Court Opinion

ID: 3212878
Source: CourtListenerOpinion
Date Created: 2016-06-14 15:01:31.643815+00
Date Added: 2024-06-11T12:05:48.113804
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                ______________________

  IN RE: HANI KAYYALI, CRAIG A. FREDERICK,
   CHRISTIAN MARTIN, ROBERT N. SCHMIDT,
            BRIAN M. KOLKOWSKI,
                   Appellants
             ______________________

                      2016-1081
                ______________________

    Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. 11/811,156.
                  ______________________

                Decided: June 14, 2016
                ______________________

   BRIAN M. KOLKOWSKI, Flocel Inc., Cleveland, OH, for
appellants. Also represented by MARK PENNINGTON,
NeuroWave Systems Inc., Cleveland Heights, OH.

    THOMAS W. KRAUSE, Office of the Solicitor, United
States Patent and Trademark Office, Alexandria, VA, for
appellee Michelle K. Lee. Also represented by BENJAMIN
T. HICKMAN, FRANCES LYNCH.
                 ______________________

 Before TARANTO, CLEVENGER, and CHEN, Circuit Judges.
PER CURIAM.
2                                            IN RE: KAYYALI

    Hani Kayyali, Craig A. Frederick, Christian Martin,
Robert N. Schmidt, and Brian M. Kolkowski (collectively,
Kayyali) filed an application for a patent on methods of
conducting an at-home sleep analysis. As relevant here,
an examiner rejected Kayyali’s claims for obviousness
based on the prior-art reference Westbrook, either alone
or in combination with another prior-art reference, Fey.
The Patent Trial and Appeal Board affirmed.
    Kayyali appeals, arguing that an ordinarily skilled ar-
tisan would not have been motivated to modify West-
brook, that Westbrook actually teaches away from the
modification, that Fey is not analogous art, and that an
ordinarily skilled artisan would not have been motivated
to combine Westbrook and Fey. We reject those argu-
ments and therefore affirm.
                      BACKGROUND
     Kayyali’s patent application describes “a method of
conducting a sleep analysis by collecting physiologic and
kinetic data from a subject, preferably via a wireless in-
home data acquisition system, while the subject attempts
to sleep at home.” J.A. 69. The in-home sleep test “pro-
vides more accurate data for the sleep diagnosis” than
would a sleep test conducted in a laboratory, subjects
being “generally more comfortable sleeping at home.” J.A.
73. Kayyali describes applying at least two sensors to the
subject to collect physiological, kinetic, or environmental
signals. For example, electrodes may be placed on the
subject’s scalp to measure brain waves or on the subject’s
torso to measure electrical currents generated by the
heart. The application also calls for a pulse oximeter to
measure respiration and oxygenation of the subject’s
blood. The various sensors are connected to a data acqui-
sition system, which is preferably light-weight, easily
transported, and capable of collecting and transmitting
data from the sensors. Sleep-test data is transmitted,
IN RE: KAYYALI                                             3

preferably in real time, to allow for a sleep-trained techni-
cian to monitor and analyze the test results remotely.
    Pending claims 1–7 and 34–47 are at issue in this ap-
peal. Claims 1 and 7 are illustrative for present purposes:
     1. A method of conducting an at-home sleep
    analysis comprising the steps of:
     applying at least two sensors and a pulse oxime-
      ter to a subject,
     connecting the at least two sensors and the
       pulse oximeter before or after application to
       the subject to a data acquisition system includ-
       ing a patient interface box with wireless radio
       frequency transmission capability, the patient
       interface box being capable of receiving signals
       from the at least two sensors and the pulse ox-
       imeter, digitizing the signals, and retransmit-
       ting the digitized signals, or transmitting
       another digitized signal based at least in part
       on at least one of the sensor signals by bidirec-
       tional wireless radio frequency transmission,
     collecting and digitizing the signals from the at
       least two sensors and the pulse oximeter ap-
       plied to the subject while the subject is sleep-
       ing at home with the patient interface box,
     transmitting the digitized signals or transmit-
       ting the other digitized signal based at least in
       part on the sensor signals to a remote location,
       at least in part by wirelessly transmitting the
       digitized signals utilizing a bidirectional radio
       frequency signal transmission, and
     analyzing the retransmitted digitized signals or
      the transmitted other digitized signal by a
      sleep trained individual to diagnose whether
      the subject has a sleeping disorder.
4                                              IN RE: KAYYALI

J.A. 4.
      7. The method in claim 1, including the further
    steps of having the subject visit a physician’s or
    clinician’s office or place of business;
      providing the subject at the physician’s or clini-
       cian’s office or place of business with the port-
       able patient interface and three sensors;
      providing the subject or the subject’s care pro-
       vider with direct face-to[-]face demonstration
       with instruction and guidance regarding use
       and application of the portable patient inter-
       face box and the three sensors;
      sending the subject home or to another location
        remote from the physician’s or clinician’s office
        or place of business with the portable patient
        interface box and the three sensors and having
        the subject or the subject’s care provider use
        the instruction and guidance to apply and con-
        nect the sensors and to use the patient inter-
        face box;
      analyzing the transmitted data at a location re-
       mote from both the physician’s or clinician’s of-
       fice or place of business and the subject’s home
       or other remote location to make the diagnosis
       of whether the subject has the sleep disorder;
      sending the diagnosis of the collected data to the
        physician or clinician;
      and determining a treatment if required for the
       subject.
J.A. 5. Claim 38 further requires the subject to “return
the portable patient interface box and the sensors . . .
after the data is collected.” J.A. 7.
IN RE: KAYYALI                                             5

    The examiner rejected claims 1–7 and 34–47 for obvi-
ousness: claims 1–3, 6, 34, and 41 over Westbrook; claim 4
over Westbrook in view of Thompson; claim 5 over West-
brook in view of Auphan; and claims 7, 35–40, and 42–47
over Westbrook in view of Fey. Only Westbrook and Fey
are now pertinent, because Kayyali has not independently
challenged the rejection of claims 4 and 5.
     U.S. Patent Application Publication No. 2005/0027207
to Westbrook et al. describes a monitoring system for
collecting and analyzing physiological signals to detect
sleep apnea. The system includes a small, light-weight
device that is attached to the subject’s forehead and
contains several sensors, including a pulse oximeter. The
system collects data, which “may be directly transmitted
to an offsite facility for processing and report generation.”
Westbrook, ¶ 78. Although Westbrook recognizes that
“[t]he current ‘gold standard’ for the diagnosis of [sleep
apnea] is an . . . overnight sleep study . . . administered
and analyzed by a trained technician,” id. ¶ 8, the de-
scribed system automatically generates a report based on
the sleep data that can include “a full-disclosure presenta-
tion of the physiological recordings from the entire ses-
sion” for physicians to analyze, id. ¶ 156.
    U.S. Patent Application Publication No. 2007/0143151
to Fey et al. describes a system to manage and analyze
electronic medical records. After undergoing medical
testing, a patient receives a smart drive that contains test
results and other information. The patient can plug the
smart drive into her computer to input data and to inter-
act with data already stored on the device. “[T]he user-
inputted information can be transmitted to the central-
ized system and one or more health care professionals for
evaluation and feedback,” allowing health plans to be
revised and updated. Fey, ¶ 40.
    Kayyali appealed the rejection of claims 1–7 and 34–
47 to the Board. Kayyali argued that the examiner did
6                                            IN RE: KAYYALI

not identify any motivation a relevant skilled artisan
would have had to modify Westbrook to have a remotely
located sleep-trained technician analyze sleep data and
that Westbrook teaches away from using a sleep-trained
individual altogether. Kayyali further argued that Fey is
not analogous art because, contrary to the examiner’s
finding, it does not describe an “ambulatory physiological
monitor.”
    The Board affirmed the examiner’s rejection of claims
1–7 and 34–47. The Board adopted the factual findings
and analysis of the examiner’s answer, which concluded
that “[i]t would have been obvious to one of ordinary skill
in the art to substitute one known method for another to
achieve the expected results of diagnosing sleep disorders,
such as using a board-certified clinician to analyze col-
lected data as taught by Westbrook in place of the com-
puterized analysis used in the invention of Westbrook.”
J.A. 619. In denying Kayyali’s request for rehearing, the
Board elaborated: “it was well known at the time of the
invention to use sleep trained individuals to review sleep
data and additionally well known that sleep data could be
forwarded to a remote location in view of Westbrook, to
have sleep trained individuals to review sleep data at a
remote location.” J.A. 688–89.
    Kayyali appealed to this court, and because the Board
did not address Kayyali’s arguments regarding Fey, this
court granted the Director’s motion to remand the case for
further proceedings. On remand, the Board again af-
firmed the examiner’s rejection of claims 1–7 and 34–47.
The Board repeated its analysis that it would have been
obvious to use a sleep-trained individual to analyze the
sleep data generated in Westbrook. With respect to Fey,
the Board explained that Fey shows “the well-known
rudimentary business practice of examining a patient in a
medical center, providing the patient with a medical
recording device, returning home to use the device, and
returning the device to the physician.” J.A. 24. The
IN RE: KAYYALI                                            7

Board found that Fey is both within the field of the inven-
tor’s endeavor—“ambulatory physiological monitoring”—
and reasonably pertinent to solving the inventor’s prob-
lem.
    Kayyali appeals under 35 U.S.C. § 141(a), challenging
the Board’s rejection of claims 1–7 and 34–47 for obvious-
ness.      We have jurisdiction under 28 U.S.C.
§ 1295(a)(4)(A).
                       DISCUSSION
    We review the Board’s ultimate determinations of ob-
viousness de novo. Randall Mfg. v. Rea, 733 F.3d 1355,
1362 (Fed. Cir. 2013). Underlying factual findings, in-
cluding findings as to whether a reference is analogous
art and the presence or absence of a motivation to com-
bine or modify with a reasonable expectation of success,
are reviewed for substantial evidence. Id.; In re Bigio,
381 F.3d 1320, 1324 (Fed. Cir. 2004).
    Kayyali first challenges the Board’s rejection of claims
1–3, 6, 34, and 41 for obviousness over Westbrook; in so
doing, Kayyali treats claim 1 as representative. Kayyali
argues that a relevant skilled artisan would not have
been motivated to modify the computer-automated analy-
sis described in Westbrook to allow a sleep-trained indi-
vidual to perform the diagnosis. But Westbrook explicitly
states that diagnosis by a sleep-trained clinician is the
current “gold standard,” thus confirming that a skilled
artisan would have a motivation to replace computer-
automated diagnosis with diagnosis by a specialist (at
least some of the time) to achieve better diagnosis of the
patient.
    Kayyali also argues that Westbrook teaches away
from the modification because it disparages the use of a
sleep-trained individual. Westbrook suggests that an
overnight sleep study conducted by a sleep-trained clini-
cian is expensive and that detection can vary by clinician
8                                           IN RE: KAYYALI

because professional organizations have provided limited
guidelines. At most, those suggestions indicate some
advantages for computer analysis that may make such
analysis preferable in many circumstances. That is not
enough to teach skilled artisans away from the alterna-
tive that Westbrook identifies and calls the “gold stand-
ard.” See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir.
2004); DePuy Spine, Inc. v. Medtronic Sofamor Danek,
Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009). The Board,
therefore, did not err in finding that Westbrook does not
teach away from using sleep-trained individuals.
    In addition, Kayyali challenges the Board’s rejection
of claims 7, 35–40, and 42–47 on the ground that Fey is
not analogous art; in so doing, Kayyali treats claim 7 as
representative. To be analogous art, a prior-art reference
must (1) be reasonably pertinent to the particular prob-
lem with which the inventor is involved or (2) be from the
same field of endeavor. See Innovention Toys, LLC v.
MGA Entm’t, Inc., 637 F.3d 1314, 1321 (Fed. Cir. 2011).
The Board found that Fey qualifies under both of the
alternatives. Kayyali argues that Fey qualifies under
neither.
    The Board properly found that Fey is reasonably per-
tinent to the problem at hand, as “Fey would logically
have commended itself to an inventor’s attention in
considering the problem of medical device portability,
data transfer and ambulatory physiological monitoring.”
J.A. 26. Fey discloses a device that the patient can take
home to “input and manage information pertaining to one
or more health/intervention plans” and that can “include
a plan revision component for updating the one or more
health plans based upon the user-inputted information.”
Fey, ¶ 40. The device allows both the patient and physi-
cian to observe and review the patient’s physiological
health data. Therefore, as the Board found, Fey is rea-
sonably pertinent to the problem faced by Kayyali—
providing a patient with a medical device, sending the
IN RE: KAYYALI                                           9

device home for the patient to use, and returning the
device after use. Because substantial evidence supports
the Board’s finding that Fey is reasonably pertinent to the
particular problem of the claimed invention, and therefore
analogous art, we need not reach Kayyali’s argument that
Fey is not in the same field of endeavor.
    Finally, Kayyali contends that a relevant skilled arti-
san would not have been motivated to combine the in-
home sleep-test device of Westbrook with the teachings of
Fey. The Board found that “Fey solves the known prob-
lem of providing patient care using an ambulatory medi-
cal device by giving the patient the portable device in
person, and sending [the patient] home to use the device,
and later returning the device.” J.A. 29. The Board
determined that Fey’s method itself provides a motivation
to combine Fey with Westbrook—to achieve the benefits
of “providing patient care using an ambulatory medical
device.” J.A. 27. The Board did not err in reaching this
conclusion.
                       CONCLUSION
    For the foregoing reasons, we affirm the Board’s rejec-
tion of the claims at issue.
                      AFFIRMED