Ex Parte Pfeiffer et al

Patent Trial and Appeal Board

Dec 7, 2018

13722393 (P.T.A.B. Dec. 7, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/722,393 12/20/2012
30452 7590 12/07/2018
EDWARDS LIFESCIENCES CORPORATION
LEGAL DEPARTMENT
ONE EDWARDS WAY
IRVINE, CA 92614
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Ulrich Pfeiffer
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.
CCHDM-6174-DV 1033
EXAMINER
JANG, CHRISTIAN YONGKYUN
ART UNIT PAPER NUMBER
3791
MAIL DATE DELIVERY MODE
12/07/2018 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 ULRICH PFEIFFER and REINHOLD KNOLL
Appeal2017-007240
Application 13/722,393 1
Technology Center 3700
Before JEFFREY N. FRED MAN, CHRISTOPHER G. P AULRAJ and
DAVID COTTA, Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to an apparatus for determining a circulatory fill status of a patient. The
Examiner rejected the claims on appeal under 35 U.S.C. § 101 as not
directed to patent eligible subject matter.
We affirm.
1 According to Appellants, the real party in interest is Edwards Lifesciences
IPRM AG. App. Br. 3.
Appeal2017-007240
Application 13/722,393
STATEMENT OF THE CASE
According to the Specification, "[i]t is generally known that in the
critical-care[,] diagnosis[,] and treatment of extremely sick persons, cardiac
output CO (i.e. blood flow) and circulatory fill volume of a patient's
circulatory system are important characteristics for monitoring the patient's
state of health." Spec. ,r 3. The Specification discloses that "[ t ]he present
invention provides an apparatus for determining a patient's circulatory fill
status, wherein the apparatus is adapted to provide a dilution curve and is
capable of deriving the ratio between the patient's global end-diastolic
volume GEDV and the patient's intra thoracic thermo volume ITTV from
the dilution curve." Id. ,r 26.
Due to the fact that . . . the present invention determin[ es] the
patient's circulatory fill status by making use of dilution ...
based on the ratio between the patient's global end-diastolic
volume GEDV and the patient's intra thoracic thermo volume
ITTV, the patient's circulatory fill status can be determined
accurately.
Id. ,I 29.
Claims 1--4 and 6-9 are on appeal. Claim 1 is illustrative and reads as
follows:
1. An apparatus for determining a circulatory fill status of a
patient comprising:
a device configured to:
measure, over a period of time, a concentration of
an indicator at a location of a patient's systemic
circulation, the location being downstream from an
injection point associated with a vena cava superior of the
patient;
generate a dilution curve representing the
concentration of the indicator over the period of time
based at least in part on said measurement, the dilution
curve having an area;
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Application 13/722,393
App. Br. 24.
determine a ratio between a median transit time
(MDT) and a mean transit time (MTT) based at least in
part on the dilution curve;
determine a ratio between a global end-diastolic
volume (GEDV) of the patient and an intra thoracic
thermo volume (ITTV) of the patient based at least in part
on the MDT and the MTT; and
determine a circulatory fill status of the patient
based at least in part on the ratio between the GEDV and
the ITTV of the patient;
wherein the MDT is defined as being a time at
which half of the dilution curve area is reached and the
MTT is defined as being a time indicated by a center of
mass of the dilution curve area.
The Examiner rejected claims 1--4 and 6-9 under 35 U.S.C. § 101 as
directed to patent ineligible subject matter.
ANALYSIS
Determination of subject matter eligibility involves a two-step test.
First one must determine if the claimed subject matter is directed to a
judicially recognized exception. Mayo Collaborative Serves, v. Prometheus
Lab., Inc. 566 U.S. 66, 77-78 (2012). If the claims address a judicially
recognized exception, the next step is to determine if the claims recite
additional elements that transform the nature of the claim. Id.
Claim 1
In rejecting claim 1 as directed to patent-ineligible subject matter, the
Examiner determined that claim 1 was directed to "the abstract idea of a
mathematical relationship or formula." Final Act. 2. 2 The Examiner
identified the mathematical relationship recited in claim 1 as being "a ratio
2 Office Action mailed March 23, 2016 ("Final Act.").
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Application 13/722,393
between GEDV and ITTV as a function of a ratio between MDT and MTT"
as well as "a ratio between GEDV and ITTV." Id. The Examiner then
determined that the additional elements recited in claim 1 amounted to no
more than "a generic device configured to carry out the abstract idea, or
mere instructions to implement the idea on a generic computer." Id.
Accordingly, the Examiner determined that these additional claim elements
did not "transform the abstract idea into a patent eligible application of the
abstract idea such that the claim[] amount[ s] to significantly more than the
abstract idea itself." Id. at 3.
We agree with the Examiner that claim 1 is directed to patent
ineligible subject matter. We address Appellants' arguments below.
Appellants argue that the Examiner "merely states that the claim
features 'make use of a mathematical formula"' without sufficient
explanation of why the features of claim 1 correspond to that formula. App.
Br. 11. We are not persuaded.
The Examiner specifically identified the claim steps that were found
to comprise the mathematical relationship, namely, "the determination of a
ratio between GEDV and ITTV as a function of a ratio between MDT and
MTT, as well as determining a circulatory fill status on the basis of a ratio
between GEDV and ITTV." Final Act. 2. The Examiner also explained that
the claim was "wholly directed to data gathering and processing." Ans. 3.
This was sufficient to identify the subject matter that the Examiner
considered to be directed to a judicial exception. Nothing more was required
to put Appellants on notice of the basis for the Examiner's rejection.
Appellants argue that a claim is not patent ineligible simply because it
"'makes use of' a mathematical formula." App. Br. 12. Appellants argue
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Application 13/722,393
that the subject matter of claim 1 is patent eligible because, like the subject
matter found patent eligible in Enfzsh LLC v. Microsoft Corp., 822 F.3d
1327 (Fed. Cir. 2016), it is directed to a specific improvement. App. Br. 12-
13. Appellants contend that although claim 1 recites "certain 'ratios,"' the
claim as a whole is directed to "specific and significant improvements in
determining circulatory fill status of a patient through monitoring injected
concentrations" and thus "claim 1 is not directed to a judicial exception." Id.
at 13. We are not persuaded.
In Enfzsh, the claims were directed to a "data storage and retrieval
system for a computer memory." Enfish, 822 F.3d at 1336. The Federal
Circuit concluded that the claims at issue were not directed to an abstract
idea, but to a "specific improvement to the way computers operate,
embodied in the self-referential table." Id. Here, the claims are directed to
an apparatus for determining a circulatory fill status of a patient. The
claimed apparatus comprises a generic computer and a device for measuring
the concentration of an indicator. Appellants do not allege, and we do not
find, that the claims provide an improvement to the recited computer or
measuring device. Rather, as the Examiner explained, the claims are
"wholly directed to data gathering and processing." Ans. 3.
We find that this case is more closely analogous to Electric Power
Group LLC. v. Alstom SA, 830 F.3d 1350 (Fed. Cir. 2016) than to Enfzsh. In
Electric Power, the Federal Circuit considered the patent eligibility of claims
directed to "systems and methods for performing real-time performance
monitoring of an electric power grid by collecting data from multiple data
sources, analyzing the data, and displaying the results." Electric Power, 830
F .3 d at 13 51. The court concluded that the focus of the claims was on patent
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Application 13/722,393
ineligible subject matter because "[t]he advance they purport to make is a
process of gathering and analyzing information of a specified content, then
displaying the results, and not any particular assertedly inventive technology
for performing those functions." Id. at 1354. Here, as in Electric Power, the
advance the claims seek to protect is in the process of gathering and
analyzing information rather than the technology used for performing this
function.
Appellants further argue that claim 1 is similar to the claims in
Diamond v. Diehr, 450 U.S. 175 (1981), which Appellants characterize as
requiring "(1) constantly determining temperature; (2) repetitive
calculations and comparisons; and (3) opening a press based on the
calculations." App. Br. 15-16. Appellants contend that claim 1, like the
claims in Diehr, amounts to significantly more than the patent-ineligible
mathematical operation. Id. We are not persuaded because, as the Examiner
explained,
[i]n Diehr, the claimed invention results in a physical
transformation of matter, and the recited equation is used as part
of the application resulting in this transformation. In the instant
claims, the claims are wholly directed to the abstract idea, and
insignificant extra-solution activities of data collection and
processing using generic elements.
Ans. 3.
Appellants argue that the claims amount to "significantly more"
because they "provide meaningful limits on the use of the claimed
determination of ratios" and "do[] not tie up the determination of the ratios
recited in the claim, but merely the determination of the ratios in the context
of the additional limitations included in the claim ( e.g., "measuring ... ;
generating ... ; determining a circulatory fill status ... ;" etc.)." App. Br.
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16, 1 7. We are not persuaded because, even if one can find other
meaningful uses of the claimed ratios, "the absence of complete preemption
does not demonstrate patent eligibility." Ariosa Diagnostics, Inc. v.
Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015). Moreover, the claims
are quite broad, imposing no limitations on how the concentration of the
indicator is measured or how the dilution curve based on the concentration is
generated.
Appellants argue that the claimed apparatus "is patent eligible based
on its improvement of existing technological processes; namely, circulatory
fill status measurement and patient monitoring processes." App. Br. 18.
Appellants contend that the claimed apparatus "improves these technologies
by improving the accuracy of circulatory fill status measurement and
improving the reliability of patient monitoring." Id. at 19.
Our reviewing court has made clear that a difference exists between
patent ineligible claims, as here, that focus "on asserted advances in uses to
which existing computer capabilities could be put" and patent eligible claims
that focus "on a specific improvement ... in how computers could carry out
one of their basic functions of storage and retrieval of data." Electric Power
Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354 (Fed. Cir. 2016),
discussing Eefzsh, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36 (Fed.
Cir. 2016). We do not find, and Appellants do not identify, such a
technological advance- e.g., "using less processor power and memory
space" - in Appellants' claimed invention. Research Corp., 627 F.3d at 865.
Our reviewing court has further made clear that the relative
importance of an alleged invention is not determinative of whether the
subject matter claimed is patent-eligible. For example, the Federal Circuit
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rejected an argument similar to that raised by Appellants in Ariosa
Diagnostics, Inc. v. Sequenom Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2004). In
that case, the Federal Circuit found that an improvement in pre-natal
screening did not justify patentability, explaining:
Sequenom also notes that "the method reflects a significant
human contribution in that [Drs.] Lo and Wainscoat combined
and utilized man-made tools of biotechnology in a new way that
revolutionized prenatal care." Id. We agree but note that the
Supreme Court instructs that "[g]roundbreaking, innovative, or
even brilliant discovery does not by itself satisfy the § 101
inquiry." Myriad Genetics, Inc., 133 S.Ct. at 2117. The discovery
of the BRCAl and BRCA2 genes was a significant contribution
to the medical field, but it was not patentable. Id. at 2117. While
Drs. Lo and Wainscoat's discovery regarding cfIDNA may have
been a significant contribution to the medical field, that alone
does not make it patentable. We do not disagree that detecting
cfIDNA in maternal plasma or serum that before was discarded
as waste material is a positive and valuable contribution to
science. But even such valuable contributions can fall short of
statutory patentable subject matter, as it does here.
Ariosa Diagnostics, 788 F.3d at 1379-1380. Thus, even accepting
Appellants' assertion that the claimed apparatus significantly improves
existing technology, this alone does not render the apparatus patentable
subject matter.
Appellants argue that the patentability of the claimed subject matter is
demonstrated by the "indication of Allowable Subject matter in the [Final]
Office Action," which states: "the prior art of record fails to teach, or fairly
suggest, in combination with all other recited limitations, the derivation of a
ratio between GEDV and ITTV as a function of a ratio between MDT and
MTT." App. Br. 21; Final Act. 3. We are not persuaded.
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Although "in evaluating the significance of additional steps, the § 101
patent-eligibility inquiry and, say, the § 102 novelty inquiry might
sometimes overlap," Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 566 U.S. 66, 90, (2012), these inquiries are not the same.
If the novelty of the claim lies in the abstraction, law of nature, or other
unpatentable subject matter, the claim may be novel or nonobvious and yet
still fail under § 101. See Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788
F.3d 1371, 1377 (Fed. Cir. 2015) ("For process claims that encompass
natural phenomenon, the process steps are the additional features that must
be new and useful."); Parker v. Flook, 437 U.S. 584, 591 (1978) ("The
process itself, not merely the mathematical algorithm, must be new and
useful.").
Appellants argue that the "measuring ... ," "generating ... ," and
"determining ... ," steps are "part of the solution that allows for accurate
and reliable circulatory fill status determination" and thus these steps are not
"merely 'extra-solution activity."' App. Br. 21-22. We are not persuaded
because, as discussed above, the solution the claims purport to provide lies
in a process of gathering and analyzing information and not in the
technology used for performing the claimed solution.
Appellants argue that "determining a ratio between MDT and MTT
for use in determining circulatory fill status ... represents a method of
determining circulatory fill status that is based on novel parameters that are
unconventional in the art."3 App. Br. 22. Appellants contend that the use of
3 Appellants do not assert that any of the other elements of claim 1 are
unconventional or not routine in the art. This is consistent with the
Specification, which indicates that the device used to "measure ... a
concentration" is part of the "current state of the art" and that the "device for
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MDT and MTT "represents an inventive contribution by the inventors." Id.
We are not persuaded because, the "determining" steps are part of the
mathematical relationship identified by the Examiner. Therefore, they
cannot add significantly more to the patent ineligible subject matter, i.e., the
mathematical relationship. Accordingly, we affirm the Examiner's rejection
of claim 1 as directed to patent ineligible subject matter.
Claim 6
Appellants argue the patent eligibility of claim 6 under a separate
heading but rely exclusively on the arguments raised in connection with
claim 1. App. Br. 23. Accordingly, we affirm the Examiner's rejection of
claim 6 for the reasons discussed in connection with claim 1.
Claims 2--4 and 7-9
Claims 2--4 depend from claim 1, and claims 7-9 depend from claim
6. Appellants argue the patent eligibility of claims 2--4 and 7-9 under a
separate heading and contend that these claims are patentable "for at least
the same reasons articulated above with respect to their respective base
claims, and because of the additional features recited therein." App. Br. 23
( emphasis added). The emphasized language in the preceding statement is
insufficient to raise the issue of whether the "additional features" recited in
calculating such equations" is shown in prior art U.S. patent 5,526,817. See,
Spec. ,r 4 ("According to the current state of the art the cardiac output CO
can be determined by using a dilution measurement. ... Based on the
indicator concentration c response measurement versus time t the dilution
curve is generated by plotting the indicator concentration c response as a
function of time t.") id. ,r 56 ("A device for calculating such equations may
be for example similar to that shown in U.S. 5,526,817, hereby incorporated
by reference herein, with a processor or computer programmed to run the
program described herein.").
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dependent claims 2--4 and 7-9 lend patent eligibility to those claims. See In
re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) ("[T]he Board [has]
reasonably interpreted Rule 41.3 7 to require more substantive arguments in
an appeal brief than a mere recitation of the claim elements and a naked
assertion that the corresponding elements were not found in the prior art.").
Accordingly, we affirm the Examiner's rejection of claim 2--4 and 7-9 for
the reasons discussed in connection with claim 1.
SUMMARY
For these reasons and those set forth in the Examiner's Answer and
Final Office Action, we affirm the Examiner's rejection of claims 1--4 and
6-9 under 35 U.S.C. § 101 as not directed to patent eligible subject matter.
AFFIRMED
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