Ex Parte Manolescu et al

Patent Trial and Appeal Board

Nov 16, 2016

13451210 (P.T.A.B. Nov. 16, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/451,210 04/19/2012
4743 7590 11/18/2016
MARSHALL, GERSTEIN & BORUN LLP
233 SOUTH WACKER DRIVE
6300 WILLIS TOWER
CHICAGO, IL 60606-6357
FIRST NAMED INVENTOR
Andrei Manolescu
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.
30847/44317A 4204
EXAMINER
HANEY, AMANDA MARIE
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
11/18/2016 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):
mgbdocket@marshallip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDREI MANOLESCU,
ANNA HELGADOTTIR, and
GUDMAR THORLEIFSSON1
Appeal2014-000655
Application 13/451,210
Technology Center 1600
Before ULRIKE W. JENKS, ROBERT A. POLLOCK, and
TA WEN CHANG, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 1-20 and 22-31. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as assignee deCODE genetics
ehf, located in Reykjavik Iceland. Appellants further state that deCODE is a
subsidiary of Amgen, Inc. App. Br. 3.
Appeal2014-000655
Application 13/451,210
STATEMENT OF THE CASE
Appellants' invention relates to "methods of diagnosing susceptibility
to cardiovascular disease, including coronary artery disease, MI
[ (myocardial infarction)], abdominal aorta aneurysm, intracranial aneurysm
restenosis and peripheral arterial disease, by assessing the presence or
absence of alleles of certain polymorphic markers found to be associated
with cardiovascular disease." Spec. Abstract.
Claims 1, 22, and 27 are independent. Claim 1 is illustrative
(additional paragraphing added):
1. A method for determining a susceptibility to arterial
disease in a human individual, comprising
determining the presence or absence of allele G of
polymorphic marker rs10757278 in a nucleic acid sample
from the individual, and
determining an increased susceptibility to arterial
disease for the human individual from the presence of the G
allele of rs10757278 in the nucleic acid sample, or
determining a decreased susceptibility to arterial
disease from the absence of the G allele of rs10757278 in the
nucleic acid sample.
Claims 1-20 and 22-31 stand rejected for obviousness-type double
patenting in view of claims 1, 4--8, 10-11, 23, 34--37, 47-51, 66, 75, 83 of
copending application No. 12/302,538 and, with respect to claim 31, further
in view Stephan. 2 Final Rejection ("Fin. Rej.") dated Jan. 29, 2013, 13-18;
Advisory Action dated April 23, 2013, 2; Examiner's Answer ("Ans.") dated
Aug. 14, 2013, 12.
2 Stephan et al. US 2008/0131887 (Al), published June 5, 2008.
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Claims 1-20 and 22-31 stand rejected as drawn to non-patentable
subject matter under 35 U.S.C. § 101.
ANALYSIS
Obviousness-type Double Patenting
Appellants decline to address the merits of the Examiner's rejections
of claims 1-20 and 22-31 for obviousness-type double patenting. See App.
Br. 12. We summarily affirm the rejection. See MPEP § 1205.02 ("If a
ground of rejection stated by the examiner is not addressed in the appellant's
brief, appellant has waived any challenge to that ground of rejection and the
Board may summarily sustain it."); Ex parte Frye, 94 USPQ2d 1072, 1075
(BP AI 2010) (precedential) ("If an appellant fails to present arguments on a
particular issue - or, more broadly, on a particular rejection - the Board will
not, as a general matter, unilaterally review those uncontested aspects of the
rejection.").
35 U.S.C. § 101
We have considered Appellants' contentions that the Examiner erred
in rejecting claims 1-20 and 22-31 as drawn to unpatentable subject matter.
App. Br. 12-50; Reply Br. 3-24; see Transcript of Oral Hearing dated Oct.
4, 2016. We disagree with Appellants' contentions and adopt as our own the
Examiner's factual findings and legal conclusions. Fin. Rej. 2-13; Advisory
Action 2; Ans. 2-15. We provide the following additional comments for
clarity and emphasis.
Section 101 of the Patent Statute broadly provides that, "[ w ]hoever
invents or discovers any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof, may
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obtain a patent therefor, subject to the conditions and requirements of this
title." Supreme Court precedents, however, provide three specific
exceptions to the broad categories of§ 101: laws of nature, natural
phenomena, and abstract ideas. Bilski v. Kappas, 561 U.S. at 625. "The
'abstract ideas' category embodies the longstanding rule that '[a]n idea of
itself is not patentable."' Alice Corp. Pty. Ltd. v. CLS Bank Int 'l, 134 S. Ct.
2347, 2355 (2014) (citing Gottschalkv. Benson, 409 U.S. 63, 67 (1972)).
In Alice, the Supreme Court referred to the two-step analysis set forth in
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289
(2012), as providing "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." Alice, 134 S. Ct. at 2355
(citing Mayo, 132 S. Ct. at 1289). Under Mayo, "[w]e must first determine
whether the claims at issue are directed to a patent-ineligible concept." Id.
Next, "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." Id.
(citing Mayo, 132 S. Ct. at 1297-98).
To be patentable under Mayo, a claim must do more than simply state
the law of nature or abstract idea and add the words "'apply it."' Mayo, 132
S. Ct. at 1294; Benson, 409 U.S. at 67. Likewise, "[s]imply appending
conventional steps, specified at a high level of generality," is not "enough"
for patent eligibility. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at
1300). Moreover, "[ w ]hile preemption may signal patent ineligible subject
matter, the absence of complete preemption does not demonstrate patent
eligibility .... Where a patent's claims are deemed only to disclose patent
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ineligible subject matter under the Mayo framework, as they are in this
case, preemption concerns are fully addressed and made moot." Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015),
cert. denied, No. 15-1182, 2016 WL 1117246 (U.S. June 27, 2016); see also
Vehicle Intelligence & Safety LLC v. Mercedes-Benz USA, LLC, 635 F.
App'x 914, 918 (Fed. Cir. 2015), cert. denied, No. 15-1201, 2016 WL
1171121 (U.S. May 31, 2016) ("And while assessing the preemptive effect
of a claim helps to inform the Mayo/Alice two-step analysis, the mere
existence of a non-preempted use of an abstract idea does not prove that a
claim is drawn to patent-eligible subject matter.").
To summarize the Examiner's position, the claims on appeal are
"drawn to methods for determining/diagnosing/assessing susceptibility to
arterial disease," which require determining the presence of a polymorphic
marker (the G allele of rs10757278) and correlating the presence or absence
of this marker with susceptibility to arterial disease. See Fin. Rej. 3.
According to the Examiner, this correlation between the G allele of
rs10757278 and susceptibility to arterial disease is a law of nature. Id. In
accord with step 2 of the Alice/ Mayo framework, the Examiner further
determined that any additional claim steps "consist of well-understood,
routine, conventional activity already engaged in by the scientific
community" which, "when viewed as a whole, add nothing significant
beyond the sum of their parts taken separately." Id.
Appellants contend, inter alia, that the Examiner's rejection is
improper because "even if ... the present invention involves a 'law of
nature,' the claims are not directed to the law of nature per se, but to a
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practical application of it." App. Br. 13 (emphases removed). We do not
find Appellants' argument persuasive.
The appealed claims are generally drawn to determining an increased
(or decreased) susceptibility to arterial disease based on the presence (or
absence) of a particular polymorphic allele. This is precisely on point with
the claims found unpatentable in Mayo, which "set forth laws of nature-
namely, relationships between concentrations of certain metabolites in the
blood and the likelihood that a dosage of a thiopurine drug will prove
ineffective or cause harm." Mayo, 132 S. Ct. at 1296. The claims before us
similarly inform the relevant audience of certain laws of nature:
specifically, the relationship between the G allele of rs10757278 in an
individual's genome and susceptibility to heart disease. See also Genetic
Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1379--80 (Fed. Cir. 2016), cert.
denied, (U.S. Oct. 3, 2016) (finding claims unpatentable under§ 101 where,
"the novelty of looking to non-coding DNA to detect a coding region allele
of interest resides in the novelty of the newly discovered natural law of
linkage disequilibrium between coding and non-coding regions and adds
little more than a restatement of the natural law itself').
Appellants appear to contend that, unlike the claims at issue in Mayo,
the claims before us recite the practical application of advising individuals of
their risk of heart disease. See e.g., App. Br. 21 ("The claimed invention
informs a subject about the subject's susceptibility to arterial disease, not
about a law of nature."); id. at 27 ("[T]he claims constitute a practical
application: a prognostic test for a human individual that identifies the
presence or absence of a heightened risk of disease."); Tr. 7: 6-8: 10
("Advising a risk is a practical application.").
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None of the claims before us, with the possible exception of claim 7,
discussed below, recites a step of advising individuals of their risk of heart
disease. McRO and CellzDirect, raised by Appellants at oral argument are,
therefore, inapposite at least with respect to those claims. See Tr. 3:10-14,
5:2----6:7 (referencing McRO, Inc. v. Bandai Namco Games Am. Inc., No.
2015-1080, 2016 WL 4896481 (Fed. Cir. Sept. 13, 2016); Rapid Litig.
Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016)).
In contrast to the claims on appeal, those at issue in McRO expressly
recite an application step, namely, "applying said final stream of output
morph weight sets to a sequence of animated characters to produce lip
synchronization and facial expression control of said animated characters."
WL 4896481 at *3. The court determined that McRO's claims are not
directed to an unpatentable abstract idea, but instead are directed to "a
specific asserted improvement in computer animation." Id. at 8. In
particular, the court explained that claimed process as a whole, "renders
information into a specific format that is then used and applied to create
desired results: a sequence of synchronized, animated characters." Id. at 9.
The representative claim in Cellzdirect also recites an express
application step, in this case involving, "cryopreserving []recovered viable
hepatocytes." 827 F.3d at 1046. The court found the claim "patent eligible
because it applies the discovery that hepatocytes can be twice frozen to
achieve a new and useful preservation process." Id. at 1050-1051. The
claims before us, however, merely inform the relevant audience of the
existence of a correlation between one allele of a polymorphic locus and
susceptibility to arterial disease, without reciting a practical application of
that relationship.
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We further note that dependent claim 7 recites the step of
"communicating the susceptibility to at least one entity selected from the
group consisting of the individual, a genetic counselor, a physician, and a
healthcare worker." Merely presenting the results of a process otherwise
unpatentable under section 101 is, however, insufficient to establish
eligibility under the statute. See Fair Warning IP, LLC v. Iatric Sys., Inc.,
No. 2015-1985, 2016 WL 5899185, at *3 (Fed. Cir. Oct. 11, 2016) (claim
unpatentable under§ 101 despite recitation of the step: "providing
notification if [an] event has occurred").
To the extent that a step of advising individuals of their risk of heart
disease may be somehow implicit in the claims on appeal, they would not
differ substantially from those found invalid in Mayo. The claims at issue in
Mayo include a step of determining the level of a 6-thioguanine metabolite
in a patient, and "wherein" clauses indicating a need to increase (or
decrease) the amount of parent drug subsequently administered when the
patient's 6-thioguanine levels were less than (or greater than) specified
limits. Mayo, 132 S. Ct. at 1295 (e.g., a "level of 6-thioguanine less than
about 230 pmol per 8xl08 red blood cells indicates a need to increase the
amount of said drug subsequently administered to said subject"). The
"wherein" clauses thus describe metabolite concentrations above which
there is a likelihood of harmful side-effects and below which it is likely that
the drug dosage is ineffective, thereby informing doctors that metabolite
concentrations above or below these thresholds "indicate a need" to adjust
the drug dosage. See id. at 1295. The Court explained that these limitations
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
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clauses tell the relevant audience about the laws while
trusting them to use those laws appropriately where they are
relevant to their decisionmaking (rather like Einstein telling
linear accelerator operators about his basic law and then
trusting them to use it where relevant).
Id. at 1297.
Thus, once the relationship between safe and effective dosing of the
parent drug and threshold levels of the 6-thioguanine metabolite was known,
the claims at issue in Mayo implicitly direct a health care provider to
increase (or decrease) the amount of drug administered when metabolite
levels are below (or above) certain thresholds. See also Genetic Techs., 818
F.3d at 1379 (claim step of "analyzing the amplified DNA sequence to
detect the allele" "merely informs the relevant audience---e.g., doctors or
others seeking to make a genetic diagnosis-to apply a law of nature for a
purpose---detecting a polymorphism within a coding region of an allele of
interest). Accordingly, to the extent the claims on appeal may be read to
implicitly include the step of advising patients of their risk of heart disease,
we remain constrained to find them unpatentable for the same reasons as
those at issue in Mayo.
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SUMMARY
I. We summarily affirm the rejection of claims 1-20 and 22-31 for
obviousness-type double patenting.
II. We affirm the rejection of claims 1-20 and 22-31 under 35 U.S.C.
§ 101 as drawn to non-patentable subject matter.
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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