Ex Parte Frederick et al

Patent Trial and Appeal Board

Feb 7, 2018

13701567 (P.T.A.B. Feb. 7, 2018)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/701,567 02/18/2013 Blaise Frederick 146822.00006 4818
26710 7590 02/09/2018
QUARLES & BRADY LLP
Attn: IP Docket
411 E. WISCONSIN AVENUE
SUITE 2350
MILWAUKEE, WI 53202-4426
EXAMINER
HOFFMAN, JOANNE M
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
02/09/2018 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):
pat-dept@quarles.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BLAISE FREDERICK and YUNJIE TONG
Appeal 2017-001651
Application 13/701,567
Technology Center 3700
Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER, and
KRISTI L. R. SAWERT, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a
computer-implemented method for measuring at least one of blood flow or
volume in a subject. The Examiner rejected the claims as lacking patent
utility and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.
Statement of the Case
Background
“Measuring blood flow in organs is useful in a variety of diagnostic
and therapeutic procedures. Magnetic resonance imaging (MRI) can be used
for such measurements” (Spec. 1).
1 Appellants identify the Real Party in Interest as the McLean Hospital
Corporation (see App. Br. 1).
Appeal 2017-001651
Application 13/701,567
Blood oxygenation level-dependent functional MRI (BOLD
fMRI) reflects changes in local blood oxygenation levels and
volume in various parts of an organ. On the other hand, near-
infrared spectroscopy (NIRS) is an imaging modality that tracks
temporal changes in oxygenation and total hemoglobin level at
a given portion of the body.
{Id. at 2). The “invention is based, at least in part, on the discovery that
patterns of oxygenation and total hemoglobin detected using NIRS can be
matched with a BOLD fMRI pattern in an area of interest.... This
information can be used to map blood flow through the organ” {id. at 2).
The Claims
Claims 37—47 and 54—56 are on appeal. Independent claim 37 is
representative and reads as follows:
37. A computer-implemented method for measuring at least
one of blood flow or volume in a subject, the method
comprising:
receiving functional magnetic resonance imaging (fMRI)
data that provides information on at least one of volume or
oxygenation of blood at one or more locations in a body over a
first predetermined length of time;
receiving spectroscopic measurement data representing at
least one of blood concentration or oxygenation at a first
portion of the body over a second predetermined length of time;
deriving, from the fMRI data corresponding to a second
portion of the body, a time varying data set representing
changes in at least one of blood oxygenation or volume at a
second portion of the body over the first predetermined length
of time;
determining a time delay and a value of a similarity
metric corresponding to a part of the spectroscopic imaging
data that most closely matches the time varying data set, the
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time delay representing a difference between a first time in
which blood flows from a third portion in the body to the first
portion and a second time in which blood flows to the second
portion from the third portion, and the value of the similarity
metric representing an amount of blood at the second portion;
and
determining, based on the time delay and the value of the
similarity metric, an estimate of a characteristic of at least one
of blood flow or blood volume in the second portion at a given
time.
The Issues
A. The Examiner rejected claims 37, 38, 40, 47, and 54 under 35 U.S.C.
§ 103(a) as obvious over Huppert2 and Gupta3 (Final Act. 6—10).
B. The Examiner rejected claim 39 under 35 U.S.C. § 103(a) as obvious
over Huppert, Gupta, and Bryskhe4 (Final Act. 10).
C. The Examiner rejected claims 41—44, 46, 55, and 56 under 35 U.S.C.
§ 103(a) as obvious over Huppert, Gupta, and Sassaroli5 (Final Act. 10—13).
D. The Examiner rejected claim 45 under 35 U.S.C. § 103(a) as obvious
over Huppert, Gupta, and Dan6 (Final Act. 13—14).
2 Huppert et al., A temporal comparison of BOLD, ASL, and NIRS
hemodynamic responses to motor stimuli in adult humans, 29 NeuroImage
368-82 (2006).
3 Gupta et al., Dynamic programming based time-delay estimation technique
for analysis of time-varying time-delay, 81 Rev. Scientific Instruments 1—
8 (2010).
4 Bryskhe et al., WO 2008/147326 Al, published Dec. 4, 2008.
5 Sassaroli et al., Spatially weighted BOLD signal for comparison of
functional magnetic resonance imaging and near-infrared imaging of the
brain, 33 NeuroImage 505-14 (2006).
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Application 13/701,567
E. The Examiner rejected claims 37-47 and 54—56 under 35 U.S.C.
§ 101 as lacking patentable subject matter (Final Act. 5—6).
A. 35 U.S.C. § 103(a) over Huppert and Gupta
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Huppert and Gupta suggest
“determining, based on the time delay and the value of the similarity metric,
an estimate of a characteristic of at least one of blood flow or blood volume”
using fMRI and spectroscopic data as required by claim 37?
Findings of Fact
1. Huppert teaches performing “simultaneous near-infrared
spectroscopy (NIRS) along with BOLD (blood oxygen level dependent) and
ASL (arterial spin labeling)-based fMRI during an event-related motor
activity in human subjects in order to compare the temporal dynamics of the
hemodynamic responses recorded in each method” (Huppert 368, Abstract)
2. Huppert teaches the each fMRI “run lasted 6 min and consisted
of between 27 and 32 stimulus periods. This was repeated 4—6 times for
each subject during the course of one scan session (approximately 90 min)
for both the ASL and BOLD measurements” (Huppert 370, col. 1).
3. Huppert teaches that for NIRS, “[ejpoch timing was
synchronized to the MRI images so that subject response times were kept
constant between the fMRI and NIRS” (Huppert 371, col. 1).
4. Huppert teaches that using NIRS “concentration data, the
individual subject hemodynamic responses were calculated using an
6 Dan et al., US 2007/0282189 Al, published Dec. 6, 2007.
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ordinary least-squares (OLS) linear deconvolution and implemented within
the HomER program” (Huppert 371, col. 1).
5. The Examiner acknowledges “Huppert does not teach explicitly
... a time delay and the time delay representing a difference between a first
time and a second time” (Final Act. 7).
6. Gupta teaches “beam emission spectroscopy (BES) diagnostic
in fusion plasmas has not only provided the measurements and
understanding of plasma turbulence but has also served as a tool to measure
and study the local magnetic field and beam-plasma interactions” (Gupta 1,
col. 1).
7. Gupta teaches for beam emission spectroscopy diagnostic in
fusion plasmas “spatially separated time-series signals of density
fluctuations serve as carrier signals for the measurement of time-varying
time-delay” (Gupta 1, col. 2).
8. Gupta teaches the “technique will continue to provide useful
information in the field of plasma turbulence, and it can certainly be
extended to other branches of physics and science” (Gupta 8).
Principles of Law
“Prior art is analogous if it is from the same field of endeavor or if it is
reasonably pertinent to the particular problem the inventor is trying to
solve.” Circuit Checklnc. v. QXQInc., 795 F.3d 1331, 1335 (Fed. Cir.
2015). “The question is not whether simple concepts . . . are within the
knowledge of lay people or even within the knowledge of a person of
ordinary skill in the art. Rather, the question is whether an inventor would
look to this particular art to solve the particular problem at hand.” Id.
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Analysis
Appellants contend
Gupta constitutes non-analogous art. That is, the Examiner
provided no basis to explain why one of ordinary skill in the art
would stray from Huppert" s focus on comparing medical
imaging information into a reference, Gupta, that is focused on
measuring the poloidal velocity fluctuation in high temperature
tokamak plasmas using beam-emission-spectroscopy
diagnostic.
(App. Br. 23).
The Examiner responds “the [Gupta] reference is solving a similar
problem by using mathematics to develop a time-delay estimation. A time-
delay is common in many arts and using mathematics based on signals is
analogous art. And therefore these can be combine[d]” (Ans. 17). The
Examiner finds the “mathematical technique can be applied to the time-
delay for fMRI and NIRS as both are just signal processing and
understanding how signals interact and work within data and with hardware
and fluid moving” (Ans. 18).
We agree with Appellants that Gupta, drawn to analysis of plasmas
associated with the physics of nuclear fusion is neither in the same field of
endeavor as Huppert, nor pertinent to problems with which the Specification
or Huppert were concerned (see App. Br. 23).
In particular, the Specification teaches: “Matching the fMRI data
with the NIRS data involves deriving a time course from the fMRI data of a
particular portion ... of the body part and determining if one or both of the
oxygenation and volume fluctuations in any part” (Spec. 15). The
Specification explains “the shape of the time course can represent a global
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blood oxygenation pattern that travels through the entire organ” (Spec. 16).
The Specification teaches that “the methods and systems described herein
can be used for assessing frontal and/or temporal lobe perfusion in suspected
Alzheimer’s disease” as well as “determining regions of ischemia and/or
bleeding in the brain in stroke patients” (Spec. 23). Thus, the problem with
which the Specification was concerned was to determine how changes in
oxygenation in human organs impact disease.
While Huppert is associated with blood oxygen levels (FF 1), Gupta is
entirely unrelated to any sort of biological or even chemical analysis but
rather is generally drawn to understanding of plasma turbulence in nuclear
fusion plasmas (FF 6).
When considering whether a reference is pertinent to the problem with
which the inventor or prior art were concerned, the framing of the problem
may well be determinative of the analogous art determination. If the
problem is broadly framed as the desire to perform signal analysis generally,
then Gupta has some degree of relevance generally to any signal analysis
process. However, this broad a framing is unreasonable, because under this
logic any reference dealing with a general concern will always be pertinent.
When the problem is framed at a more reasonable scale, whether
narrowly as comparing the temporal dynamics of the hemodynamic response
as Huppert suggests (FF 1), or more broadly as measuring the flow of a fluid
in a biological subject, Gupta lacks any indicia of relevance to these fields of
endeavor.
We are not persuaded by the Examiner’s finding that Gupta’s
“mathematical technique can be applied to the time-delay for fMRI and
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NIRS as both are just signal processing and understanding how signals
interact and work within data and with hardware and fluid moving” (Ans.
18). Certainly Gupta teaches time delay mathematical techniques (FF 7), but
Gupta is not analogous art that provides reasons for applying these time-
delay mathematical techniques into the medical process disclosed by
Huppert. Indeed, even in Gupta’s broad conclusion, Gupta focuses on
extending the techniques “to other branches of physics and science” (FF 8)
generally, without providing any reason why the techniques would be
pertinent to analysis of biological data such as fMRI or NIRS.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Huppert and Gupta suggest “determining, based on the time delay and
the value of the similarity metric, an estimate of a characteristic of at least
one of blood flow or blood volume” using fMRI and spectroscopic data as
required by claim 37.
B.-D. 35 U.S.C. § 103(a)
The Examiner relies upon Gupta for each of these rejections to teach
the time delay analysis limitation of independent claim 37 (see Final Act.
10-13). Having reversed the obviousness rejection of claim 37 over
Huppert and Gupta because Gupta is not analogous art for the reasons given
above, we also find that the further combinations with Bryskhe, Sassaroli,
and Dan do not render the rejected claims obvious for the same reason.
E. 35 U.S.C. §101
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The Examiner finds all of the claims on appeal unpatentable under 35
U.S.C. § 101 as being directed to patent-ineligible subject matter,
specifically the abstract “idea of data matching the natural phenomenon of
blood oxygenation/hemoglobin volume/concentration, which is a
mathematical algorithm/relationship fundamental in the practice of the art of
image analysis/modeling” (Final Act. 5). The Examiner finds the “claim
elements such as the data acquisition and manipulation ... do not provide
meaningful limitations to transform the abstract idea into a patent eligible
application of the abstract idea” (id.).
To determine whether a claim is invalid under § 101, we employ the
two-step Alice framework. In step one, we ask whether the claims are
directed to a patent ineligible concept, such as an abstract idea or law of
nature. Alice Corp. Pty. Ltd. v. CLSBankInt’l, 134 S. Ct. 2347, 2355
(2014); Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566
U.S. 66, 75—77 (2012); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d
1371, 1375 (Fed. Cir. 2015). While both method and computer readable
media claims are generally eligible subject matter, claims that are directed
only to abstract ideas and/or natural phenomena are directed to a patent
ineligible concept. Ariosa, 788 F.3d at 1376.
Alice Step One
Claim 37 of the instant application is directed to a method for
measuring blood flow or volume by analyzing data obtained by both fMRI
and spectroscopy that is then analyzed using two mathematical parameters,
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time delay and similarity metric. Claim 54 is a computer readable medium
incorporating the method of claim 37.
Taking up the first step of the patent-eligibility analysis, we note, “[a]t
some level, ‘all inventions . . . embody, use, reflect, rest upon, or apply laws
of nature, natural phenomena, or abstract ideas,”’ and whether one takes a
macroscopic or microscopic view of a claim may be determinative on the
issue. Alice, 134 S. Ct. at 2354. While “a mathematical formula like the
Arrhenius equation is not itself patent-eligible subject matter, even if limited
to a particular technological environment,” claims are patent eligible under
§101 “when a claim containing a mathematical formula implements or
applies that formula in a structure or process which, when considered as a
whole, is performing a function which the patent laws were designed to
protect.” Diamond v. Diehr, 450 U.S. 175, 191—2 (1981).
Claims 37 and 54 are closely analogous to claim 22 in Thales Visionix
Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017), which involved
determining an object’s orientation relative to a moving reference frame
using two inertial sensor. Id. at 1345. Just as the method in Thales “utilize
mathematical equations to determine the orientation of the object relative to
the moving reference frame,” id. at 1348, in claim 37 “matching an fMRI
time course and the NIRS signal is done by performing multiple general
linear model fits using versions of the NIRS signal advanced or delayed in
time” (Spec. 16). Both the Thales claims and the instant claims rely on
mathematical operations in association with devices that obtain relevant
information in a way that improves the accuracy of the underlying assay.
See Thales, 850 F.3d at 1348; Spec. 16—18.
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We therefore conclude that just as the Thales “claims seek to protect
only the application of physics to the unconventional configuration of
sensor,” Thales, 850 F.3d 1349, so too the instant claims seek to protect the
application of physics to a unconventional combination of fMRI and NIRS
signals to more accurately determine blood flow or volume. Therefore,
these claims are not directed to an abstract idea and thus the claims survive
Alice step one and are therefore patent eligible.
Alice Step Two
However, turning to the second step under Alice, we find the claims
patent eligible even if we agreed with the Examiner that the claims simply
relate to “a process that employs mathematical algorithms to manipulate
existing information to generate additional information is not patent
eligible.” Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d
1344, 1351 (Fed. Cir. 2014).
The facts and claimed subject matter here are analogous to those of
the recent Federal Circuit decision in Amdocs (Israel) Ltd. v. Openet
Telecom, Inc., 841 F.3d 1288 (Fed. Cir. 2016), which leads us to determine
that the claims recite the “something more” required by the Supreme Court
to transform an abstract idea into a patent-eligible invention. See also Alice,
134 S. Ct. at 2355. As in Amdocs, here, even if we conceded that claim 1
was directed to an abstract idea of analyzing data using mathematical
algorithms, claims 37 and 54 entails unconventional technical solutions by
combining fMRI and NIRS data in an approach that the Examiner has not
shown to be anticipated or obvious. This solution addresses a technological
problem (i.e., the difficulty in determining blood flow or volume without
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resorting tags and prior art issues with “low sensitivity, low resolution, and a
limitation on the duration of time that blood can be tracked due to loss of
coherence of tagged blood”). See Spec. 1; see also Amdocs, 841 F.3d at
1301. As in Amdocs, claims 37 and 54 ties the invention to a structure —
“fMRI imaging” and “spectroscopic measurement” and, indirectly therefore,
to MRI machines and spectrometers. See claim 37, supra', see also Amdocs,
841 F.3d at 1301. As in Amdocs, claims 37 and 54 are not drawn to preempt
the generic enhancement of data in similar systems, but are directed to
specific technological solutions needed for blood flow or volume analysis by
combining fMRI and NIRS data. See claim 37, supra', see also Amdocs, 841
F.3d at 1301. Considered as an ordered combination, we are not persuaded
that claims 37 and 54 recite an invention that is merely the routine or
conventional use of technology previously known to skilled persons.7
We therefore conclude that Supreme Court and Federal Circuit
precedent supports the conclusion that the claims on appeal are directed to
patent-eligible subject matter.
SUMMARY
In summary, we reverse the rejection of claims 37, 38, 40, 47, and 54
under 35 U.S.C. § 103(a) as obvious over Huppert and Gupta.
We reverse the rejection of claim 39 under 35 U.S.C. § 103(a) as
obvious over Huppert, Gupta, and Bryskhe.
7 We note that our reversal of the obviousness rejection supports this
position.
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We reverse the rejection of claims 41—44, 46, 55, and 56 under 35
U.S.C. § 103(a) as obvious over Huppert, Gupta, and Sassaroli.
We reverse the rejection of claim 45 under 35 U.S.C. § 103(a) as
obvious over Huppert, Gupta, and Dan.
We reverse the rejection of claims 37-47 and 54—56 under 35 U.S.C.
§ 101 as lacking patentable subject matter.
REVERSED
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