Ex Parte Parl et al

Patent Trial and Appeal Board

Apr 5, 2018

11854321 (P.T.A.B. Apr. 5, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111854,321 09/12/2007 Fritz F. Par!
32885 7590 04/09/2018
STITES & HARBISON PLLC
401 COMMERCE STREET
SUITE 800
NASHVILLE, TN 37219
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.
l l 672N/0726US 4661
EXAMINER
HALVORSON, MARK
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
04/09/2018 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):
richard.myers@stites.com
francine. vanaelst@stites.com
rachel. shelton@stites.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FRITZ F. P ARL, PHILIP S. CROOKE, MARYLYN D. RITCHIE,
DAVID L. HACHEY, SHEILA DA WLING, and NADY ROODI 1
Appeal2016-007791
Application 11/854,321
Technology Center 1600
Before ROBERT A. POLLOCK, TIMOTHY G. MAJORS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the non-final
rejection of claims 1-24. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
Appellants' invention relates to a method of assessing breast cancer
risk, which takes into account genotypic and phenotypic information relating
to exposure to carcinogenic estrogen metabolites 40HE2 and E2-3,4-Q.
1 Appellants identify the Real Party in Interest as Vanderbilt University.
App. Br. 1.
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Application 11/854,321
Spec. 5:3-22, Abstract. According to Appellants, the invention, as claimed,
uses statistics to analyze subject data. App. Br. 2. The method thereby
"determines that a subject has an increased risk of developing breast cancer
if there is an increased production of 4-0HE2 and/or E2-3,4-Q produced by a
determined allelic profile as compared to a mean population by the relevant
genetic population." Id. Conversely, "[t]he subject is determined to have a
decreased risk of developing breast cancer if there is a decreased population
of 4-0HE2 and/or E2-3,4-Q produced by the determined allelic profile as
compared to the mean population by the relevant genetic population." Id.
Claim 1 is representative (formatted):
1. A method for assessing a female subject's risk for
developing breast cancer comprising:
(a) determining, in a sample from said subject, the allelic
profile ofCOMT, CYPlAl and CYPlBl;
(b) predicting, based on an in silica model of estrogen
biosynthesis, relative amounts of 4-0HE2 and/or E2-
3 ,4-Q produced by the determined allelic profile;
( c) comparing the relative amounts of 4-0HE2 and/ or E2-
3 ,4-Q produced by the determined allelic profile to a
mean production amount of 4-0HE2 and/or E2-3,4-Q of
a relevant genetic population;
(d) determining that the subject has an increased risk of
developing breast cancer if there is an increased
production of 4-0HE2 and/or E2-3,4-Q produced by the
determined allelic profile as compared to the mean
production by a the [sic] relevant genetic population;
and
( e) determining that the subject has a decreased risk of
developing breast cancer if there is a decreased
production of 4-0HE2 and/or E2-3,4-Q produced by the
determined allelic profile as compared to the mean
production by a the [sic] relevant genetic population.
2
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Depending from claim 1, claim 8 "further compris[ es] assessing one
or more aspects of the subject's personal history." Also depending from
claim 1, claim 9 recites,
wherein said one or more aspects are selected from the group
consisting of age, ethnicity, reproductive history, menstruation
history, use of oral contraceptives, body mass index, alcohol
consumption history, smoking history, exercise history, diet,
family history of breast cancer or other cancer including the age
of the relative at the time of their cancer diagnosis, and a personal
history of breast cancer, breast biopsy or DCIS, LCIS, or atypical
hyperplasia. 2
STATEMENT OF THE REJECTION
Claims 1-24 stand rejected under 35 U.S.C. § 101 as drawn to non-
statutory subject matter.
35 U.S.C. § 101
We have reviewed Appellants' contentions that the Examiner erred in
rejecting claims 1-24 as drawn to non-statutory subject matter under 35
U.S.C. § 101. App. Br. 9-14. We disagree with Appellants' contentions
and adopt the Examiner's findings and well-reasoned conclusion. See Ans.
2-11. We provide the following 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
obtain a patent therefor, subject to the conditions and requirements of this
2 As Appellants do not address the subject matter of the dependent claims,
they fall with claim 1. Nevertheless, in the event of further prosecution, we
suggest that the Examiner consider whether there is sufficient antecedent
support for all dependent claim elements.
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Application 11/854,321
title." Supreme Court precedents, however, provide three specific
exceptions to the broad categories of eligible subject matter under § 101:
laws of nature, natural phenomena, and abstract ideas. Bilski v. Kappas, 561
U.S. 593, 625 (2010). "The 'abstract ideas' category embodies 'the
longstanding rule that '[a]n idea of itself is not patentable."' Alice Corp.
Pty. v. CLS Bank Int 'l, 134 S. Ct. 2347, 2355 (2014) (quoting Gottschalk v.
Benson, 409 U.S. 63, 67 (1972)). In Alice, the Supreme Court referred to the
two-step analysis set forth in Mayo Collaborative Services v. Prometheus
Laboratories, 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 Alice, "[ 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, ... 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.").
With respect to step one of the Mayo/Alice analysis, Appellants argue
that the claims "are not nature-based" because "predicting an individual
subject's future risk for a serious disease ... represents a practical
application of the research on which it is based." App. Br. 12. We do not
find that argument persuasive.
First, the claims regarding assessing a subject's risk of developing a
disease at issue here are similar to the multistep claims of assessing a
subject's risk of disease or developing a complication of a particular disease
found to be directed to a law of nature in Cleveland Clinic v. True Health
Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017). In that case, the Federal
Circuit noted that
the testing patent [claims] purport to detect MPO and other
MPO-related products, which are naturally occurring in bodily
samples. The [claimed] method then employs the natural
relationship between those MPO values and predetermined or
control values to predict a patient's risk of developing or having
cardiovascular disease.
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Cleveland Clinic, 859 F.3d at 1361. The Court further noted that those
claims are directed to a natural law because they
Id.
start[] and end[] with naturally occurring phenomena with no
meaningful non-routine steps in between-the presence of
MPO in a bodily sample is correlated to its relationship to
cardiovascular disease.
Furthermore, we note that just because an invention "effectuate[ s] a
practical result and benefit not previously attained," does not immunize it
from invalidity under§ 101 of the Patent Statute. Ariosa, 788 F.3d at 1381
(J. Reyna concurring) (citation omitted); see also Intellectual Ventures I LLC
v. Symantec Corp., 838 F.3d 1307, 1315 (Fed. Cir. 2016) ("'[t]he 'novelty'
of any element or steps in a process, or even of the process itself, is of no
relevance in determining whether the subject matter of a claim falls within
the § 101 categories of possibly patentable subject matter.' Diamond v.
Diehr, 450 U.S. 175, 188-89 (1981) (emphasis added); see also Mayo, 132
S.Ct. at 1303---04 (rejecting 'the Government's invitation to substitute
§§ 102, 103, and 112 inquiries for the better established inquiry under
§ 101 ')").
We are compelled to agree with the Examiner that the claims on
appeal are drawn to a natural phenomenon or law of nature, in particular, a
relationship between genotypic information relating to a subject's estrogen-
metabolizing enzymes (COMT, CYPlAl and CYPlBl), and the likelihood
that she has an increased or decreased risk for breast cancer as compared to a
relevant population. See Ans. 2-3. This naturally occurring relationship
exists apart from any human action, regardless of the statistical model used
to manipulate the data and correlate the genotypic information with a risk
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assessment. In short, the claims at issue focus on a fact of human biology,
involve no creation or alteration of the genotype or phenotype of the subject,
and do not purport to identify novel detection techniques. See, e.g., Genetic
Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376 (Fed. Cir. 2016)
(concluding that a method directed to detecting a coding allele was directed
to a patent-ineligible law of nature because it "focuses on a newly
discovered fact about human biology (the linkage of coding and non-coding
regions of DNA), involves no creation or alteration of DNA sequences, and
does not purport to identify novel detection techniques"). Moreover, steps
of collecting and analyzing information by steps people go through in their
minds, or by mathematical algorithms, such as are involved in the claims at
issue here, without more, are "mental processes within the abstract-idea
category." FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1093
(Fed. Cir. 2016).
With respect to step 2 of the Mayo/Alice framework, Appellants argue
that "the active method steps of the claims are not known in the art," yet
admit that the Examiner "had previously cited Mitrunen et al. and Yager et
al, as disclosing measuring CYPlAl, CYPlBl and COMT polymorphisms,"
as well as "Hanna et al., Ritchie et al., and Dawling et al., as disclosing
measurements of enzymatic activity of allelic variants ofCYPlAl, CYPlBl
and COMT proteins." App. Br. 13-14; see also Ans. 5 (citing references).
Appellants further argue that
the mere knowledge in the art of the existence of enzymatic
activity of CYPlAl, CYPlBl and/or COMT allelic variants
does not establish that it was conventional for scientists in the
field of the present invention( s) to evaluate the specifically
claimed allelic profile of COMT, CYPlAl and CYPlBl in the
context of the claimed method(s) to assess a subject's risk for
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developing breast cancer and/or for determining the need for
routine diagnostic testing of a female subject for breast cancer.
Id. at 14.
We do not find Appellants' arguments persuasive. We are, instead,
satisfied that the Examiner correctly considered the claim elements both
individually and as an ordered combination to determine whether they
transform the nature of the claim into a patent-eligible application. See Ans.
5-7, 9-10. As noted by the Examiner, "[t]he active method step of claim 1,
'determining in a sample from a subject, the allelic profile of COMPT,
CYPlAl and CYPlBl' is recited at a high level of generality such that
substantially all practical applications are covered. In addition, the step
relies on well-understood, routine and conventional methods." Ans. 5.
In addition, the method steps for determining in a sample
from a subject, the allelic profile of COMPT, CYPlAl and
CYP 1 B 1 such as amplifying nucleic acid from the sample by
PCR on a chip are conventional well understood routine
methods for determining allelic profiles. These steps are the
activities that a scientist would have relied upon to achieve the
goals of the invention. Thus, in the present case, the active
method steps set forth well-understood routine and
conventional activity engaged in by scientists and are the
activities that a scientist would have relied upon to determine
the allelic profiles of COMPT, CYPlAl and CYPlBl.
Id. at 6. Considering the claims as a whole, the individual steps fail to
provide significantly more than the judicial exception itself. See id. at 7; see
also Mayo 132 S. Ct. 1289, 1298 ("[T]he claims inform a relevant audience
about certain laws of nature; 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."). In sum, the
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claims before us merely inform the relevant audience of certain laws of
nature: specifically, the relationship between a patient's allelic profile and
the patient's risk of developing breast cancer. See Cleveland Clinic, 859
F .3 d at 13 62 (concluding that claims of a method that relate the natural
phenomena of MPO being associated with cardiovascular risk are not
directed to a patentable invention because the process steps of
detecting/ determining MPO levels and comparing the levels to statistically
derived control or predetermined values, whether considered limitation-by-
limitation or as a whole "merely tell those 'interested in the subject about the
correlations that the researchers discovered.' Mayo, 566 U.S. at 78"); see
also Genetic Techs., 818 F.3d at 1379--80 (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 also argue that, "when viewed as a whole, the claims do
not seek to tie up any judicial exception such that others cannot practice it."
App. Br. 11. We do not find Appellants' arguments persuasive. "[T]he
absence of complete preemption does not demonstrate patent eligibility."
Ariosa, 788 F.3d at 1379. "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."
Id.
For the above reasons, and those set forth in the Examiner's Answer,
we sustain the rejection.
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SUMMARY
We affirm the rejection of claims 1-24 under 35 U.S.C. § 101 as
drawn to non-statutory 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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