Ex Parte Wald et al

Patent Trial and Appeal Board

Nov 15, 2017

11944062 (P.T.A.B. Nov. 15, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/944,062 11/21/2007 Lawrence L. Wald 125141.00012(MGH3273) 4625
26710 7590
QUARLES & BRADY LLP
Attn: IP Docket
411 E. WISCONSIN AVENUE
SUITE 2350
MILWAUKEE, WI 53202-4426
EXAMINER
COOK, CHRISTOPHER L
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
11/17/2017 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 LAWRENCE L. WALD, THOMAS WITZEL,
and BRUCE R. ROSEN1
Appeal 2016-005740
Application 11/944,062
Technology Center 3700
Before DONALD E. ADAMS, TAWEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for producing an image of bioelectromagnetic activity in a subject
with a magnetic resonance imaging (MRI) system, which have been rejected
as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
“Functional magnetic resonance imaging (fMRI) technology provides
an approach to study neuronal activity.” (Spec. 1 6.) According to the
1 Appellants identify the Real Party in Interest as The General Hospital
Corporation and Massachusetts Institute of Technology. (Br. 1.)
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Application 11/944,062
Specification, “[i]n conventional fMRI, mapping the eloquent cortex relies
on blood oxygen level dependent (BOLD) contrast. The physiological basis
of BOLD signal is the regional vasoactive response induced by neuronal
activity, causing increases in regional cerebral blood flow, blood oxygen
concentration, and consequently, measured [magnetic resonance] signal.”
(Id.) Further according to the Specification, however, such conventional
fMRI mapping technique have disadvantages “due to the indirect nature of
measuring neural activity through the BOLD effect.” (Id. 17.) In particular,
“the BOLD effect in response to a functional task exhibits a large temporal
delay on the order of several seconds and additional spatial misregistration
between the physical location of the firing neurons and the observed
hemodynamic changes can exist.” (Id.) The Specification states that, “[a]s a
result, a more direct means for detecting neuronal activity is desirable.” (Id.)
Claims 1 and 3—12 are on appeal. Claim 1, the only independent
claim, is illustrative and reproduced below with key limitations emphasized:
1. A method for producing an image of bioelectromagnetic
activity in a subject with a magnetic resonance imaging (MRI)
system, the steps comprising:
a) acquiring Tip -weighted image data from the subject using a
pulse sequence that directs the MRI system to perform a spin-lock
preparatory pulse sequence prior to acquiring nuclear magnetic
resonance (NMR) image data, wherein the spin-lock preparatory pulse
sequence includes applying a spin-lock radio frequency (RF) field,
B\p, that establishes a spin-lock condition in transverse spin
magnetization such that transverse spin magnetization in the spin-
lock condition is rotated by bioelectromagnetic fields directly
produced by neuronal activity in the subject,
b) reconstructing an image with the acquired Tip -weighted
image data; and
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c) analyzing image signals in the Tip -weighted image to detect
locations of neuronal activity in the subject.
(Br. A-l (Claims App.).)
The Examiner rejects claims 1 and 3—12 under pre-AIA 35 U.S.C.
§ 103 as obvious over Hulvershom,2 Konn3 or Pell,4 McFadden,5 and
Reddy.6 (Final Act. 2—3.)
DISCUSSION
Issue
The Examiner finds that Hulvershom discloses almost all of the
limitations of claim 1, except that in Hulvershom’s method the transverse
spin magnetization in the spin-locked condition is not rotated by
bioelectromagnetic fields “directly” produced by a subject’s neuronal
activity as claimed. (Final Act. 3^4; Ans. 2.) Instead, the Examiner
explains that Hulvershom teaches an “indirect” approach for measuring
neuronal activity where “the spin-locked magnetization is affected by
magnetic field fluctuations produced by changes in oxygenated blood
volume secondary to neuronal activity.” (Final Act. 3—4)
2 Justin Hulvershom et al., TJp Contrast in Functional Magnetic Resonance
Imaging, 54 Magnetic Resonance in Med. 155 (2005).
3 Daniel Konn et al., MRI Detection of Weak Magnetic Fields Due to an
Extended Current Dipole in a Conducting Sphere: A Model for Direct
Detection of Neuronal Currents in the Brain, 50 Magnetic Resonance in
Med. 40 (2003).
4 Gaby S. Pell et al., Further Steps Toward Direct Magnetic Resonance
(MR) Imaging Detection of Neural Action Currents: Optimization of MR
Sensitivity to Transient and Weak Currents in a Conductor, 55 Magnetic
Resonance in Med. 1038(2006).
5 Johnjoe McFadden, Synchronous Firing and Its Influence on the Brain’s
Electromagnetic Field, 9 J. Consciousness Studies 23 (2002).
6 Reddy et al., US 2003/0218459 Al, published Nov. 27, 2003.
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The Examiner finds, however, that Konn and Pell both teach the
disadvantages of conventional MRI methods for indirectly detecting
neuronal activity, such as those relying on “blood oxygen level-dependent
(BOLD) contrast to detect the change in intensity of regions of an image due
to the effects of neuronal activity on blood flow, volume, and oxygenation.”
{Id. at 4—5; Ans. 4.) The Examiner further finds that McFadden teaches that
mammalian brain waves are typically in the 0-100 Hz frequency range,
while Reddy teaches that a spin-lock frequency may be set from 0—600 Hz.
(Final Act. 6; Ans. 4.) The Examiner accordingly concludes that a skilled
artisan at the time of the invention would have been motivated to modify the
spin lock frequency in Hulvershom’s method to match the frequency of the
neuronal currents disclosed in McFadden, in order to “establish a spin-lock
condition rotated by bioelectromagnetic fields ‘directly’ produced [by]
neuronal activity” and thus “directly” detect neuronal activity. (Final Act. 5;
Ans. 3—4.)
Appellants contend that a skilled artisan would not have had reason to
modify Hulvershom as proposed by the Examiner, because the proposed
modification would change Hulvershom’s principle of operation. (Br. 11—
12.) Appellants further contend that a skilled artisan would not have had a
reasonable expectation of success of arriving at the claimed invention. {Id.
at 5, 9.) Appellants contend that the proposed combination of prior art is
based on impermissible hindsight reconstmction. {Id. at 11.) Finally,
Appellants contend that secondary considerations of non-obviousness,
including long-felt need and unexpected results, support the non­
obviousness of the claims. {Id. at 5—10.)
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The issue with respect to this rejection is whether a preponderance of
the evidence of record supports the Examiner’s conclusion that claim 1 is
obvious over Hulvershom, Konn or Pell, McFadden, and Reddy.
Analysis
On the record before us, we agree with Appellants that the Examiner
has not shown that a skilled artisan would have had a reasonable expectation
of success at arriving at the claimed invention.
In particular, Appellants contend that there is no reasonable
expectation that the small electromagnetic fields created by neuronal
currents were sufficiently strong to enable acquisition of a Tip -weighted
image data capable of being used to “detect locations of neuronal activity in
[a] subject.” (Br. 6; see also id. at 8.)
The Examiner responds that the combination of the prior art would
have been obvious to try because (1) Konn and Pell showed that there is a
recognized need in the art to measure neuronal activity directly; (2)
McFadden and Reddy demonstrated that there are a finite number of
identified, predictable solutions, and (3) “the teachings of Reddy and
McFadden would offer one skilled in the art a reasonable expectation of
success.” (Ans. 6 (emphasis omitted); see also id. at 4 (citing KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398 (2007)).)
We are not persuaded. We acknowledge that, “[wjhen there is a
design need or market pressure to solve a problem and there are a finite
number of identified, predictable solutions, a person of ordinary skill has
good reason to pursue the know options within his or technical grasp.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 402 (2007). Nevertheless, as
discussed further below, in this case, the Examiner has not persuasively
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shown that the invention of claim 1 is a “predictable” solution to the
problem of directly measuring neuronal activity.
The Examiner states in conclusory fashion that the teachings of Reddy
and McFadden, regarding setting a spin-lock frequency from 0—600 Hz and
regarding 1—100 Hz as the typical frequency range of mammalian brain
waves, render the invention of claim 1 predictable and provide a skilled
artisan a reasonable expectation of success in modifying the spin lock
frequency in Hulvershom’s method to arrive at the claimed invention. (Ans.
4, 6.) These statements are not persuasive.
Specifically, the Examiner fails to explain how such teachings from
Reddy and McFadden render the claimed invention “predictable” or provide
a reasonable expectation of success. KSR Int’l Co. v. Teleflex Inc., 550 U.S.
398, 418 (2007) {quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)
(“[R]ejections 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.”). In this regard, we note that McFadden is not directed to
MRI technology. Fikewise, while Reddy relates to Tip -weighted MRI
(Reddy Abstract), including imaging of the brain {id. 169), Reddy does not
appear directed to fMRI or detecting neuronal currents.
Our reviewing court has stated:
The admonition that “obvious to try” is not the standard under
§ 103 has been directed mainly at two kinds of error. In some cases,
what would have been “obvious to try” would have been to vary all
parameters or try each of numerous possible choices until one
possibly arrived at a successful result, where the prior art gave either
no indication of which parameters were critical or no direction as to
which of many possible choices is likely to be successful. ... In
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others, what was “obvious to try” was to explore a new technology or
general approach that seemed to be a promising field of
experimentation, where the prior art gave only general guidance as to
the particular form of the claimed invention or how to achieve it.
In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). In our opinion, the
Examiner’s reasoning falls within the second kind of error set forth in
O ’Farrell, wherein the art relied upon by the Examiner suggests, at best, the
exploration of “a promising field of experimentation” with no more than
“general guidance as to the particular form of the claimed invention or how
to achieve it.”
Accordingly, we reverse the Examiner’s rejection of claim 1 as
obvious over Hulvershom, Konn or Pell, McFadden, and Reddy. We also
reverse the Examiner’s rejection of claims 3—12, which depend directly or
indirectly from claim 1. In re Fine, 837 F.2d 1071, 1076, 5 USPQ2d 1596,
1600 (Fed. Cir. 1988) (“Dependent claims are nonobvious under section 103
if the independent claims from which they depend are nonobvious.”).
SUMMARY
For the reasons above, we reverse the Examiner’s decision rejecting
claims 1 and 3—12.
REVERSED
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