INSERM (Institut National de la Sante et de la Recherche Medicale) et al.

Patent Trials and Appeals Board

Dec 22, 2020

2020002426 (P.T.A.B. Dec. 22, 2020)

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
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/869,438 01/12/2018 Philippe Rouet 11450304US2 9857
30743 7590 12/22/2020
W&C IP
11491 SUNSET HILLS ROAD
SUITE 340
RESTON, VA 20190
EXAMINER
COUNTS, GARY W
ART UNIT PAPER NUMBER
1641
MAIL DATE DELIVERY MODE
12/22/2020 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte PHILIPPE ROUET, FATIMA SMIH-ROUET,
FRANCK DESMOULIN, and MICHEL GALINIER
____________

Appeal 2020-002426
Application 15/869,438
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 9–16 (Non-Final Act.2 2). We have jurisdiction
under 35 U.S.C. § 6(b). We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “INSERM
(INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE
MEDICALE) of Paris, France; UNIVERSITE PAUL SABATIER
TOULOUSE III of Toulouse, France; and CENTRE HOSPIT ALIER
UNIVERSIT AIRE DE TOULOUSE of Toulouse, France” (Appellant’s
August 26, 2019 Appeal Brief (Appeal Br.) 3).
2 Examiner’s March 27, 2019 Non-Final Office Action.
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STATEMENT OF THE CASE
Appellant’s disclosure:
[R]elates to a method for classifying a patient at risk for heart
failure, wherein said method comprises the steps of (i)
measuring the concentration of IGFBP2 in a sample obtained
from said patient and (ii) comparing the concentration of
IGFBP2 measured in step (i) to a control value derived from the
concentration of IGFBP2 in samples from patients who are at
particular stages of heart failure and/ or to a control value
derived from the concentration of IGFBP2 in blood samples
from healthy patients.
(Spec.3 1:5–11). Appellant’s claims 9 and 12 are reproduced below:
9. A method of treating heart failure in a patient in need
thereof, comprising the steps of:
a) obtaining a biological sample from said patient;
b) measuring the concentration of IGFBP2 in the sample
obtained in step a);
c) determining the severity of the heart failure depending
on the concentration of IGFBP2 measured in step b); and
d) administering to said patient diagnosed as having heart
failure an appropriate medication for a subject suffering
from heart failure depending on the severity of the heart
failure as determined in step c).
(Appeal Br. 19–20.)
12. The method according to claim 9, wherein the biological
sample obtained in step a) is a urine sample.
(Id.)

3 Appellant’s February 12, 2018 Specification.
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Grounds of rejection before this Panel for review:
Claims 9–11 and 14 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination Hassfeld,4 Ebrahim,5 and Todd.6
Claims 12, 13, 15, and 16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination Hassfeld, Ebrahim, Todd, and
McPherson.7
Claims 9–16 stand provisionally rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1, 4–9, 11, and 13–17 of copending Application 14/895,076.
Claims 9–16 stand rejected under 35 U.S.C. § 101.

OBVIOUSNESS:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Hassfeld discloses a method, wherein patient blood samples were
obtained and “serum levels for IGF1, IGF2, IGFBP2, IGFBP3, growth
hormone and growth hormone binding protein were determined by specific
radio-immunoassays” (Hassfeld 359; see Ans. 4).

4 Hassfeld et al., Insulin-like growth factor-binding proteins 2 and 3 are
independent predictors of a poor prognosis in patients with dilated
cardiomyopathy, 93 Heart 359–60 (2007).
5 Ebrahim et al., US 2006/0183681 A1, published Aug. 17, 2006.
6 Todd et al., US 2014/0206632 A1, published July 24, 2014.
7 McPherson et al., US 2015/0119269 A1, published Apr. 30, 2015.
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FF 2. Hassfeld discloses “that the growth hormone/IGF-system is
differently altered in patients with [congestive heart failure (CHF)] due to
different causes and might influence the course of the disease” (Hassfeld
359; see Ans. 4).
FF 3. Hassfeld discloses “that low IGF1 and IGFBP3 levels and high
IGFBP2 levels are associated with a worse prognosis in patients with CHF
due to idiopathic dilated cardiomyopathy” (Hassfeld 359–360; see Ans. 4).
FF 4. Examiner finds that Hassfeld fails to disclose “determining the
severity of the heart failure depending on the concentration of the
biomarker” (Ans. 4).
FF 5. Ebrahim discloses that “[p]lasma concentrations of the fragments of
pro [B-type natriuretic peptide (BNP)] are increased in patients with CHF
and have been shown to accurately predict clinical severity and left
ventricular ejection fraction as well as morbidity and mortality in patients”
and that “this indicator of CHF disease severity has been used to diagnose
and classify the severity of the congestive heart failure” (Ebrahim ¶¶ 1 and
5; see generally Ans. 5).
FF 6. Ebrahim discloses that “the New York Heart Association
classification of CHF, the mean concentrations of BNP progressively
increase from stage I to IV . . . of congestive heart failure” (Ebrahim ¶ 5; see
Ans. 5).
FF 7. Examiner finds that the combination of Hassfeld and Ebrahim fails
to disclose “the administration of medical care for a subject suffering from
heart failure” (Ans. 5).
FF 8. Examiner relies on Todd to disclose “that it is known and
conventional in the art to treat those subjects with heart failure with an
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amount of angiotensin-converting enzyme inhibitor (see Ans. 5 (citing Todd
¶ 89)).
FF 9. Examiner finds that the combination of Hassfeld, Ebrahim, and Todd
fails to suggest obtaining a plasma or urine sample or that the biomarker
“measurement is done by a set of antibodies or performed by ELISA” (Ans.
6).
FF 10. Examiner relies on McPherson to disclose the use of urine or plasma
samples “for detecting biomarkers such as IGFPB2,” “can be measured by
sandwich immunoassay,” and “that ELISA’s can be utilized to measure the
biomarker” (Ans. 6 (citing McPherson ¶¶ 13, 14, 30, 32, 44, 46–48, 55, and
84–86).
ANALYSIS
The rejection over Hassfeld, Ebrahim, and Todd:
Examiner recognizes “that Hassfeld fails to specifically teach
determining the severity of the heart failure depending on the concentration
of the [IGFBP2] biomarker,” but finds that because
Hassfeld specifically teaches that IGFP2 levels are higher when
associated with a worse prognosis patients in CHF and one of
ordinary skill in the art would recognize that the higher the
level the worse the prognosis and thus one or ordinary skill in
the art would look to known methods of classification and as
shown by Ebrahim it is well known in the art to utilize the
NYHA stages I-IV (NOTE: this is the same classification as
claimed in current claim 10) with the progression of the
concentration of a biomarker to classify the severity of heart
failure and that it would have been obvious to one of ordinary
skill in the art at the time the invention was made to incorporate
NYHA stages with increased concentrations of IGFBP2 in the
method of Hassfeld because Ebrahim et al shows that the
classification by NYHA stages I-IV and progression of
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concentration of a biomarker is well known and conventional in
the art.
(Ans. 14–15.) Thus, based on the combination of Hassfeld, Ebrahim, and
Todd, Examiner concludes that, at the time Appellant’s invention was made,
it would have been prima facie obvious “to incorporate NYHA stages with
increased concentrations of IGFBP2 in the method of Hassfeld because
Ebrahim . . . shows that the classification by NYHA stages I-IV and
progression of concentration of a biomarker is well known and conventional
in the art” (Ans. 5). Examiner, therefore, reasons that “absent evidence to
the contrary one of ordinary skill in the art would have a reasonable
expectation of success incorporating classification stages such as taught by
Ebrahim . . . into the method of Hassfeld” (id.).
Examiner further concludes that, at the time Appellant’s invention
was made, it would have been prima facie obvious
to incorporate a treatment such as taught by Todd . . . into the
modified method of Hassfeld because Todd . . . shows that it is
known in the art that subjects suffering from heart failure are
treated with a medication. Thus, one of ordinary skill in the art
would have a reasonable expectation of success incorporating
medication treatment into the modified method of Hassfeld.
(Id.)
We are not persuaded.
As Peacock explains,
Hassfeld does not provide a link of IGFBP2 to severity of heart
failure and thus the person of ordinary skill in the art would not
be motivated to include IGFBP2 in any method involving the
determination of severity of heart failure, including any such
method disclosed in Ebrahim . . . . Ebrahim relates to the use of
natriuretic peptides as a biomarker for heart failure. Ebrahim
does not mention IGFBP2. Due to the unpredictability of the
art, one of ordinary skill in the art would not assume that since
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one disease marker (natriuretic peptides) may also be useful for
determining disease severity, that any other potential disease
marker would be useful for determining disease severity.
(Peacock Decl.8 ¶ 6; see also Appeal Br. 14.) Stated differently, although
Hassfeld discloses a binary association between high IGFBP2 levels and “a
worse prognosis in patients with CHF due to idiopathic dilated
cardiomyopathy” (FF 3), Examiner failed to establish an evidentiary basis on
this record to support a conclusion that Hassfeld relates the severity of the
heart failure to the concentration of IGFBP2 measured in patient’s biological
sample such that a person of ordinary skill in this art would have found it
prima facie obvious that IGFBP2 concentrations would progressively
increase from CHF stage I to IV (see FF 3). Ebrahim’s disclosure relating to
a different biomarker, BNP, fails to make up for this deficiency in Hassfeld
(see FF 6 (Ebrahim discloses that “the New York Heart Association
classification of CHF, the mean concentrations of BNP progressively
increase from stage I to IV . . . of congestive heart failure.”)).
We agree with Appellant’s contention that Examiner’s reliance on
Todd, to disclose the treatment of subjects with heart failure, “does not
compensate for the deficiencies [in the combination] of Hassfeld and
Ebrahim” discussed above (Appeal Br. 16).

The rejection over Hassfeld, Ebrahim, Todd and McPherson:
Based on the combination of Hassfeld, Ebrahim, Todd, and
McPherson, Examiner concludes that, at the time Appellant’s invention was
made, it would have been prima facie obvious to substitute a plasma or urine

8 W. Franklin Peacock Declaration, signed February 15, 2019.
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sample, for the blood sample, in the method suggested by the combination of
Hassfeld, Ebrahim, and Todd, “because McPherson et al teaches that it is
known in the art to utilize samples such as serum, plasma and urine” and,
therefore, “absent evidence to the contrary one of ordinary skill in the art
would have a reasonable expectation of success incorporating plasma or
urine as the sample in the modified method of Hassfeld” (Ans. 6).
Examiner further concludes that, at the time Appellant’s invention
was made, it would have been prima facie obvious “to substitute sandwich
formats or ELISA tests such as taught by McPherson . . . for the
immunoassay of Hassfeld because McPherson . . . shows that it is well
known and conventional in the art to utilize sandwich assay formats and
ELISA for the detection/measurement of biomarkers such as IGFBP2” (id. at
7).
We are not persuaded. Examiner’s reliance on McPherson to disclose
the use of urine or plasma samples “for detecting biomarkers such as
IGFPB2,” “can be measured by sandwich immunoassay,” and “that ELISA’s
can be utilized to measure the biomarker,” fails to make up for the
deficiencies in the combination of Hassfeld, Ebrahim, and Todd discussed
above (see FF 10; cf. Appeal Br. 16 (Appellant contends that
“McPherson . . . does not compensate for the deficiencies” in the
combination of Hassfeld, Ebrahim, and Todd)).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
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The rejection of claims 9–11 and 14 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Hassfeld, Ebrahim, and Todd is
reversed.
The rejection of claims 12, 13, 15, and 16 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Hassfeld, Ebrahim, Todd, and
McPherson is reversed.

SUBJECT MATTER ELIGIBILITY:
ISSUE
Does the preponderance of evidence of record support Examiner’s
finding that Appellant’s claimed invention is directed to patent-ineligible
subject matter?
PRINCIPLES OF LAW
A. Section 101
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.
However, the U.S. Supreme Court has long interpreted 35 U.S.C. § 101 to
include implicit exceptions: “[l]aws of nature, natural phenomena, and
abstract ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l, 573
U.S. 208, 216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Court’s two-part framework, described in Mayo and Alice.
Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
566 U.S. 66, 75–77 (2012)). In accordance with that framework, we first
determine what concept the claim is “directed to.” See Alice, 573 U.S. at
219 (“On their face, the claims before us are drawn to the concept of
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intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging, or protecting
against risk.”).
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611);
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and
mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 191
(1981)); “tanning, dyeing, making water-proof cloth, vulcanizing India
rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267–68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Court held that “a claim drawn to subject matter otherwise statutory does not
become nonstatutory simply because it uses a mathematical formula.”
Diehr, 450 U.S. at 187; see also id. at 191 (“We view respondents’ claims as
nothing more than a process for molding rubber products and not as an
attempt to patent a mathematical formula.”). Having said that, the Court
also indicated that a claim “seeking patent protection for that formula in the
abstract . . . is not accorded the protection of our patent laws, and this
principle cannot be circumvented by attempting to limit the use of the
formula to a particular technological environment.” Id. (citation omitted)
(citing Benson and Flook); see, e.g., id. at 187 (“It is now commonplace that
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an application of a law of nature or mathematical formula to a known
structure or process may well be deserving of patent protection.”).
If the claim is “directed to” an abstract idea, we turn to the second
step of the Alice and Mayo framework, where “we must examine the
elements of the claim to determine whether it contains an ‘inventive
concept’ sufficient to ‘transform’ the claimed abstract idea into a patent-
eligible application.” Alice, 573 U.S. at 221 (internal quotation marks
omitted). “A claim that recites an abstract idea must include ‘additional
features’ to ensure ‘that the [claim] is more than a drafting effort designed to
monopolize the [abstract idea].’” Id. (alterations in original) (quoting Mayo,
566 U.S. at 77). “[M]erely requir[ing] generic computer implementation[]
fail[s] to transform that abstract idea into a patent-eligible invention.” Id.
B. USPTO Section 101 Guidance
In January 2019, the U.S. Patent and Trademark Office (USPTO)
published revised guidance on the application of § 101. 2019 Revised Patent
Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019)
(“Guidance”).9 “All USPTO personnel are, as a matter of internal agency
management, expected to follow the guidance.” Id. at 51; see also October
2019 Update at 1.

9 In response to received public comments, the Office issued further
guidance on October 17, 2019, clarifying the 2019 Revised Guidance.
USPTO, October 2019 Update: Subject Matter Eligibility (the “October
2019 Update”) (available at https://www.uspto.gov/sites/default/files/
documents/peg_oct_2019_update.pdf).
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Under the Guidance and the October 2019 Update, we first look to
whether the claim recites:
(1) any judicial exceptions, including certain groupings of
abstract ideas (i.e., mathematical concepts, certain methods of
organizing human activity such as a fundamental economic
practice, or mental processes) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into
a practical application (see MPEP §§ 2106.05(a)–(c), (e)–(h)
(9th ed. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).10
Guidance, 84 Fed. Reg. at 52–55.
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look, under
Step 2B, to whether the claim:
(3) adds a specific limitation beyond the judicial exception that
is not “well-understood, routine, conventional” in the field (see
MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional
activities previously known to the industry, specified at a high
level of generality, to the judicial exception.
Guidance, 84 Fed. Reg. at 52–56.
ANALYSIS
(Step 1)
We first consider whether the claimed subject matter falls within the
four statutory categories set forth in § 101, namely “[p]rocess, machine,

10 This evaluation is performed by (a) identifying whether there are any
additional elements recited in the claim beyond the judicial exception, and
(b) evaluating those additional elements individually and in combination to
determine whether the claim as a whole integrates the exception into a
practical application. See Guidance — Section III(A)(2), 84 Fed. Reg. at
54–55.
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manufacture, or composition of matter.” Guidance, 84 Fed. Reg. at 53–54;
see 35 U.S.C. § 101. The method set forth in Appellant’s claims falls within
the four statutory categories set forth in § 101 (see Appeal Br. 20).
Therefore, we proceed to the next steps of the analysis.
(Step 2A, Prong 1)
Appellant’s claimed method comprises, inter alia, as step (c), the
determination of “the severity of [a patient’s] heart failure depending on the
concentration of IGFBP2” in a patient’s biological sample (see Appeal Br.
20). Examiner finds that Appellant’s “claims are directed to a naturally
occurring correlation between the concentration of IGFBP2 in [a] patient
having heart failure” (Ans. 7). We find no error in Examiner’s finding that
Appellant’s claim recites a natural law (see id.).
(Step 2A, Prong 2)
Having determined that Appellant’s claims recite a judicial exception
involving a natural law, the Guidance requires an evaluation as to whether
the claim as a whole integrates the recited judicial exception into a practical
application of the exception. See Guidance, 84 Fed. Reg. at 54.
Steps (a) and (b) of Appellant’s claimed method require that a
biological sample is obtained from a biological sample and that the IGFBP2
concentration in this sample is measured, respectively (see Appeal Br. 20).
The collection and measurement of a component in a sample are
insignificant extra-solution activities that are insufficient to confer patent
eligibility. See, e.g., Guidance, 84 Fed. Reg. at 55, n. 31 (citing Mayo, 566
U.S. at 79).
Step (d) of Appellant’s claimed method, however, requires the
administration “to said patient diagnosed as having heart failure an
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appropriate medication for a subject suffering from heart failure depending
on the severity of the heart failure as determined in step c)” of the claimed
method (see Appeal Br. 20). The evidence of record establishes that those of
ordinary skill in this art understand the appropriate medication that should be
administered to those suffering from heart failure depending on the severity
of the heart failure (see, e.g., Spec. 13–18; Todd ¶ 91 (“[T]reating the patient
that has a risk of CHF, or has CHF, . . . [to] prevent CHF, prevent or slow
the progression of CHF, and avoid or prolong hospital admission for
CHF”)). As the Guidance explains that “an additional element that applies
or uses a judicial exception to effect a particular treatment or prophylaxis for
a disease or medical condition” is “an additional element (or combination of
elements) [that] may have integrated the exception into a practical
application.” See Guidance, 84 Fed. Reg. at 55 (footnotes omitted); see also
id. n. 26 (citing Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d
1117, 1135 (Fed. Cir. 2018) (holding claims to the practical application of
the natural relationships between iloperidone, CYP2D6 metabolism, and
QTc prolongation to treat schizophrenia, not merely the recognition of those
relationships, to be patent eligible at Mayo/Alice step 1 (USPTO Step 2A)),
and USPTO Vanda Memorandum (discussing Vanda)); see also Appeal Br.
8–9.
For the foregoing reasons, we are not persuaded by Examiner’s
assertion that Appellant’s “administration step is not particular, and is
instead merely instructions to ‘apply’ the exception in a generic way” and,
thus, “the administration step does not integrate the mental analysis step into
a practical application” (Ans. 13). On this record, we find that Appellant’s
claims integrate the judicial exception into a practical application.
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(Step 2B)
Even if Appellant’s claimed invention did not integrate the judicial
exception into a practical application, as discussed above, we find that when
the elements of Appellant’s claimed invention are considered individually
and in combination, Appellant’s claims add a specific limitation beyond the
judicial exception that is not “well-understood, routine, conventional” in the
field. See Guidance, 84 Fed. Reg. at 52–56. Specifically, for the reasons
discussed above with respect to the obviousness rejection, we find that
Examiner failed to establish an evidentiary basis on this record to support a
finding that the correlation between IGFBP2 concentration in a biological
sample and severity of heart failure was well-understood, routine,
convention in this field.
CONCLUSION
The preponderance of evidence of record fails to support Examiner’s
finding that Appellant’s claimed invention is directed to patent ineligible
subject matter. The rejection of claims 9–16 under 35 U.S.C. § 101 is
reversed.

OBVIOUSNESS-TYPE DOUBLE PATENTING:
Appellant does not contest Examiner’s provisional rejection of
Appellant’s claims 9–16 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1, 4–9,
11, and 13–17 of co-pending Application 14/895,076 (see Appeal Br. 19).
Instead, Appellant contends that it “will address this issue once the final
disposition of the present claims and/or those of 14/895,076 is determined,
e.g. by filing a Terminal Disclaimer if necessary” (id.). Stated differently,
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Appellant waived any appeal of this rejection. Therefore, we decline to
address the merits of this provisional obviousness-type double patenting
rejection. See In re Moncla, 95 USPQ2d 1884, 1885 (BPAI 2010)
(precedential).

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
9–11, 14 103 Hassfeld, Ebrahim,
Todd
9–11, 14
12, 13, 15, 16 103 Hassfeld, Ebrahim,
Todd, McPherson
12, 13, 15,
16
9–16 Provisional
Obviousness-type
Double Patenting11

9–16 101 Eligibility 9–16
Overall
Outcome
9–16

REVERSED

11 As explained above, we do not reach this rejection per Ex parte Moncla,
95 USPQ2d 1884 (BPAI 2010) (designated precedential).