardial
infarction, comprising:
(a) detecting and quantitating in a blood, serum or plasma sample
obtained from said patient, a level of a first marker which is
mid-regional pro-adrenomedullin (MR-proADM) and a level
of a second marker which is troponin, wherein the detecting
and quantitating of said markers comprise immunoassays in
which the sample is contacted with antibodies that
specifically bind to the respective markers to form detectible
complexes, which are quantified to determine the level of the
markers, and
(b) correlating the level of said markers with said adverse
outcome at a defined time which is within 50 days of
obtaining the sample,
wherein a concentration of MR-proADM between 0.5 to 5.0
nmol/1 in said sample.,_ considered together with the troponin
level, is indicative of said adverse outcome, which indicates a
need for prioritized medical care.
Appeal Br. 21 (Claims Appendix). Claim 24, the other independent claim, is
similar, but differs in requiring the "defined time" to be "within 90 days"
rather than 50 days. Id. at 21-22.
The following rejections are appealed:
Claims 20-24, 26-30, 32-36, 38--43, 46, and 49-59 stand rejected
under 35 U.S.C. § 101 as directed to a judicial exception without
significantly more. Final Action 4.
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Claims 20-24, 26-30, 32-36, 41--43, 46, and 49-59 stand rejected
under 35 U.S.C. § 103(a) over the combined teachings of Gegenhuber, 2
Bergmann, 3 Christ, 4 and Sakhuja. 5 Id. at 7.
Claims 20-24, 26-30, 32-36, 38--43, 46, and 49-59 stand rejected
under 35 U.S.C. § 103(a) over the combined teachings of Gegenhuber,
Bergmann, Christ, Sakhuja, and Peacock. 6 Id. at 12.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prim a facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992)
( emphasis added). Arguments made by Appellants in the Appeal Brief and
properly presented in the Reply Brief have been considered; arguments not
so-presented in the Briefs are waived. See 37 C.F.R. § 4I.37(c)(l)(iv)
(2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010)
2 Alfons Gegenhuber MD et al., Comparative Evaluation of B-Type
Natriuretic Peptide, Mid-Regional Pro-A-type Natriuretic Peptide, Mid-
Regional Pro-Adrenomedullin, and Copeptin to Predict I-Year Mortality in
Patients With Acute Destabilized Heart Failure, 13 J. CARDIAC FAILURE 42-
49 (2007) ("Gegenhuber").
3 US 2007/0212742 Al (published Sept. 13, 2007) ("Bergmann").
4 Michael Christ et al., Multimarker Strategy for Risk Prediction in Patients
Presenting with Acute Dyspnea to the Emergency Department, 126 INT'L J.
CARDIOLOGY 73-78 (2008) ("Christ").
5 Rahul Sakhuja et al., Amino-Terminal Pro-Brain Natriuretic Peptide,
Brain Natriuretic Peptide, and Troponin T for Prediction of Mortality in
Acute Heart Failure, 53(3) CLINICAL CHEMISTRY 412-20 (2007)
("Sakhuja").
6 W. Frank Peacock IV M.D. et al., Cardiac Troponin and Outcome in Acute
Heart Failure, 358(20) N. ENGL. J. MED. 2117-26 (2008) ("Peacock").
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(informative) ("Any bases for asserting error, whether factual or legal, that
are not raised in the principal brief are waived.").
I. PATENT ELIGIBILITY
"Phenomena of nature, though just discovered, mental processes, and
abstract intellectual concepts are not patentable, as they are the basic tools of
scientific and technological work." Mayo Collaborative Servs. v.
Prometheus Labs, Inc., 566 U.S. 66, 71 (2012) (quoting Gottschalkv.
Benson, 409 U.S. 63, 67 (1972)). Claims directed to nothing more than
abstract ideas (such as mathematical algorithms), natural phenomena, and
laws of nature are not eligible for patent protection. Diamond v. Diehr, 450
U.S. 175, 185 (1981); accord MPEP § 2106 (II) (discussing Diehr); see also
Parker v. Flook, 437 U.S. 584, 592-94 (1978) (if, once the mathematical
algorithm is removed from consideration, nothing patentable remains, the
claims are not patent-eligible).
In analyzing patent-eligibility questions under 35 U.S.C. § 101, the
Supreme Court instructs us to "first determine whether the claims at issue
are directed to a patent-ineligible concept." Alice Corp. Pty. Ltd. v. CLS
Bankint'l, 134 S. Ct. 2347, 2355 (2014). If the claims are so directed, we
then move to a second step and "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." Id. (quoting Mayo, 566 U.S. at 78-79).
Here, under Alice's step one, the Examiner determined, "the claims
are directed to a naturally occurring correlation between heart failure or
shortness of breath outcome or risk and levels of biomarkers." Final Action
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4. Further, the Examiner found "the correlation of biomarker levels,
considered individually or in a combination, to risk or presence of disease or
survival occurs naturally in the human body without any outside human
action." Id. at 5.
Under Alice's step two, the Examiner determined that:
The combination of steps recited in these process claims taken as
a whole, including the well-understood, routine, and con-
ventional steps of data acquisition recited with a high level of
generality which would substantially foreclose others from using
the naturally occurring correlation, or limitations of the use to a
particular technological environment (field-of-use) ("Guidance",
LB. I), such as to a generic immunoassay, are not sufficient to
qualify as a patent-eligible practical application of a law of nature
or of a naturally occurring correlation, i.e. of a natural principle,
as the claims do not amount to significantly more than a
statement of the natural principle, i.e. the correlation, with
generalized directions to apply it to the relevant population.
Id. at 4--5. As evidence that the additionally claimed subject matter (beyond
the elements directed to the natural phenomenon) do not go beyond routine
and conventional activity the Examiner cited Bergmann, Ng, 7 and Khan. 8
Id. at 14--15; Answer 16.
It is without question that "[t]he line between a patentable 'process'
and an unpatentable 'principle' is not always clear." Flook, 437 U.S. at 589;
see also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1150
(Fed. Cir. 2016) ("defining the precise abstract idea of patent claims in many
7 US 2008/0213746 Al (published Sept. 4, 2008) ("Ng").
8 De Sohail Q. Khan et al., Prognostic Value of Midregional Pro-
Adrenomedullin in Patients With Acute Myocardial Infarction, 49(14) J. AM.
COL. CARDIOLOGY 1524--32 (2007) ("Khan").
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cases is far from a 'straightforward' exercise") (quoting DDR Holdings, LLC
v. Hotels.com, L.P., 773 F.3d 1245, 1257 (Fed. Cir. 2014)). Here, a
reasonable case could be made that the Examiner's determination under
Alice 's step one is without error on the basis that the claims are directed to a
natural correlation between the body's expression of certain proteins and the
mortality risk associated with a cardiac failure. See, e.g., Mayo, 566 U.S.
66; Genetic Technologies, Ltd. v. Merial L.L.C., 818 F.3d 1369 (Fed. Cir.
2016); Ariosa Diagnostics, Inc. v. Seqenom, Inc., 788 F.3d 1371 (Fed. Cir.
2015); and In re BRCAJ- & BRCA2-Based Hereditary Cancer Test Patent
Litigation, 774 F.3d 755 (Fed. Cir. 2014). As noted by the Supreme Court,
however, "all inventions at some level embody, use, reflect, rest upon, or
apply laws of nature, natural phenomena, or abstract ideas" and "a process is
not unpatentable simply because it contains a law of nature or a
mathematical algorithm." Mayo, 566 U.S. at 71 (quoting Diehr, 450 U.S. at
187).
Regarding the Alice step one determination, Appellants argue that "the
definition for the naturally occurring phenomenon is too broad." Appeal Br.
5. Appellants also argue that "[t]he claimed invention only makes use of the
naturally occurring phenomenon of the correlation between heart failure or
shortness of breath outcome or risk and MR-proADM level when such
phenomenon is also used together with the correlation between heart failure
of shortness of breath outcome or risk and troponin level." Id.
These arguments are not persuasive. The Examiner's identified
natural phenomenon appears on target and pairing two natural phenomena or
natural occurring things, here (1) MR-proADM as a natural marker for
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cardiac distress and (2) troponin as another natural marker for cardiac
distress, does not mean the new package is transformed into a patent-eligible
invention. See Funk Bros. Seed Co. v. Kala Inoculant Co., 333 U.S. 127,
129-32 (1948) ("The aggregation of select strains of the several [bacterial]
species" does not change the fact that their "qualities are the work of nature"
and "[t]hose qualities are of course not patentable.").
Regarding the Alice step two determination, Appellants argue:
Appellants further urge that the USPTO, in considering
whether the elements of the invention, other than the alleged
natural principles, define "significantly more" than the natural
principles, is failing to consider whether the elements of the
invention taken in combination are "well-understood, routine,
conventional" activities in the relevant art. Appellants submit
that the Final Office action is merely considering whether such
elements are individually known or conventional (as evidenced
by the citation of multiple references to evidence there
knowledge) rather than whether their combination was known or
conventional.
Appeal Br. 6-7. Appellants contend:
Even if it was conventional to assess MR-proADM level and
troponin levels separately, it certainly was not conventional to
conduct a method which includes detecting and quantifying both
the MR-proADM level and troponin level in combination or
provide a prognosis on adverse outcome or risk stratification
therefrom. There is no evidence on the record to suggest that
assessing and considering both of these levels together was
conventional - or even remotely known.
Id. at 7. Appellants argue that "[s]omething that is 'conventional' is not
merely just known but well known and commonly in use," and that the
combination of claimed steps (i.e., detecting and quantifying both MR-
proADM and troponin) was not conventional under such a definition. Id. at
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7-8. Appellants contend the relevant disclosure of Ng is generic and is not
directed to measuring MR-proADM and troponin in combination; no
teaching such was conventional. Reply Br. 1-2.
Even if the claims on appeal are "directed to" a natural phenomenon
under the first step of the Alice framework as determined by the Examiner,
we conclude that the Examiner has not established that the additional
elements recited in the claims, considered individually and as an ordered
combination, were well-understood, routine, and conventional. Regarding a
determination that, e.g., non-natural-phenomenon, claim elements are
merely routine and conventional, the Federal Circuit has explained that,
Whether something is well-understood, routine, and con-
ventional to a skilled artisan at the time of the patent is a factual
determination. Whether a particular technology is well-
understood, routine, and conventional goes beyond what was
simply known in the prior art. The mere fact that something is
disclosed in a piece of prior art, for example, does not mean it
was well-understood, routine, and conventional.
Berkheimer v. HP Inc., 881 F.3d 1360, 1369 (Fed. Cir. 2018).
Here, after we strip away the natural phenomenon ( expression of
elevated levels of MR-proADM and troponin in patients suffering from heart
failure and that they correlate to subsequent adverse outcomes), we are left
with the claims' required coordinated steps of detecting MR-proADM and
troponin using immunoassays (respective antibodies), making a correlation
of adverse outcome within 50 days ( or 90 days in the case of claim 24) of
sampling, where a concentration of 0.5-5.0 nmol/L MR-pro-ADM and some
unidentified troponin level indicates a need for prioritized medical care. The
Examiner concluded that the references Bergmann, Ng, and Khan evidenced
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that such additional steps beyond the natural correlation of such proteins to
predictable adverse cardiac events was no more than routine ( and
conventional). Final Action 4---6, 14--15; Answer 12-19.
Although we agree with the Examiner that these cited prior art
references may disclose, individually or even in some combination,
detecting and measuring MR-proADM and/or troponin, using
immunoassays, and correlating such measurements with the likelihood of
adverse cardiac events, we conclude that these references do not indicate
that the claimed individual steps, much less the ordered combination thereof,
were necessarily routine and/or conventional in the art. To the contrary, the
cited references describe the relevant techniques individually as inventive or
experimental.
For example, Bergmann discloses that its invention is determining
MR-proADM levels, along with other markers, using antibodies, to diagnose
cardiac and other conditions; not that detecting MR-proADM using
immunoassay was necessarily routine or conventional. Bergmann Abstract,
,r,r 1-15 (background), ,r,r 48--49. Further, Ng discloses that its invention is
diagnosing cardiac failure risk by measuring MR-proADM and troponin,
and even that, prior its invention, measuring proADM to diagnose sepsis and
also multi-marker strategies detecting ADM (and BNP) were known to be
predictive of heart failure; but this is not necessarily evidence that the
claimed steps, individually or as an ordered combination were routine or
conventional. Ng Abstract, ,r,r 3-8 (background), 32-34. Moreover, Khan
discloses a study that confirmed the prognostic value of measuring MR-
proADM for heart failure/death and also that troponin levels were elevated
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in the relevant patient population; however, this does not mean that such
measurements and identified correlations were routinely or customarily
made or used. Khan 1525-27. While these prior art teachings may be
relevant in analyzing anticipation or obviousness where routineness and
conventionality are irrelevant, they do not establish the routineness or
conventionality of the claimed subject matter when analyzing patent
eligibility. See Diehr, 450 U.S. at 189-90 (novelty and patent eligibility are
wholly separate considerations); Classen Immunotherapies, Inc. v. Biogen
IDEC, 659 F.3d 1057, 1064---65 (Fed. Cir. 2011) (quoting Diehr: "rejection
on either of [ § 102 or 103] does not affect the determination that
respondents' claims recited subject matter which was eligible for patent
protection under § 101 "); see also MySpace, Inc. v. Graph On Corp., 672
F.3d 1250, 1261 (Fed. Cir. 2012) ("Following the Supreme Court's lead,
[we] should avoid reaching for interpretations of broad provisions, such as
§ 101, when more specific statutes, such as § § 102, 103, and 112, can decide
the case.").
Thus, while the claim is directed to a natural phenomenon and the
prior art might teach or suggest the individual steps recited by the appealed
claims, or components thereof, the evidence on appeal does not support the
conclusion that the claimed steps, as an ordered combination, constitute
mere routine and customary techniques that do not provide the "something
more" than the natural phenomenon upon which they rely so as to provide an
inventive concept.
For these reasons, we find the rejection insufficiently supported on the
record before us. We reverse the rejection.
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IL OBVIOUSNESS
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). "[W]hen a patent
claims a structure [ or method] already known in the prior art that is altered
by the mere substitution of one element [ or step] for another known in the
field, the combination must do more than yield a predictable result." Id.
(citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). "In determining
whether the subject matter of a patent claim is obvious, neither the particular
motivation nor the avowed purpose of the patentee controls. What matters is
the objective reach of the claim. If the claim extends to what is obvious, it is
invalid under § 103." Id. at 419.
[M]otivation to combine is ... inextricably linked to the level of
ordinary skill. . . . If the level of skill is low, ... then it may be
rational to assume that such an artisan would not think to
combine references absent explicit direction in a prior art
reference. If, however, ... the level of skill is ... [high, as it is
here], then one can assume comfortably that such an artisan will
draw ideas from chemistry and systems engineering-without
being told to do so.
DyStar Textilfarben GmbH & Co. v. C.H. Patrick Co., 464 F.3d 1356, 1370
(Fed. Cir. 2006). "[T]he question is whether there is something in the prior
art as a whole to suggest the desirability, and thus the obviousness, of
making the combination, not whether there is something in the prior art as a
whole to suggest that the combination is the most desirable combination
available." In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (citation
omitted).
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It is obvious to those skilled in the art to substitute one known
equivalent for another. See In re Omeprazole Patent Litigation, 483 F.3d
1364, 1374 (Fed. Cir. 2007) ("[T]his court finds no ... error in [the]
conclusion that it would have been obvious to one skilled in the art to
substitute one ARC [alkaline reactive compound] for another."). "[I]f a
technique has been used to improve one device, and a person of ordinary
skill in the art would recognize that it would improve similar devices in the
same way, using the technique is obvious unless its actual application is
beyond his or her skill." KSR, 550 U.S. at 417. "[F]amiliar items may have
obvious uses beyond their primary purposes, and in many cases a person of
ordinary skill will be able to fit the teachings of multiple patents together
like pieces of a puzzle." Id. at 420.
One way for a patent applicant to rebut a prima facie case of
obviousness is to make a showing of "unexpected results," i.e.,
to show that the claimed invention exhibits some superior
property or advantage that a person of ordinary skill in the
relevant art would have found surprising or unexpected.
In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). However, "[m]ere recognition
of latent properties in the prior art does not render nonobvious an otherwise
known invention." In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.
Cir. 1991). "To be particularly probative, evidence of unexpected results
must establish that there is a difference between the results obtained and
those of the closest prior art, and that the difference would not have been
expected by one of ordinary skill in the art at the time of the invention."
Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977
(Fed. Cir. 2014). "The evidence presented to rebut aprimafacie case of
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obviousness must be commensurate in scope with the claims to which it
pertains." In re Dill, 604 F.2d 1356, 1361 (CCPA 1979).
Findings of Fact
We adopt the Examiner's findings of fact and rationale on
obviousness as set forth in the Final Action and Answer. The following
findings of fact highlight certain evidence.
FF 1. Gegenhuber disclosed that each of B-type natriuretic
peptide (BNP), mid-regional pro-A-type natriuretic peptide (MR-
proANP), mid-regional pro-adrenomedullin (MR-proADM), and the
C-terminal part of the arginine vasopressin prohormone (Copeptin),
can each be measured in cardiac patients and that increases in each
and any of these markers is strongly predictive of mortality.
Gegenhuber 42 (abstract).
FF2. Gegenhuber disclosed that MR-proADM can be detected
and measured via ( commercially available) immunoassay to predict
heart failure. Gegenhuber 43.
FF3. Gegenhuber disclosed that MR-proADM measurements
between 0.65-1.21 nmol/L were predictive of survival in cardiac
patients and MR-proADM measurements of 0.95-2.43 nmol/L were
predictive of death in cardiac patients (with a p-value of< 0.001 ).
Gegenhuber 44 (Table 1 ).
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FF4. Gegenhuber disclosed data in the following graph:
;..,....,,....~ --~-----.... -.,.._-., ..... ...,.
• . . . Cw-.--.~·l-..
ft'ig. 4. Kaplan-Meier plots showing sitrvival in 137 patients
\.Vith acute destabilized hean failure \vho were stratified into 3
groups ac,:ording to plasma mid-regional prt)-adrennmedul.lfa
terciles at base.Hoe (ht terdk <0.75 nmolfL. n = 4 1 .23 mnol/L, n = 46, dotted line; log-rank test for
trend, P < .001),
The graph reproduced above shows patient mortality as correlated
with elevated levels ofMR-proADM over the course of one year and
shows a particularly precarious drop in mortality over the first 50 ( or
fewer) days for patients having greater than 1.23 nmol/L measured
MR-proADM. Gegenhuber 46 (Fig. 4).
FF5. Gegenhuber states, "most single-variable markers are
characterized by unsatisfactory discrimination of patients with and
without increased heart failure mortality," and suggests that more than
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a single predictive marker should be considered simultaneously, as a
multivariable analysis, for best results. Gegenhuber 45--48 (Table 5).
FF6. Bergmann disclosed measuring mid-proAM (MR-
proADM) by immunoassay to diagnose cardiac issues, among other
conditions. Bergmann Abstract.
FF7. Bergmann disclosed that measured concentrations of
MR-proADM between 0.5-3.0 (or slightly higher) nmol/L were
indicative of cardiac disease and that MR-proADM "gives highly
significant measured results" as to cardiac diagnosis. Bergmann Fig.
2, ,r 48.
FF8. Bergmann teaches and suggests that, in addition to
measuring MR-proADM, a cardiac diagnosis should also
simultaneously measure ANP, BNP, proANP, and/or proBNP (and
also CRP). Bergmann ,r 49.
FF9. Christ disclosed a multimarker approach that improved
the prediction of risk of death in patients that assessed BNP, cardiac
troponin, and CRP, indicating that a predictive threshold for the
troponin component was> 0.8 µg/L, and further stating that "risk of
death or rehospitalization significantly increased with the number of
elevated biomarkers," concluding that a "multimarker approach with
simultaneous assessment of BNP, and cTNI [troponin] demonstrate[d]
potential to assist clinicians in predicting risk." Christ 73 (abstract).
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FFlO. Christ disclosed data in the following graphs:
A) Mortality at 30 days
B) Mortality at 24 months
0.6 P<0.001
0.5·
~ 0.4 -! 0.3·
0
:! 0.2
0.1 ·
~ l
0 '
0 1 2 3
No. of elevated biomarker$
flg J •. \forhtl!!y a~b aJt;;.~r JO days {A) and 24 rn.onths {B) nf follnw-np in
Yl5 pi:11it\:cK~ pn~.srming ,1.,'J;_h ~,:)Jk dytp;.K:a to foi.; r..un~rg