Ex Parte Cales et al

Patent Trial and Appeal Board

Jun 25, 2018

13129999 (P.T.A.B. Jun. 25, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/129,999 09/02/2011
466 7590
YOUNG & THOMPSON
209 Madison Street
Suite 500
Alexandria, VA 22314
06/27/2018
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Paul Cales
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.
0727-1036-1 3821
EXAMINER
FRITCHMAN, REBECCA M
ART UNIT PAPER NUMBER
1797
NOTIFICATION DATE DELIVERY MODE
06/27/2018 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):
DocketingDept@young-thompson.com
yandtpair@firs ttofile. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAUL CALES,
CHRISTOPHE AUBE, and VINCENT ROULLIER
Appeal2017-007437
Application 13/129,999
Technology Center 1700
Before MICHAEL P. COLAIANNI, GEORGE C. BEST, and
N. WHITNEY WILSON, Administrative Patent Judges.
WILSON, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 appeal under 35 U.S.C. § 134(a) from the Examiner's
March 28, 2016 decision finally rejecting claims 1, 4, and 22-24. We have
jurisdiction over the appeal under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the real parties in interest as Universite d' Angers and
Centre Hospitalier Universitaire d' Angers (Appeal Br. 2).
Appeal2017-007437
Application 13/129,999
CLAIMED SUBJECT MATTER
Appellants' invention relates to the field of hepatic diagnosis (Spec.
1 :4). According to the Specification, the described in vitro non-invasive
method facilitates quantifying liver lesions, which are due or related to liver
impairment, liver steatosis, non-alcoholic fatty liver disease (NAFLD), or
nonalcoholic steatohepatitis (NASH) (id. at 1 :5-8). Claims 1 and 23 are
representative and are reproduced below from the Claims Appendix of the
Appeal Brief:
1. An in-vitro non-invasive method for quantifying lesions
of a liver of a patient, comprising:
obtaining a blood sample from the patient;
measuring the following five biomarkers in the blood
sample: glycemia, AST (aspartate aminotransferase), ALT
(alanine aminotransferase), ferritin, and platelets;
measuring the following two clinical markers in the
patient: age and weight;
combining said measures in a logistic function;
obtaining a score value reflecting the stage of liver
fibrosis and the quantification of liver lesions.
Appeal Br. 22 (Claims App.).
23. A method of quantifying fibrosis of a liver of a patient,
compnsmg:
obtaining a blood sample from the patient;
measuring the following five biomarkers in the blood
sample: glycemia, AST (aspartate aminotransferase), ALT
(alanine aminotransferase), ferritin, and platelets;
measuring the following two clinical markers in the
patient: age and weight;
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Application 13/129,999
performing binary logistic regression analysis combining
the seven measures of the five biomarkers and the two clinical
markers to calculate a score value; and
quantifying the fibrosis of a liver based on the score
value reflecting the stage of liver fibrosis.
Id. at 22-23.
REJECTIONS
(1) Claims 1, 4, and 22-24 are rejected under 35 U.S.C. § 101 as
directed to patent-ineligible subject matter.
(2) Claims 1, 4, and 22-24 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Maor2 in view of Callewaert, 3 and further in view of
Salonen. 4
The Examiner has withdrawn the rejection of claims 1 and 23 under
35 U.S.C. § 112, i-f 2, as indefinite (Ans. 5; see also Final Act. 2-3).
With respect to the rejections maintained by the Examiner, Appellants
do not make separate substantive arguments in support of patentability of
any of the claims (see generally Appeal Br. 12-21; Reply Br. 1-3).
Accordingly, our discussion will focus on the rejections of independent
claims 1 and 23. Claims 4, 22, and 24 will stand or fall with each of their
respective independent claims. 37 C.F.R. § 41.37(c)(l)(iv).
2 Y. Maor et al., "Improving estimation of liver fibrosis using combination
and newer noninvasive biomarker scoring systems in hepatitis C-infected
haemophilia patients," 13 Haemophilia 722-29 (2007).
3 Callewaert et al., US 2005/0112691 Al, published May 26, 2005.
4 Salonen et al., US 2007/0072798 Al, published Mar. 29, 2007.
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Application 13/129,999
Rejection I
DISCUSSION
The Examiner concludes that claims 1 and 23 are directed to two
judicial exceptions: (i) an abstract idea and (ii) a law of nature (Final Act. 4).
The Examiner further concludes that the claims are drawn "towards
performing statistical analysis, mathematical functions (logistic function,
binary logistic regression, etc.), ... which is [sic] a mental process/abstract
idea" (id. at 2). According to the Examiner, these claims are also "drawn
towards the measurement of naturally occurring 'markers' and correlating
these markers to the presence of disease" (id. at 3).
The Examiner determines that Appellants do not claim anything,
including "the mathematical/statistical analysis," "which is significantly
more/not conventional than" correlating naturally occurring markers to the
presence of disease (id. at 6, 3). Thus, the Examiner concludes that the
subject matter of claims 1 and 23 is within the scope of the judicially-created
exception that places abstract ideas and natural laws outside of the scope of
patent-eligible subject matter.
We agree with the Examiner that, under the two-step test of Alice
Corp. v. CLS Bank International, 134 S. Ct. 2347 (2014), claims 1and23
are not directed to patent-eligible subject matter. The Alice Court stated that
"[i]n Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566
U.S. [66] ... (2012), we 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." Alice Corp., 134 S. Ct.
at 2355.
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The Alice Court described the Mayo test as follows:
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. We have described
step two 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 amounts to
significantly more than a patent upon the [ineligible concept]
itself."
Id. (alterations in original, citations omitted).
Appellants make the following arguments urging reversal of the
Examiner's§ 101 rejection: (1) the claims amount to significantly more than
a logistic function because claims 1 and 23 require "the measurement in a
blood sample of five specific biomarkers and two specific clinical markers
and the combination of the values measured in a logistic function, with the
stated aim of obtaining a score value useful for the quantification of a liver
lesion," (Appeal Br. 13); (2) because "three biomarkers may each be
associated to a number of disorders[,] ... there is no direct correlation
between the ... seven markers recited in the present invention and the
presence of liver lesions" (id. at 14); (3) "measuring the five cited
biomarkers and the two cited clinical markers and combining them in a
specific mathematical function ... amounts to significantly more than
applying a law of nature" (id. at 14--15); and (4) the seven measured markers
are not "well-understood, routine or conventional in the field" (Reply Br. 2).
We are not persuaded by these arguments.
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Appellants' argument (2) is directed to the first step of the Alice/Mayo
test. In other words, Appellants argue that the Examiner reversibly erred in
determining that the claims at issue are directed to the patent-ineligible
concept of "applying a law of nature, a natural correlation" (Ans. 3; see also
Appeal Br. 14).
We note, however, Appellants admit that the claimed method
facilitates "quantifying liver lesions, especially due or related to liver
impairment, liver steatosis, non-alcoholic fatty liver disease (NAFLD), or
nonalcoholic steatohepatitis (NASH)" (Spec. 1:5-8 (emphasis added)). 5
Moreover, the Examiner finds that one of the three biomarkers allegedly
associated with a number of disorders, i.e., platelet count, is a known
biomarker related to liver fibrosis (Ans. 4 (citing Maor 722, col. 1); see also
Appeal Br. 14 ). 6 Thus, we agree with the Examiner that detecting the
claimed combination of naturally occurring 5 biomarkers and 2 clinical
markers informs a relevant audience of certain laws of nature: specifically,
that levels of certain biomarkers and clinical markers will differ in diseased
patients compared to normal patients based on the natural correlation.
Appellants' arguments (1), (3), and (4) are directed to the Examiner's
allegedly erroneous analysis of the claims under step two of the Alice/Mayo
test. However, we are unpersuaded that the Examiner erred by determining
5 Appellants further disclose that "several tests using non-invasive
biomarkers have already been developed and proposed for the diagnosis of
fibrosis," thereby admitting that the natural correlation between biomarkers
and hepatic disease was known (Spec. 2:26-28).
6 With regard to ferritin and blood glucose, Appellants do not direct our
attention to any authority that supports the proposition that the patent-
ineligible concept of natural correlation must distinguish between direct and
indirect correlations (Appeal Br. 14).
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that the additional elements recited in claims 1 and 23 fail to transform the
nature of these claims into patent-eligible subject matter.
With respect to argument ( 1) that the claims' additional elements
transform the nature of the claim from merely an abstract idea, "the
'prohibition against patenting abstract ideas cannot be circumvented by
attempting to limit the use of the formula to a particular technological
environment."' Mayo, 566 U.S. at 78 (citations omitted). Furthermore, the
Examiner correctly determined that "it would be obvious to one of ordinary
skill in the art to analyze data mathematically," e.g., through Appellant's
claimed statistical analysis (Ans. 7). 7 Thus, we are not persuaded that the
Examiner erred in concluding that claims 1 and 23 lack a sufficient inventive
concept to transform the abstract idea into patent-eligible subject matter.
With regards to arguments (3) and (4) that the claims' additional
elements transform the nature of the claim from simply applying a law of
nature, the Examiner correctly determined that Appellants have "not
transformed these markers from their natural state in the instant measuring"
steps (id.). As the Examiner concluded, by "detecting the combination of
the 7 markers ( 5 biomarkers, 2 clinical) ... [Appellants] ha[ ve] merely
recognized a natural law[] ... and applied it" (id.). Furthermore, Appellants
have not provided any persuasive technical reasoning or evidence to rebut
the Examiner's conclusion that "correlating these markers to the presence of
disease" is conventional and does not amount to anything "significantly
more" than the claiming of the natural correlation (see id. at 2-3; see also in
re Mayo, 566 U.S. at 73).
7 There is no dispute that Callewaert explicitly discloses logistic regression
analysis (Ans. 4 (citing Callewaert Figs. 3, 6; i-fi-f 11, 14); Appeal Br. 17).
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In sum, claims 1 and 23 encompass the use of known mathematical
algorithms to the measured amounts of seven known naturally occurring
markers to determine the amount of hepatic lesions, which are due or related
to liver disease. Such claims are not directed to patent-eligible subject
matter.
Accordingly, we affirm the rejection of claims 1, 4, and 22-24 as not
directed to patentable subject matter for the reasons set forth above. 37
C.F.R. § 41.37(c)(l)(iv).
Rejection II
Appellants do not dispute the Examiner's finding that Salonen
discloses two of the seven claimed markers, namely weight and ferritin
(Appeal Br. 19; Ans. 5). Rather, Appellants dispute the Examiner's
rationale for modifying Maor's non-invasive biomarker test for liver fibrosis
estimation by including Salonen's disclosed markers (Appeal Br. 19). In
particular, Appellants argue that because Salonen discloses other markers for
diagnosing cardiovascular or metabolic conditions, "a person skilled in the
art would have had no reason to combine [Salonen's] ferritin and weight
with the other markers of the invention in a logistic regression with the aim
to quantify a liver lesion" (id. at 19; see also id. at 18).
Appellants' arguments are persuasive.
It is well understood that "rejections on obviousness grounds cannot
be sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007) (quoting In re Kahn, 441F.3d977, 988 (Fed. Cir. 2006)). The
fact that a reference may be modified to reflect features of the claimed
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invention does not make the modification, and hence the claimed invention,
obvious unless the prior art suggested the desirability of such modification.
In re Mills, 916 F.2d 680, 682 (Fed. Cir. 1990).
The Examiner determines that "[i]t would have been obvious to one of
ordinary skill in the art to use the measurements and techniques of S [ alonen]
with the methods ofM[aor] and C[allewaert] due to the benefits these
methods offer with determining disease outcome" (Ans. 5 (citing Salonen
i-f 238)). However, the Examiner's relied upon disclosure does not mention
the benefits of including weight as a marker for hepatic disease diagnosis.
Furthermore, the Examiner has not provided adequate reasoning to explain
why a person of skill in the art would have modified Maor's non-invasive
biomarker test for estimating liver fibrosis in view of Salonen's body weight
marker, which is disclosed as related to cardiovascular and metabolic risk
(see Ans. 5, 9). Without such reasoning, the Examiner has not established a
prima facie case of obviousness.
Thus, Appellants' arguments have identified reversible error in the
Examiner's determination that Maor in view of Callewaert, and further in
view of Salonen, renders claims 1 and 23 obvious.
Accordingly, we reverse the obviousness rejection of claims 1, 4, and
22-24 for the reasons set forth above. 37 C.F.R. § 41.37(c)(l)(iv).
We express no opinion with respect to Appellants' other arguments
urging reversal of the Examiner's§ 103(a) rejection.
CONCLUSION
We AFFIRM the rejection of claims 1, 4, and 22-24 under 35 U.S.C.
§ 101 as directed to patent-ineligible subject matter.
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We REVERSE the rejection of claims 1, 4, and 22-24 under 3 5
U.S.C. § 103(a) as obvious over Maor in view of Callewaert, and further in
view of Salonen.
AFFIRMED
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