Ex Parte Bibian et al

Patent Trial and Appeal Board

Nov 15, 2017

14330408 (P.T.A.B. Nov. 15, 2017)

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.
NEUR-024 9615
EXAMINER
CATINA, MICHAEL ANTHONY
ART UNIT PAPER NUMBER
3735
MAIL DATE DELIVERY MODE
14/330,408 07/14/2014
81256 7590
NeuroWave Systems Inc.
4415 Euclid Avenue
Suite 500
Cleveland, OH 44103
11/15/2017
Stephane Bibian
11/15/2017 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 STEPHANE BIBIAN and TAT JANA ZIKOV1
Appeal 2016-008678
Application 14/330,408
Technology Center 3700
Before ULRIKE W. JENKS, TAWEN CHANG, and DAVID COTTA,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
methods for monitoring brain function or quantifying brain or cortical
activity in a subject as a function of depth of anesthesia, which have been
rejected under 35 U.S.C. § 101 as being directed to a judicial exception
without significantly more. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as NeuroWave Systems, Inc.
(Appeal Br. 2.)
Appeal 2016-008678
Application 14/330,408
STATEMENT OF THE CASE
“Quantitative electroencephalograph (QEEG) monitoring is a valuable
non-invasive tool for monitoring brain activity and detecting numerous
forms of neuropathological activity such as seizure and stroke.” (Spec.
1:20—22.) According to the Specification, however, “traditional QEEG
monitoring techniques focus on the subject’s brain as a whole, looking at
cortical/brain activity.” (Id at 1:22—24.) The Specification states that,
[wjhile this type of monitoring is very useful... for certain
procedures, such as measuring subject status with respect to sedation
or anesthesia . . ., it cannot always detect other problems or
conditions that may arise or exist within one particular brain
hemisphere or as a function of the communication between the two
brain hemispheres.
(Id. at 1:24—2:3.) Further according to the Specification, the present
invention relates to processing, monitoring, and displaying EEG signals
representing the cortical or brain activity of each of the subject’s brain
hemispheres and detecting changes in subject’s status. (Id. at 1:11—17.)
Claims 21—30, 32, and 34-40 are on appeal.2 Claim 21 is illustrative
and reproduced below:
21. A method of detecting a change in subject status with a device for
quantifying brain or cortical activity in the subject as a function of
depth of sedation or anesthesia comprising the steps of:
a. anesthetizing or sedating a subject;
b. monitoring the subject with a brain having a left hemisphere
and a right hemisphere, the subject under anesthesia or sedation
and being monitored with a device for quantifying brain or
cortical activity as a function of depth of sedation or anesthesia,
the device with at least two measurement electrodes, and at
least one reference electrode, the at least two measurement
2 The Examiner withdrew the rejection of claim 33 in the Answer. (Ans. 2.)
This claim is thus no longer part of this appeal.
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electrodes comprising at least one electroencephalogram (EEG)
electrode, having a signal, positioned to monitor left
hemisphere brain or cortical activity and at least one EEG
electrode, having a signal, positioned to monitor right
hemisphere brain or cortical activity of the subject’s brain, the
reference electrode comprising at least one EEG electrode, each
electrode providing an EEG analog signal which is
subsequently converted to a digital signal;
c. measuring the brain or cortical activity of both the subject’s left
and right brain hemispheres essentially simultaneously over a
period of time part of the period of time over which the subject
is under sedation or anesthesia;
d. calculating based in part on the digital signals with the
processor at least one numerical quantitative
electroencephalogram (QEEG) time-series index corresponding
to the brain or cortical activity as a function of depth of
anesthesia or sedation of each of the left and right hemispheres
of the subject’s brain over the period of time part of which the
subject is under sedation or anesthesia;
e. displaying the at least two numerical time-series indices, with at
least one numerical time-series index corresponding to the brain
or cortical activity of each of the left and the right hemispheres
over the period of time part of the period of time which the
subject is under sedation or anesthesia on a monitor
simultaneously;
f. comparing the numerical time-series indices of each
hemisphere’s cortical activity as a function of depth of
anesthesia or sedation; and
g. determining based on the calculated indices for each
hemisphere whether differences between the brain or cortical
activity of one hemisphere of the brain is indicative of a change
in subject status when compared to the brain or cortical activity
of the other hemisphere of the brain of the subject.
(Appeal Br. 17—18 (Claims App.).)
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Application 14/330,408
The Examiner rejects claims 21—30 and 32, and 34-40 under 35
U.S.C. § 101 as being directed to a judicial exception without significantly
more. (Final Act.3 2.)
DISCUSSION
Issue
The Examiner finds that claims 21—30, 32, and 34-40 are directed to
“determining indices for the brain hemispheres from the EEG and making a
determination based on these hemispheric indices.” (Final Act. 2.) The
Examiner further finds that the claims “do not include additional elements
that are sufficient to amount to significantly more than the judicial
exception”: “[T]he determination of the indices and display for
determination [are] no more than data manipulation and displaying
information both of [which] are considered abstract as the steps could be
performed mentally,” while “[t]he additional steps of. . . collecting the EEG
data and displaying it are routine in the art.” (Id. ) Appellants contend that
the claims are not directed to an abstract idea, a law of nature, or a general
concept. The issue with respect to this rejection is whether the claims are
directed to a judicial exception without more.
Principles of Law
In Mayo Collaborative Services v. Prometheus Laboratories,
Inc., 566 U.S. [66], 132 S.Ct. 1289 . . . (2012), the Supreme Court 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. First, we determine whether
the claims at issue are directed to a patent-ineligible concept. Id. at
1297. If the answer is yes, then we next consider the elements of each
3 Office Action mailed August 13, 2015 (“Final Act.”).
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Application 14/330,408
claim both individually and “as an ordered combination” to determine
whether additional elements “transform the nature of the claim” into a
patent-eligible application. Id. at 1298. The Supreme Court has
described the second step 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. at 1294.
Ariosa Diagnostics v. Sequenom, Inc. 788 F.3d 1371, 1375 (Fed. Cir. 2015)
(second bracket in original).
Analysis
Claim 21
We follow the analytical frameworks set forth by the Supreme Court
in Mayo and applied by our reviewing court in Ariosa. Under this rubric, we
agree with the Examiner that claim 21 is directed to a judicial exception
without more and thus not patentable under 35 U.S.C. § 101.
We begin our analysis at Mayo step one: “whether the claims at issue
are directed to a patent-ineligible concept.” Ariosa, 788 F.3d at 1375. We
find that the claims are directed to a patent-ineligible law of nature.
In Mayo, the claimed invention was a “method of optimizing
therapeutic efficacy for treatment of an immune-mediated gastrointestinal
disorder” comprising administering a certain class of drug and then
determining the level of 6-thioguanine (6-TG) in a patient, where a level of
6-TG below or above certain amounts indicated a need to increase or
decrease, respectively, the drag dosage. Mayo, 566 U.S. at 74-75.
Claim 21 of the instant application is similar, in that it is directed to a
method of determining whether there is a change in the status of a patient
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under anesthesia, by measuring and comparing the brain or cortical activity
of the left and right hemispheres of the brain.
The Mayo Court concluded that the claims at issue in that case “set
forth laws of nature—namely, relationships between concentrations of
certain metabolites in the blood and the likelihood that a dosage of a
thiopurine drug will prove ineffective or cause harm.” Id. at 77. Similarly,
claim 21 on appeal sets forth a law of nature—namely, the relationship
between comparative brain or cortical activities of the two hemispheres of
the brain and the status of a patient under anesthesia.
In light of our determination that the claims at issue are directed to a
natural law, we move to the second step of the Mayo analysis: whether
additional elements “transform the nature of the claim” into a patent-eligible
application. Ariosa, 788 F.3d at 1375.
The claims in Mayo included an “administering” step, a “determining”
step, and a “wherein” clause. Mayo, 566 U.S. 74-75. The Court concluded
that “[t]he upshot is that the three steps simply tell doctors to gather data
from which they may draw an inference in light of the correlations.” Id. at
79. In other words,
the claims inform a relevant audience about certain laws of nature:
any additional steps consist of well-understood, routine, conventional
activity already engaged in by the scientific community; and those
steps, when viewed as a whole, add nothing significant beyond the
sum of their parts taken separately.
Id. at 79-80. The Court concluded that “the steps are not sufficient to
transform unpatentable natural correlations into patentable applications of
those regularities.” Id. at 80.
Like the claims in Mayo, the manipulative steps of claim 21 on appeal
“consist of well-understood, routine, conventional activity already engaged
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in by the scientific community,'’ as shown by Callahan,4 5Bibian." and
Sarkela.6 Id. at 79 -80. Anesthetizing or sedating a subject is routine and
conventional. (See, e.g., Bibian 3-4 (generally describing the concept of
anesthesia).) Simultaneously monitoring the brain activity of the left and
right hemispheres of a subject under anesthesia using EEG electrodes is also
known in the art. Callahan, for instance, teaches that “EEG monitoring is
. . . recommended as a measure of an[e]sthetic depth” and further describes
as an object of its invention “to provide a brain wave monitoring device
which can simultaneously provide amplitude and frequency information
from both hemispheres of the brain in order to monitor unilateral hemisphere
brain dysfunction in real time.” (Callahan 1:36—43, 2:66—32; see also id. at
Abstract, 3:3—7 (“monitoring brain waves placed on the left and right
hemispheres of a patient’s head”), Bibian % 73 (describing use of a reference
electrode in EEG).)
Likewise, converting an EEG analog signal to a digital signal is
known in the art. (Bibian *[[73 (describing inputting EEG signal into an
analog/digital converter).) To the extent that it may be considered a
manipulative step rather than an abstract idea (e.g., an algorithm),
calculating a numerical QEEG index is also conventional activity already
engaged in by the scientific community. (Bibian Abstract (conducting “[a]
wavelet decomposition and statistical analysis of the observed EEG” and
comparing it to reference data to provide “a numerical indicator”); Spec.
4 Callahan et al., U.S. Patent No. 4,412,547, issued Nov. 1, 1983
(“Callahan”).
5 Bibian et al., US 2004/0010203 Al, published Jan. 15, 2004 (“Bibian”).
6 Sarkela et al., U.S. Patent No. 6,950,698 B2, issued Sept. 27, 2005
(“Sarkela”))
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20:6-7 (stating that the claimed QEEG indices “are calculated by using
variations of the transforms listed above or like techniques known ii
art”) (emphasis added).) Simultaneously displaying information from both
the left and right hemispheres of the brain on a monitor is similarly
conventional (See, e.g., Callahan 3:12—15 (describing “[a] brain wave
amplitude display having first and second linear arrays disposed side-by-side
[that] receive and display the brain wave amplitude information from the left
and right hemispheres respectively).)
Finally, the last two clauses of claim 21 simply requires comparing
the EEG indices from each hemisphere of the brain and determining whether
the differences between the indices from the two hemispheres indicate a
change in the status of the anesthetized subject. They simply tell the
intended audience of the natural law (i.e., the relationship between the
comparative brain activity between the two hemispheres and status of an
anesthetized subject) with the instruction to “apply it.”7
In short, when claim 21 is considered as an ordered combination, it
informs a relevant audience of certain laws of nature, with all of the
additional steps consisting of well-understood, routine, conventional activity
already engaged in by the scientific community.
Accordingly, we find that the Examiner has established a prirna facie
case that claim 21 is directed to patent-ineligible subject matter. We next
turn to Appellants’ arguments.
7 We note that Callahan suggests that this natural law is in fact already
known in the art as well. (Callahan 2:25—29 (explaining that “unilateral
hemisphere dysfunction . . . requires the comparison of one hemisphere to
the other”).)
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Appellants contend that the claimed subject matter “is not an abstract
idea but rather a very specific diagnostic and/or treatment protocol that was
unique at the time of invention,” (Appeal Br. 8; see also id, at 4.)
Appellants contend that,
[sjince . . . Appellants claim a “new and useful [diagnostic] process”
of calculating a QEEG time-series index corresponding to the brain or
cortical activity as a function of depth of anesthesia or sedation of
each of the left and right hemispheres of the subject’s brain tied to the
physical actions of real and particular machines and simultaneously
comparing these indices to identify changes in the subject's status,
their claims are patent-eligible under 35 U.S.C. § 101.
(Id. at 9.) Appellants contend that “[n]o other anesthesia or sedation
monitoring equipment at the time of the Appellants’ invention had [the]
capability” of allowing a clinician to “understand whether the subject is
encountering problems during anesthesia” by “examining the differences
between [the] indices [indicative of a subject’s cortical activity as a function
of depth of anesthesia of both hemispheres of a subject’s brain].” (Id. at 7.)
We are not persuaded. A diagnostic or treatment protocol that
“simply states the law of nature while adding the w?ords ‘apply it’” does not
“transform an unpatentable lav/ of nature into a patent-eligible application of
such a la w,” even if the natural law was not previously kno wn. Mayo, 566
U.S. at 72 (claims identifying correlations between certain metabolites and
effect of a thiopurine drug “with some precision” not patent eligible even
though “precise correlations between metabolite levels and likely harm or
ineffectiveness [of drug]” were not previously known to those in the field);
see also Ariosa, 788 F.3d at 1377 (finding the claims directed to patent
ineligible subject matter where the only new and useful subject matter was
the discovery of a natural phenomenon, i.e., the presence of cell-free fetal
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DNA in maternal plasma or serum); Ass 'n for Molecular Pathology v.
Myriad Genetics, Inc., 133 S.Ct. 2107, 2117 (2013) (explaining that
“[groundbreaking, innovative, or even brilliant discovery does not by itself
satisfy the § 101 inquiry”). Neither have Appellants persuasively shown that
the manipulative steps recited in the claims are anything more than
“con ventional steps, specified at a high level of generality,” appended to the
law of nature to which the claims are directed.8 Mayo, 566 U.S. at 82.
In the Reply Brief, Appellants contend that “[t]he prior art cortical
monitor . . . uses a QEEG index to determine the level of depth of anesthesia
based on the EEG of the whole brain or limited to EEG from one specific
hemisphere of the brain.” (Reply Br. 4.) Appellants further contend that the
claimed method provides certain advantages over the prior art “for solving
safety and efficacy problems with the current generation of cortical
monitors.” (Id.) We are not persuaded. As an initial matter, Appellants do
not address Callahan, which teaches monitoring the EEG of both
hemispheres of the brain. Furthermore, as already discussed, a claim that is
directed to an exception such as a law of nature or abstract idea without
more does not become patent eligible merely because it provides certain
advantages. Myriad, 133 S.Ct. at 2117.
Appellants also contend that the claims are patent eligible because
they require more than a generic computer structure and involve “one or
more particular machines,” including, e.g., machines and drugs for
8 For the same reason, we are not persuaded by Appellants’ argument in the
Reply Brief that the claims contain an “inventive concept” and are
“significantly more” than an abstract idea or natural law because the
Examiner did not find the claims obvious over the cited prior art (Callahan,
Bibian, and Sarkela). (Reply Br. 6.)
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anesthetizing a subject, “EEG electrodes for monitoring both the left and
right hemispheres of a subject’s brain,” electrical components or electronics
inherently required for “digitizing the analog signal from the EEG
electrodes,” a processor to “calculate^]... a separate index for each
hemisphere of the subject’s brain,” and a monitor for “displaying the indices
. . . simultaneously.” (Appeal Br. 9—11; see also id. at 13—14, Reply Br. 3—
4.) Appellants contend that such machines are “not generic . . . but rather
highly specific in order to improve on the current generation of cortical
monitors in the market.” (Reply Br. 3—4.) In addition, Appellants argue
that, even if these components are generic, “patentable inventions may
involve combinations of known elements” and “discovery of a new use of a
known . . . device . . . can ... be claimed as a method of use.” (Appeal Br.
13—14 (internal quotation marks and citation omitted).)
We are not persuaded. “[N]ot every claim that recites concrete,
tangible components escapes the reach of the abstract-idea inquiry.” In re
TLI Commc’ns LLC Patent Litig., 823 F.3d 607, 611 (Fed. Cir. 2016)
(finding a claim reciting “concrete, tangible components such as ‘a
telephone unit’ and a ‘server’” to nevertheless be directed to patent ineligible
subject matter). As also discussed further below with respect to the second
step of the Mayo analysis, here the “particular” machines referred to by
Appellants, e.g., the machines or drugs used for anesthetizing a subject, EEG
electrodes for monitoring brain activity, electrical components for digitizing
analog signals, processor, and monitor, are all conventional components in
the art. Mayo, 566 U.S. at 82 (“[Sjimply appending conventional steps,
specified at a high level of generality, to laws of nature, natural phenomena,
and abstract ideas cannot make those laws, phenomena, and ideas
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patentable.”). Likewise, while a patentable invention may involve a
combination of known elements or a new use of a known device, Appellants
have not persuaded us that the additional elements of claim 21 add
“significantly more” to the law of nature even when they are considered as
an ordered combination.
Appellants contend that the pending claims are similar to the claims
found to be patentable in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d
1245 (Fed. Cir. 2014), because, as in DDR Holdings, the claims on appeal
“solved a problem inherent in the base technology that did not exist absent
the base technology.” (Appeal Br. 12.) In particular, Appellants argue that
the claims on appeal “do not merely recite the performance of some business
practice use prior to the monitoring of depth of anesthesia or sedation”:
[T]he root problem of detecting, for example, neuro-
patholo[g]ical conditions during anesthesia or sedation, or of
effectively and safely providing the administration of anesthesia
or sedation was a problem that newly arose or became apparent
with the advent of monitoring for the depth of anesthesia or
sedation[,] and the solution proposed by the invention is novel
to both depth of anesthesia or sedation monitoring and therapy.
(Id.)
We are not persuaded. DDR Holdings involved claims that did “not
merely recite the performance of some business practice known from the
pre-Internet world along with the requirement to perform it on the Internet”
but rather provided a solution “necessarily rooted in computer technology in
order to overcome a problem specifically arising in the realm of computer
networks.” DDR Holdings, 773 F.3d at 1257. The DDR Holdings court
cautioned that “not all claims purporting to address Internet-centric
challenges are eligible for patent” and that the claims at issue in DDR
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Holdings are patentable because they “do not broadly and generically claim
‘use of the Internet’ to perform an abstract business practice (with
insignificantly added activity).” Id. at 1258.
Here, in contrast, claim 21 merely informs the intended audience of a
patent-ineligible law of nature (i.e., the relationship between the comparative
brain activity of the hemispheres of the brain and the status of a patient
under anesthesia) and then tells the audience to “apply it” using routine and
conventional steps and components. Mayo, 566 U.S. at 72.
For the same reasons, we are not persuaded by Appellants’ attempt to
analogize claim 21 to Diamond v. Diehr, 450 U.S. 175 (1981), which
Appellants contend held claims to be patentable where they “do not seek to
protect the use of [an] algorithm . . . except in conjunction with other steps
in the [claimed] process.” (Reply Br. 6—7.) Unlike the claims in Diehr,
which recites significantly more than simply the algorithm, claim 21 does
not recite significantly more than a law of nature.
Appellants additionally contend that the pending claims are patent
eligible because “the claimed invention does not preempt an entire field of
endeavor.” (Appeal Br. 14.) We are not persuaded. “While preemption
may signal patent ineligible subject matter, the absence of complete
preemption does not demonstrate patent eligibility.” Ariosa, 788 F.3d at
1379. To the contrary, as the Ariosa court explained, “[wjhere a patent’s
claims are deemed only to disclose patent ineligible subject matter under
the Mayo framework, . . ., preemption concerns are fully addressed and
made moot.” Id.
Finally, we acknowledge but are not persuaded by Appellants’
argument that the rejection should be reversed because the Examiner did not
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“back up the factual underpinnings of his analysis with an affidavit.” (Reply
Br. 5.) The Examiner has provided articulated reasoning to support the
prima facie case, including citing to case law and prior art. In contrast,
Appellants have not pointed to any particular factual underpinning for which
support is lacking.
For the reasons set forth above, we conclude that claim 21 is directed
to patent-ineligible subject matter. Claims 22—25, which are not separately
argued, fall with claim 21. 37 C.F.R. § 41.37(c)(l)(iv).
Claims 26-30. 32. and 34-40
Regarding claims 26—30, 32, and 34-40, Appellants argue that the
claims are directed to patentable subject matter because “[fjhese claims all
specifically invol ve the adjustment of therapy based on a comparison of . . .
[two quantitative EEG time-series indices]” and “inherently involv[e] a
substance and equipment possibly to administer the substance.” ( Appeal Br.
6: Reply Br. 3.)
We are not persuaded. Because Appellants argue 26-30, 32, and 34-
40 together, we limit our analysis to claim 26 as representative. 37 C.F.R.
§ 41.37(c)(l)(iv). Claim 26 depends from claim 21 and further comprises an
additional step of
treating the subject by administrating a drug or therapeutics to said
subject based on a comparison by a processor, clinician or physician
of at the least two quantitative electroencephalographic time-series
indices corresponding to the brain activity as a function of depth of
anesthesia or sedation of the brain region of the subject.
(Appeal Br. 18 (Claims App.).) This additional limitation, however, at most
suggests to the intended audience (e.g., doctors) that they should take into
account the correlation between comparative brain activity between the two
hemispheres of the brain and the status of the anesthetized patient in making
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any treatment decisions. The claim, for instance, does not recite any
particular drug or therapeutic that should be administered. In short, the
limitation merely describes “‘[p]ost-solution activity’ that is purely
‘conventional or obvious,’ [which] ‘can[not] transform an unpatentable
principle into a patentable process.’” Mayo, 566 U.S. at 82 (quoting Parker
v. Flook, 437 U.S. 584, 590 (1978)) (third bracket in original).
We therefore conclude that all of the claims on appeal are directed to
patent-ineligible subject matter.
SUMMARY
For the reasons above, we affirm the Examiner’s decision rejecting
claims 21—30, 32, and 34^40 under 35 U.S.C. § 101.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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