Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-16-01081/USCOURTS-ca13-16-01081-0/pdf.json

Parties Involved:
Craig A. Frederick
Appellant
Hani Kayyali
Appellant
Brian M. Kolkowski
Appellant
Christian Martin
Appellant
Robert N. Schmidt
Appellant

Document Text:

NOTE: This disposition is nonprecedential.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. 

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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 artisan would not have been motivated to modify Westbrook, 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 arguments 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 inhome data acquisition system, while the subject attempts 

to sleep at home.” J.A. 69. The in-home sleep test “provides 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 acquisition system, which is preferably light-weight, easily 

transported, and capable of collecting and transmitting 

data from the sensors. Sleep-test data is transmitted, 

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IN RE: KAYYALI 3

preferably in real time, to allow for a sleep-trained technician to monitor and analyze the test results remotely. 

Pending claims 1–7 and 34–47 are at issue in this appeal. 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 oximeter 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 including 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 oximeter, digitizing the signals, and retransmitting the digitized signals, or transmitting 

another digitized signal based at least in part 

on at least one of the sensor signals by bidirectional wireless radio frequency transmission,

collecting and digitizing the signals from the at 

least two sensors and the pulse oximeter applied to the subject while the subject is sleeping at home with the patient interface box,

transmitting the digitized signals or transmitting 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.

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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 clinician’s office or place of business with the portable patient interface and three sensors;

providing the subject or the subject’s care provider with direct face-to[-]face demonstration 

with instruction and guidance regarding use 

and application of the portable patient interface 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 connect the sensors and to use the patient interface box;

analyzing the transmitted data at a location remote from both the physician’s or clinician’s office 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.

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The examiner rejected claims 1–7 and 34–47 for obviousness: claims 1–3, 6, 34, and 41 over Westbrook; claim 4 

over Westbrook in view of Thompson; claim 5 over Westbrook 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 described system automatically generates a report based on 

the sleep data that can include “a full-disclosure presentation of the physiological recordings from the entire session” 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 interact with data already stored on the device. “[T]he userinputted information can be transmitted to the centralized 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 

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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 collected data as taught by Westbrook in place of the computerized 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 affirmed 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 

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IN RE: KAYYALI 7

Board found that Fey is both within the field of the inventor’s endeavor—“ambulatory physiological monitoring”—

and reasonably pertinent to solving the inventor’s problem. 

Kayyali appeals under 35 U.S.C. § 141(a), challenging 

the Board’s rejection of claims 1–7 and 34–47 for obviousness. We have jurisdiction under 28 U.S.C. 

§ 1295(a)(4)(A).

DISCUSSION

We review the Board’s ultimate determinations of obviousness de novo. Randall Mfg. v. Rea, 733 F.3d 1355, 

1362 (Fed. Cir. 2013). Underlying factual findings, including findings as to whether a reference is analogous 

art and the presence or absence of a motivation to combine 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 analysis described in Westbrook to allow a sleep-trained individual 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 computerautomated 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 clinician is expensive and that detection can vary by clinician 

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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 alternative that Westbrook identifies and calls the “gold standard.” 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 problem 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 pertinent 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 physician to observe and review the patient’s physiological 

health data. Therefore, as the Board found, Fey is reasonably pertinent to the problem faced by Kayyali—

providing a patient with a medical device, sending the 

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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 artisan would not have been motivated to combine the inhome sleep-test device of Westbrook with the teachings of

Fey. The Board found that “Fey solves the known problem of providing patient care using an ambulatory medical 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 rejection of the claims at issue.

AFFIRMED

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