before the patent trial and appeal board ex parte rani … · 15/10/2015 · on may 15, 2015, the...

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

Ex parte RANI KA YY ALI, CRAIG A. FREDERICK, CHRISTIAN MARTIN, ROBERT N. SCHMIDT, and

BRIAN M. KOLKOWSKI

Appeal2012-010660 Application 11/811, 156 Technology Center 3700

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and CHRISTOPHER G. P AULRAJ, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON REMAND

On May 15, 2015, the Federal Circuit remanded its docket no. 2015-

1268, for the above appeal for further proceedings. The case was remanded

with the order and instruction that the Board complete its reconsideration and

issue an appealable decision no later than 90 days after the date of this order

(i.e., August 13, 2015).

In response, we substitute this Decision on Remand, which is

consistent with our original decision, for our Decision dated August 26, 2014.

Case: 16-1081 Document: 1-3 Page: 9 Filed: 10/15/2015 (14 of 58)

Appeal2012-010660 Application 11/811, 156

STATEMENT OF CASE

Claims 1-7 and 21--47 are pending. Claims 21-33 are withdrawn from

consideration. Claims 1-7 and 34--47 are rejected. We have jurisdiction

under 35 U.S.C. § 6(b ).

The following claims are representative (as amended March 21, 2011).

Due to the dispute in the record as to which claims are pending, we reproduce

all claims set forth in the March 21, 2011 Amendment, that have not been

withdrawn from prosecution.

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.

2. The method in claim 1, further including a step of checking the signals from the sensors for signal quality until the signals are adequate for later analysis.

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3. The method in claim 1, wherein one of the at least two sensors is a nasal cannula and the patient interface box for receiving and transmitting signals further comprises a pressure transducer integral to the patient interface box for estimating airflow during inspiration and expiration by the subject.

4. The method in claim 1, wherein the transmitted or retransmitted digitized signals are all encrypted to protect the subject's patient health information.

5. The method in claim 1, further including at least one environmental sensor used to collect data, the environmental sensor being a photodetector, a light meter, a thermal sensor, a particle detector, a chemical sensor, a mold sensor, an olfactory sensor, a barometer, or a hygrometer.

6. The method in claim 1, wherein the at least two sensors are being used to measure airflow of the subject, and respiratory effort of the subject.

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.

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34. A method of conducting an improved at-home sleep analysis comprising the steps of:

applying at least three sensors to a subject including a respiratory belt, a nasal airflow sensor and a pulse oximeter,

connecting the at least three sensors to a portable patient interface box, the patient interface box comprising either wireless bi-directional radio frequency transmission capability and/or a nonvolatile digital memory, the patient interface box further comprising sensor inputs used to connect the at least three sensors to the portable patient interface box,

collecting and digitizing the signals from the at least three sensors 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, and

analyzing the re-transmitted digitized signals or the transmitted other digitized signal by a sleep trained individual to diagnose whether the subject has a sleeping disorder.

35. The method in claim 34, 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 a direct face

to-face demonstration with instruction and guidance regarding the use and application of the portable patient interface box and the three sensors; and

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 thee [sic] 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.

36. The method of conducting an improved at-home sleep analysis in

claim 35, including the further steps of: analyzing the transmitted data at a location remote from both the

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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 analysis of the collected data to the physician or clinician; and determining a treatment if required for the subject.

37. The method in claim 36, further including a step of checking the signals from the respiratory belt, the nasal airflow sensor and the pulse oximeter for signal quality until the signals are adequate for later analysis at the subject's home or the other location remote from the physician's or clinician's office or place of business.

38. The method in claim 36, further including the step of having the subject return the portable patient interface box and the sensors to the physician's or clinician's office or place of business after the data is collected wherein the data is then transmitted to the sleep trained individual at a location remote from the physician's or clinician's office or place of business.

39. The method in claim 36, wherein the nonvolatile digital memory is a removable card with an upper or lower surface having a surface area of less than 2 square inches.

40. The method in claim 36, wherein the patient interface box further comprises a signal processing module, the signal processing module further comprising an input( s) for receiving the signal, an analog to digital converter for digitizing the signal, a micro controller with signal processing capability and programming for artifact removal, and a connection to the non-volatile digital memory.

41. A method of conducting an improved at-home sleep analysis comprising the steps of:

applying at least three sensors to a subject including a pulse oximeter, a photodetector for measuring the subject's physiological condition including heart rate, and a kinetic sensor for measuring the subject's body movement,

connecting the at least three sensors to a portable patient interface box, the patient interface box comprising either wireless bi-directional radio frequency transmission capability and/or a non-volatile digital memory, the

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patient interface box further comprising sensor inputs used to connect the at least thee [sic] sensors to the portable patient interface box,

collecting and digitizing the signals from the at least three sensors applied to the subject while the subject is sleeping at home with the patient interface box,

transmitting the digitized signals or transmitting another digitized signal based at least in part on the sensor signals to a remote location, 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.

42. The method in claim 41, 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; and

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.

43. The method of conducting an improved at-home sleep analysis in claim 42, including the further steps of:

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 another remote location to make the diagnosis of whether the subject has the sleep disorder;

sending the analysis of the collected data to the physician or clinician; and determining a treatment if required for the subject.

44. The method in claim 43, further including a step of checking the signals from the respiratory belt, the nasal airflow sensor and the pulse oximeter for signal quality until the signals are adequate for later analysis at

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the subject's home or the other location remote from the physician's or clinician's office or place of business.

45. The method in claim 43, further including the step of having the subject return the portable patient interface box and the sensors to the physician's or clinician's office or place of business after the data is collected wherein the data is then transferred to the sleep trained individual at a location remote from the physician's or clinician's office or place of business.

46. The method in claim 43, wherein the nonvolatile digital memory is a removable card with an upper or lower surface having a surface area of less than 2 square inches.

47. The method in claim 43, wherein the patient interface box further comprises a signal processing module, the signal processing module further comprising an input( s) for receiving the signal, an analog to digital converter for digitizing the signal, a micro controller with signal processing capability and programming for artifact removal, and a connection to the non-volatile digital memory.

Cited References

Thompson US 2001/0027331 Al Westbrook et al. US 2005/0027207 Al (hereinafter "Westbrook") Auphan US 2005/0143617 Al Fey et al. US 2007/0143151 Al (hereinafter "Fey")

Grounds of Rejection

Oct. 4, 2001 Feb. 3,2005

June 30, 2005 June 21, 2007

I. Claims 1-3, 6, 34, and 41 are rejected under 35 U.S.C. § 103(a) as

being unpatentable over Westbrook.

II. Claim 4 is rejected under 35 U.S.C. § 103(a) as being

unpatentable over Westbrook in view of Thompson.

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III. Claim 5 is rejected under 35 U.S.C. § 103(a) as being

unpatentable over Westbrook in view of Auphan.

IV. Claims 7, 35--40, and 42--47 are rejected under 35 U.S.C.

§ 103(a) as being unpatentable over Westbrook in view of Fey.

FINDINGS OF FACT

The Examiner's findings of fact are set forth in the Answer at pages

5-14.

PRINCIPLES OF LAW

In making our determination, we apply the preponderance of the

evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427

(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings

before the Office). The Board "determines the scope of claims in patent

applications not solely on the basis of the claim language, but upon giving

claims their broadest reasonable construction 'in light of the specification as

it would be interpreted by one of ordinary skill in the art."' Phillips v. AWH

Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (quoting In re Am. Acad. of Sci.

Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).

"In rejecting claims under 35 U.S.C. § 103, the examiner bears the

initial burden of presenting a prima facie case of obviousness. Only if that

burden is met, does the burden of coming forward with evidence or

argument shift to the applicant." In re Rijckaert, 9 F.3d 1531, 1532 (Fed.

Cir. 1993) (citations omitted). In order to determine whether a prima facie

case of obviousness has been established, we consider the factors set forth in

Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content

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of the prior art; (2) the differences between the prior art and the claims at

issue; (3) the level of ordinary skill in the relevant art; and ( 4) objective

evidence of nonobviousness, if present.

"The combination of familiar elements according to known methods

is likely to be obvious when it does no more than yield predictable results."

KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).

As to motivation to combine, the Supreme Court in KSR, 550 U.S. at

415, rejected a rigid application of the teaching-suggestion-motivation test.

The Court recognized that it is often necessary to look at the interrelated

teaches of multiple references; the effects of demands of the marketplace;

and the background knowledge possessed by a person of ordinary skill, "all

in order to determine whether there was an apparent reason to combine the

known elements in the fashion claimed." Id. at 418. Moreover, the

"obviousness analysis cannot be confined by a formalistic conception of the

words teaching, suggestion, and motivation, or by overemphasis on the

importance of published articles and explicit content of issued patents." Id.

at 419.

Moreover,

When 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 known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.

Id. at 421.

The test for non-analogous art is first whether the art is within the

field of the inventor's endeavor and, if not, whether it is "reasonably

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pertinent to the particular problem with which the inventor was involved."

In re Wood, 599 F.2d 1032, 1036 (CCPA 1979). "A reference is reasonably

pertinent if, even though it may be in a different field" of endeavor, it

logically would have commended itself to an inventor's attention in

considering his problem "because of the matter with which it deals." In re

Clay, 966 F.2d 656, 659 (Fed. Cir. 1992). Cf Wyers v. Master Lock Co.,

616 F.3d 1231, 1238 (Fed. Cir. 2010) (the scope of analogous art should be

construed broadly).

Pending Claims

The Examiner indicates that

The claims appendix [to the Brief] contains errors. Specifically, Applicant[ s] has attached the amended claims as filed January 12, 2012. These amendments were not entered, as noted in the advisory action mailed March 19, 2012, since they require further search and consideration. As such, claims 6, 40, and 44, marked "rejected" in the claims appendix, have in fact not been rejected. Claims 6, 40, and 44 as filed March 21, 2011 are those which were rejected prior to this appeal.

(Ans. 4.)

Appellants contend that their Amendment filed January 12, 2012

should have been entered as of right. (Reply Br. 2.)

The Examiner's refusal to enter the amendment at issue is a

petitionable matter under 3 7 C.F .R. § 1.181 and not within the jurisdiction of

the Board. 37 C.F.R. § 1.127; In re Berger, 279 F.3d 975, 984 (Fed. Cir.

2002) (citing In re Hengehold, 440 F.2d 1395, 1403 (CCPA 1971)). Thus,

we treat the pending claims as those filed March 21, 2011, reproduced

above.

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Rejection I

I. Claims 1-3, 6, 34, and 41 are rejected under 35 U.S.C. § 103(a) as

being unpatentable over Westbrook.

ISSUE

The Examiner contends that

Westbrook states in paragraphs 0135, 0137, and 0152-0155 analyzing collected data to determine the presence of sleeping disorders. The invention of Westbrook uses computer analysis, however Westbrook states that sleep certified clinician analysis is known and "current practice" (Westbrook paragraph 0008, 0137). It 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. Although Westbrook states that clinician analysis could provide varying decisions, Westbrook discloses both analys[ e] s as known methods. Furthermore, Applicant has not disclosed any advantages or necessities of using a sleep-trained individual as opposed to computerized analysis, and page 38 of Applicant's specification discloses using sleep-trained individuals or computerized analysis in the alternative.

(Ans. 7.)

Appellants argue that,

Westbrook is silent as to the use of a sleep trained individual located at a remote location to provide an analysis of a subject's sleep test data as is required by the language of claim 1. Westbrook further explicitly states that use of a sleep trained individual to perform analysis is undesirable because, according to Westbrook, "[d]etection of the important changes in the signals can vary by clinician and only limited guidelines have

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been provided by professional organizations." Westbrook, [0137].

(App. Br. 7.)

Appellants contend that Westbrook does not disclose bi-directional

communication consistent with its use in the Specification. (App. Br. 6.)

Appellants argue that

the Examiner asserted that Westbrook discloses a patient interface box capable of bi-directional wireless radio frequency transmission, as well as the step of transmitting signals through the use of bi-directional radio frequency signal transmission. In asserting that bi-directional data transmission is disclosed by Westbrook, the Examiner stated that "the wireless interface [of Westbrook] is used to upload and download data and is thus b-idirectional." Office Action, 10/12/2011, page 4. However, in making this statement the Examiner failed to take into account the disclosure in the Appellants' specification regarding bi-directional data transmission. Specifically, the Appellants describe bi-directional data transmission in their specification as the process through which data can be redundantly transmitted to ensure data integrity. See Specification, page 27, line 2 -page 28, line 22.

(App. Br. 6.)

The issue is: Does the cited prior art support the Examiner's finding

that the claimed subject matter is obvious?

I. ANALYSIS

We agree with the Examiner's fact finding, statement of the rejection

and responses to Appellants' arguments as set forth in the Answer. We find

that the Examiner has provided evidence to support a prima facie case of

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obviousness for most of the pending claims, with exceptions indicated

below. We provide the following additional comments.

We agree with the Examiner that an "offsite" facility is a remote

location consistent with the pending claims, and that "uploading and

downloading data" constitutes "bidirectional communication" consistent

with the pending claims. (Westbrook 7 i-f 78; Ans. 15.) We decline to read

limitations from the specification into the claims, a practice that the Court of

Appeals for the Federal Circuit, our reviewing court, cautions against. See

In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (Although the claims

are interpreted in light of the specification, "claims are to be given their

broadest reasonable interpretations" and "limitations are not to be read into

the claims from the specification."). Therefore, if Appellants intended to

claim a specific form of bi-directional communication, Appellants are in the

best position to clarify the claim meaning. No specific requirement is

present in claim 1 for redundant transmission of the bi-directional data as

argued by Appellants (App. Br. 6). "An essential purpose of patent

examination is to fashion claims that are precise, clear, correct, and

unambiguous. Only in this way can uncertainties of claim scope be

removed, as much as possible, during the administrative process." In re

Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989).

Claims 1, 2, 34, and 36

Appellants argue that the, "Examiner failed to take into account the

disclosure in the Appellants' specification regarding bi-directional data

transmission." (App. Br. 6.)

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As indicated above, we agree with the Examiner's claim interpretation

of "bi-directional wireless radio frequency transmission" and agree with the

Examiner's reasoning in the statement of rejection. Westbrook, page 7 i-f 78,

discloses that "data may be directly transmitted to an offsite facility for

processing and report generation."

Westbrook further discloses that it is a well-known practice for "a

clinician board-certified in sleep medicine ... to visually recognize patterns

across the various signals in order to differentiate obstructive-related

respiratory events from the other types." (Westbrook 11,-r137.) Westbrook

,-r 164 discloses that treatment efficacy is determined by a physician. (Ans.

11.) Therefore, we agree with the Examiner (Ans. 7) that one of ordinary

skill in the art familiar with Westbrook would have found it obvious to send

sleep data to an offsite facility for processing and report generation. In

addition, because it is well known in the art from Westbrook for a clinician

board-certified in sleep medicine to visually recognize patterns across the

various signals in order to differentiate obstructive-related respiratory events

from the other types, it would have been obvious to use a sleep trained

individual to analyze, prepare and generate a Westbrook's report of sleep

data at an offsite facility or analyze the retransmitted digitized signals by a

sleep trained individual.

Similar arguments are presented by Appellants for claims 2 (App. Br.

8-9) and 34 (App. Br. 10.) The rejection of claims 1, 2, 34, and 36 is

affirmed for the reasons of record.

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Claim 3


With respect to claim 3, the Examiner asserted that Westbrook discloses a "nasal cannula connected to the monitoring device, which is used to measure nasal pressure and airflow." Office Action, 10/12/2011, page 5. However, a closer reading of claim 3 shows that claim 3 requires that the patient interface box include a "pressure transducer integral to the patient interface box for estimating airflow during inspiration and expiration by the subject." Significantly, Westbrook does not explicitly discuss a pressure transducer being used with its device to measure airflow, much less a pressure transducer integral to the device disclosed therein as a means of measuring airflow.

(App. Br. 9.)

The Examiner finds that Westbrook discloses in paragraphs i-fi-f 134--

136 and figure 16 a nasal cannula connected to the monitoring device, which

is used to measure nasal pressure and air flow. (Ans. 7.) We find that the

Examiner has the better argument. The Examiner's rejection is supported by

Westbrook 1 i-f 14 which teaches a "simple nasal cannula attached to a

pressure transducer", and the rejection of claim 3 is affirmed. [Emphasis

added.] (See also Westbrook i-fi-f 134--136; Ans. 7, 16.)

Claim 6

Pending claim 6 recites sensors to measure airflow and respiratory

effort, and not the use of a fingertip pulse oximeter. Appellants argue that

Claim 6 requires the use of "a fingertip pulse oximeter." "Significantly,

Westbrook is silent as to the use of a fingertip pulse oximeter in combination

with the device disclosed therein." (App. Br. 9-10.) We agree with the

Examiner's statement of the rejection of claim 6 on page 16 of the Answer

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that the claim 6 subject matter Appellants argue is not of record. Appellants

present no argument on the merits to pending claim 6. Therefore, claim 6 is

affirmed for the reasons of record.

Claim 41

Appellants argue on page 11 of the Brief that, while Westbrook does

disclose a pulse oximeter that utilizes a photodetector (see, e.g., Westbrook

i-f 102), Westbrook is silent as to the use of an additional independent

"photodetector for measuring the subject's physiological condition including

heart rate" as required by claim 41.

The Examiner finds that "Claim 41 is rejected on substantially the

same basis as claims 1 and 34 above, further where Westbrook discloses

pulse rate and blood oxygen sensors which utilize photodetectors and

accelerometers in paragraphs 0058, 0061, 0066, 0071, 0135, 0140." (Ans.

10.) The Examiner argues that

Regarding claim 41, Westbrook discloses multiple photodetectors (light absorption sensors) used to measure pulse rate and blood oxygen, both of which provide heart rate. The Examiner further notes that claim 41 recites "a photodetector for measuring ... heart rate," where the measurement of heart rate is the intended use of the photodetector. The photodetector of Westbrook is capable of measuring heart rate, is it does by measuring pulse rate, and therefore meets the claim.

(Id. at 16.)

We agree that the Examiner has put forth a prima facie case of

obviousness for claim 41. In particular, the Westbrook Abstract states, in

addition to the passages cited by the Examiner, that, "[t]he physiological

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monitoring system may contain several sensors including a pulse oximeter to

detect oximetry and pulse rate, a microphone to detect snoring sounds, and a

position sensor to detect head position." (See also Westbrook 2 i-f 21.)

Appellants have failed to provide evidence that the pulse oximetry

light sensor of Westbrook does not measure heart rate with a light sensor

(photodetector). The rejection of claim 41 is affirmed.

Claim 5

We have reviewed Appellants' arguments regarding the rejection of

claim 5 on pages 16 and 17 of the Brief, however, we agree with the

Examiner's statement of the rejection on pages 10-11 of the Answer, and do

not find that Appellants have rebutted the Examiner's prima facie case with

respect to claim 5, by a preponderance of the evidence.

Furthermore, Auphan, page 2 i-f 20, discloses that, "[b ]uilt in sensors

and feedback loops in the system monitor a person's body and environment

and then use sophisticated computer implemented data analysis routines to

modify the environment and improve the person's sleep." "Sensor inputs

recording vital signs of a person during sleep are combined with

environmental sensor information to provide a context or baseline for the

person's sleep analysis." Id. at i-f 21. Therefore, the sleep sensors worn by

the individual in Auphan record how the individual reacts to environmental

stimulus and how this stimulus affects an individual's sleep. We agree with

the Examiner that

It would have been obvious to one of ordinary skill in the art at the time of invention to modify the monitoring system of Westbrook to include the environmental sensors of Auhpan [sic], since Auphan teaches environmental data as useful in

17



monitoring sleep quality and assessing sleep disorders (Auphan paragraphs 0008, 0021, 0032, 0049, 0054).

(Ans. 11.) Appellants provide no evidence in rebuttal. We affirm the

rejection of claim 5 for the reasons of record.

Claim 39

Appellants argue in the Reply Br., page 4, that, "[ s ]pecifically,

nothing in the Examiner's current or past statements indicates that, as of

August 25, 2004 (the date of filing of the Westbrook reference), 'flash cards

[were] industry standard removable memory cards having dimensions of

approx. 1 inch x 1 inch.'"

We agree with the Examiner that, "Westbrook discloses multi-media

flash cards in at least paragraph 0058." (Ans. 19.) Moreover, in Gardner v.

TEC Systems, Inc., 725 F.2d 1338, (Fed. Cir. 1984), cert. denied, 469 U.S.

830 (1984), the Federal Circuit held that, where the only difference between

the prior art and the claims was a recitation of relative dimensions of the

claimed device and a device having the claimed relative dimensions would

not perform differently than the prior art device, the claimed device was not

patentably distinct from the prior art device. Appellants provide no evidence

of the criticality of the size of the claimed digital memory card. The

rejection of claim 39 is affirmed for the reasons of record.

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Rejection II

II. Claim 4 is rejected under 35 U.S.C. § 103(a) as being

unpatentable over Westbrook in view of Thompson.

In our Decision dated August 26, 2014, we stated that Rejection II in

the Decision fell for the reasons of record stated in the Answer (Decision

17). We reproduce the arguments of record below for ease of review.

Appellants incorporate their arguments and remarks with respect to

claim 1 in response to this rejection. (App. Br. 13.) We were not persuaded

by Appellants' arguments to claim 1.

We agree with the Examiner's response to Appellants' claim 4

arguments that, "Applicant's statements regarding bandwidth, power, size,

etc. are not in reference to any claimed limitations." (Ans. 17.) The

Examiner is entitled to give the claims their broadest reasonable

interpretation.

The Examiner has found that Thompson is "an analogous reference in

the physiological data monitoring art." (Ans. 10.) We agree.

We have reviewed Appellants' arguments regarding the rejection of

claim 4 on pages 13 and 14 of the Brief, however, we agree with the

Examiner's statement of the rejection on page 10 of the Answer, and do not

find that Appellants have rebutted the Examiner's prima facie case with

respect to claim 4. Appellants have provided no evidence that one of

ordinary skill in the art at the time of the invention would have not been able

to incorporate the encryption technology of Thompson into a device similar

to that of Westbrook. Attorney argument cannot take the place of evidence.

Thompson, which the Examiner notes is "an analogous reference in

the physiological data monitoring art," recognizes the problem in the art of

19



securing medical data which is transmitted stresses the importance of the use

of encryption to enhance the security of patient data. (Ans. 10.) Westbrook

transmits medical data. Therefore, it would have been obvious to one of

ordinary skill in the art at the time of the invention, aware of security

problems with medical data as described in Thompson given the teaching of

Thompson that encryption may be used to secure patient data, to secure the

medical data transmissions of Westbrook. The rejection of claim 4 is

affirmed for the reasons of record in the Answer, page 10.

Rejection III

III. Claim 5 is rejected under 35 U.S.C. § 103(a) as being

unpatentable over Westbrook in view of Auphan.

In our Decision dated August 26, 2014, we stated that Rejection II in

the Decision fell for the reasons of record stated in the Answer (Decision

17). We reproduce the arguments of record below for ease of review.

We are not persuaded by Appellants' arguments, and agree with the

Examiner's response on page 18 of the Answer that Auphan itself provides a

reason to include an ambient sensor in a system for sleep analysis during

sleep monitoring. Auphan i-fi-1 5, 6, 8, 9. It would have been obvious to one

of ordinary skill in the art at the time of the invention aware from Auphan

that measurement of sleep environment is important in sleep monitoring

analysis to incorporate the sleep environment monitoring sensor of Auphan

into the sleep analysis physiological monitoring system of Westbrook

including sensors. We find no evidence of hindsight on the part of the

Examiner, as the Examiner relies on Auphan for the motivation to include an

20



environmental sensor in a sleep monitoring device having sensors.

Rejection III is affirmed for the reasons of record.

Rejection IV

IV. Claims 7, 35--40, and 42--47 are rejected under 35 U.S.C.

§ 103(a) as being unpatentable over Westbrook in view of Fey.

In our Decision dated August 26, 2014, we stated that Rejection IV in

the Decision (including the obviousness rejection over Westbrook and Fey),

fell for the reasons of record stated in the Answer (Decision 17).

Arguments of record are repeated below for ease of review. Essentially, the

Examiner found that Fey was analogous art to Westbrook and the claimed

invention, and that

It would have been obvious to one of ordinary skill in the art at the time of invention to apply the known business methods of Fey to the system of Westbrook to provide the expected results of providing patient care using an ambulatory medical device by giving the patient the device in person, and sending them home to use the device.

(Ans. 11-12.)

IV. ANALYSIS

Claim 7

Westbrook teaches a sleep apnea evaluation system for use in the

home. Westbrook i-f 32. The device of Westbrook "eliminates or reduces

the use of wires, and can be reliably self-applied with minimal instruction

[and] would be beneficial in the accurate diagnosis of sleep disorders." Id.

at i-f 23. Thus, West brook alone teaches providing patients with a sleep

21



apnea device with minimal instruction and sending them home to use the

device. Fey is also relied on by the Examiner to show the common sense

and "the well known rudimentary business practice of examining a patient in

a medical center, providing the patient with a medical recording device, and

returning home to use the device (Fey paragraphs 0040 - 0043)." (Ans. 12.)

The USB memory device of Fey is "for ease of portability and use in

connection with member facilities" (Fey i-f 29), and thus one of ordinary skill

in the art would understand from Fey that the smart drive device including

physiological data (or keychain-type memory device (i-f 5)) of Fey is

returned to the member facility or physician's office. Westbrook teaches all

other limitations of claim 7. The Examiner further found that "the step of

returning the device upon completing the monitoring session would naturally

flow from this business practice, and would also be an obvious modification

of Westbrook." (Id.; see claim 38.)

Appellants essentially are asking the Board to find patentable subject

matter based on common sense ("common knowledge," Ans. 17) and "the

well known rudimentary business practice of examining a patient in a

medical center, providing the patient with a medical recording device, and

returning home to use the device," as disclosed in Westbrook and Fey (Ans.

12).

Appellants ask us to find Fey to be non-analogous art, and argue Fey

cannot be relied on for 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.

22



The test for non-analogous art is whether the art is within the field of

the inventor's endeavor and, if not, whether it is "reasonably pertinent to the

particular problem with which the inventor was involved." Wood, 599 F.2d

at 1032. Here, we do agree with the Examiner's finding that Fey is within

the "analogous art of ambulatory physiological monitoring." Ans. 11-12.

Moreover, we find that the familiar device of Fey, within the field of the

inventor's endeavor, has obvious or reasonably pertinent uses beyond its

primary purpose. KSR, 550 U.S. at 420. Our legal precedent from the

Supreme Court in KSR tells us one "of the ways in which a patent's subject

matter can be proved obvious is by noting that there existed at the time of

the invention a known problem for which there was an obvious solution

encompassed by the patent's claims." Id. at 419. Moreover,

When 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 known options within his or her technical grasp. If this leads to the anticipated technical success, it is likely the product not of innovation but of ordinary skill and common sense.

Id. at 421.

In this case, Fey's medical device,1 is an available, predictable

solution to the problem of providing a patient with a medical device in

1 The Smart card ofFey is a medical data recording and monitoring (observing data) device (i-f 40), and is therefore analogous art to the claimed invention and the medical device of Westbrook. The term "monitor" means, "12. to observe, record, or detect (an operation or condition) with instrument that have no effect upon the operation or condition." http://www.thefreedictionary.com/monitor

23



person, sending them home to use the device (Ans. 12) and returning the

device to a member medical facility, notwithstanding any analogous art

argument Appellants make. The Examiner argues on this record that "the

step of returning the device upon completing the monitoring session would

naturally flow from this business practice [of issuing the device], and would

also be an obvious modification of Westbrook to further the expected results

of providing ambulatory patient care." (Ans. 12.) We agree. The Supreme

Court stated in KSR, that "[r]igid preventative rules that deny recourse to

common sense are neither necessary under, nor consistent with, this Court's

case law." (KSR, 550 U.S. at 421.) It would have been mere common sense

to one of ordinary skill in the art at the time of the invention in view of Fey

that a medical device sent home with a patient, would have been used, and

returned to a physician.

Appellants fail to provide specific argument or evidence that the

patient would be unable to be given the device of Westbrook in person, sent

home to use the device and later return the device, in view of Fey's

disclosure of receiving a medical device, taking it home, and later returning

it to a medical facility. We find that 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.

Our reasoning is consistent with that set forth by the Examiner, i.e.,

that it would have been "common knowledge" to go to a doctor's office,

receive instruction on how to use a medical device, go home to use the

device, use the device, and return the device to the doctor's office. (Ans.

17.) Thus, we do not change the thrust of the Examiner's original argument

in our affirmance.

24



In addition, in the interests of specifically addressing Appellants'

arguments with respect to claim 7, as well as being thorough, we

acknowledge that Appellants particularly argue in the Brief (p. 16) that the

Examiner has failed to provide any objective motivation regarding why one

would even initially select Fey and has further failed to provide any

evidence regarding the reasons why one would combine Fey with

Westbrook. (App. Br. 16.) Appellants argue that, a closer review of the

disclosure of Fey shows that Fey is silent as to ambulatory physiological

monitoring. (Id.) Instead, Fey focuses on providing individuals with health

and wellness information and/or an intervention strategy based on an

individual (App. Br. 16), and nowhere does Fey discuss the actual

ambulatory collection of physiological signals, much less the transmission of

these signals to a remote location as part of a sleep testing process. (See Fey

iTiT 21 and 39--44.)

We take these arguments of Appellants in tum. Appellants argue that

the Examiner did not provide motivation to combine Westbrook and Fey.

We are not persuaded. The Examiner's motivation statement provided that,

"[i]t would have been obvious to one of ordinary skill in the art at the time

of invention to apply the known business methods of Fey to the system of

Westbrook to provide the expected results of providing patient care using an

ambulatory medical device by giving the patient the device in person, and

sending them home to use the device." (Ans. 12.) Thus, the record reflects

that the Examiner provided motivation to combine Westbrook and Fey. "A

claim can be obvious even where all of the claimed features are not found in

specific prior art references, where 'there is a showing of a suggestion or

motivation to modify the teachings of [the prior art] to the claimed

25



invention.'" SIEJA Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d

1349, 1356 (Fed. Cir. 2000) (concluding that patent would have been

obvious in light of teachings in prior art which provided motivation and

suggestion to modify existing techniques to arrive at method in question)."

Ormco Corp. v. Align Tech. Inc., 463 F.3d 1299, 1307 (Fed. Cir. 2006).

As to the issue of "motivation to combine" references, the Supreme

Court in KSR, 550 U.S. at 415, rejected a rigid application of the teaching

suggestion-motivation test. The Court recognized that it is often necessary

to look at the interrelated teaches of multiple references; the effects of

demands of the marketplace; and the background knowledge possessed by a

person of ordinary skill, "all in order to determine whether there was an

apparent reason to combine the known elements in the fashion claimed." Id.

at 418. Moreover, the "obviousness analysis cannot be confined by a

formalistic conception of the words teaching, suggestion, and motivation, or

by overemphasis on the importance of published articles and explicit content

of issued patents." Id. at 419. Finally, one "of the ways in which a patent's

subject matter can be proved obvious is by noting that there existed at the

time of invention a known problem for which there was an obvious solution

encompassed by the patent's claims." Id. The Supreme Court in KSR also

stated that, "[r]igid preventative rules that deny recourse to common sense

are neither necessary under, nor consistent with, this Court's case law." (Id.

at 421.) Furthermore, "[g]ranting patent protection to advances that would

occur in the ordinary course without real innovation retards progress." Id. at

419.

26



In the present case, as indicated by the Examiner in the Answer, Fey

discloses the well known rudimentary business practice of examining a patient in a medical center, providing the patient with a medical recording device, and returning home to use the device (Fey paragraphs 0040 - 0043). It would have been obvious to one of ordinary skill in the art at the time of invention to apply the known business methods of Fey to the system of Westbrook to provide the expected results of providing patient care using an ambulatory medical device by giving the patient the device in person, and sending them home to use the device. Additionally, the step of returning the device upon completing the monitoring session would naturally flow from this business practice, and would also be an obvious modification of Westbrook to further the expected results of providing ambulatory patient care. The devices of Westbrook are ambulatory devices, monitored by technicians, clinicians or doctors. At some point in the normal usage of these devices, the patients must interact with the clinicians, doctors, and technicians and receive instructions or advice for usage of the devices. Such practices are well known in the ambulatory monitoring arts. Therefore, these methods would be obvious to implement in the invention of Westbrook.

(Ans. 12.) In other words, 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 them home to use the device, and

later returning the device. It is proper to "take account of the inferences and

creative steps that a person of ordinary skill in the art would employ." KSR,

550 U.S. at 418. See also id. at 421 ("A person of ordinary skill is also a

person of ordinary creativity, not an automaton."). "In determining whether

obviousness is established by combining the teachings of the prior art, the

test is what the combined teachings of the references would have suggested

27



to those of ordinary skill in the art." In re GPAC Inc., 57 F.3d 1573, 1581

(Fed. Cir. 1995) (internal quotations omitted).

Appellants fail to provide specific argument or evidence that the

device of Westbrook, which is sent home with a patient for in-home testing,

would be unable to be modified with an ambulatory, portable feature as

described in Fey such that the patient would be unable to be given the device

in person, sent home to use the device and later return the device.

Appellants argue that Fey is silent as to ambulatory physiological

monitoring and is non-analogous art. (App. Br. 18.) We are not persuaded.

Fey discloses a medical smart card device (Fey i-f 40, Ans. 12). The smart

card device of Fey is ambulatory, i.e., you can walk around with it. It can be

taken from the medical facility or physician's office to a patient's home, and

returned to a medical facility. Thus, Fey discloses an ambulatory medical

device within the field of the inventor's endeavor. Fey i-f 40,2 in pertinent

part, states that

For example, the user can visit a preventive medical facility in person and have a variety of assessment tests performed. Upon leaving the facility, the user can be presented with the USB smart drive device, and the user can plug the smart drive device into his or her home computer upon returning home.

The smart drive device of Fey allows the user to

input and manage information pertaining to one or more health/ intervention plans established for the user. In one embodiment of the invention, the user-inputted information can be transmitted to the centralized system and one or more health care professionals for evaluation and feedback. The present

2 Cited by the Examiner in the Answer at page 12.

28



invention can further include a plan revision component for updating the one or more health plans based upon the userinputted information.

(Fey i-f 40; Ans. 12.) Thus, the smart drive of Fey records health data which

can be observed (monitored) at home by the patient, as well as by the

physician. Paragraph 41 of Fey (cited by the Examiner in the Answer at

page 12) states that

For example, the user can see summary reports as at 85, body metrics information as at 86, laboratory results as at 87, imaging results as at 88 and research as at 89. The body metrics tab 86 is highlighted in FIG. 8, and on this interface, the user can select a report as at 90, a test explanation as at 91 and an animation for viewing pertaining to the test involved as at 92. The animation can greatly facilitate client learning about the test and its relevance to the client. The body metric tests are identified in the right hand column of the sample interface 84, and the sample test identified in the interface 84 is an NMR TM Lipoprofile test 96. Other tests shown in interface 84 include, for example, complete blood count 93, chemistry panel 94, lipid panel 95, diabetes hemoglobin 97, fibrinogen 98, follicle stimulating hormone 99, gout screen 110, hormocysteine [sic] 111, human growth hormone 112, nutritional panel 113, prostate specific antigen 114, thyroid studies 115, estrogen hormone 116 and lutenizing hormone 117.

Thus, the smart drive of Fey, allows the patient to record and observe

(monitor) his/her blood chemistry, etc. Such data is physiological data.

Thus, we agreed with the Examiner that Fey is within the field of the

inventor's endeavor, an ambulatory, portable, physiological monitoring

device, and is analogous art. Fey discloses a physiological monitoring

device, and is, therefore, also "reasonably pertinent to the particular problem

with which the inventor was involved." Wood, 599 F.2d at 1036.

29



Appellants fail to provide specific argument or evidence that Fey does not

disclose an ambulatory device. Appellants fail to provide specific argument

or evidence that Fey does not disclose a physiological monitoring device.

Appellants fail to show that it would not have been common sense to return

the sleep apnea device sent home with the patient in Westbrook to a

physician or that Fey is not within the same field of endeavor or reasonably

pertinent to the claimed invention or that of Westbrook.

The rejection of claim 7 is affirmed for the reasons of record.

Claim 35

Appellants incorporate their above remarks regarding the

Examiner's failure to demonstrate that "Fey is analogous art, the fact that

Fey does not disclose an ambulatory physiological monitor (much less

methods that include ambulatory physiological monitoring), and the

Examiner's taking of official notice with respect to certain facts allegedly

supported by Fey." (App. Br. 19.)

Arguments with respect to Fey and non-analogous art and ambulatory

physiological monitoring have been addressed in claim 7 and are not

reproduced here. We are not persuaded by Appellants' arguments with

respect to these issues.

Appellants further argue that, "claim 35 specifically requires a 'face

to-face demonstration with instruction and guidance regarding use and

application' of the Appellants' invention, and says nothing of how such a

specific interaction is disclosed by Westbrook." (Id.)

30



The Examiner found that

At some point in the normal usage of these devices, the patients must interact with the clinicians, doctors, and technicians and receive instructions or advice for usage of the devices. Such practices are well known in the ambulatory monitoring arts. Therefore, these methods would be obvious to implement in the invention of Westbrook.

(Ans. 13.) We find that the Examiner has the better argument. The

Examiner's argument is borne out by the fact that the Westbrook device

"can be reliably self-applied with minimal instruction." Westbrook i-f 23.

Furthermore, some type of written or oral instruction is routinely given

within the ordinary course of business when the device of Westbrook is

given to a patient. It would have been obvious to one of ordinary skill in the

art at the time of the invention to provide instructions for use of a patented

device. Both oral and written instructions would have been obvious to one

of ordinary skill in the art.

that

Moreover, the Examiner argued with respect to claim 35 (Ans. 17-18)

Applicant's arguments fail to substantively state why the steps (essentially) of going to a doctor's office, receiving instruction on how to use a medical device, going home to use the device, using the device, and returning the device to the doctor's office are non-obvious and contribute anything of value to common knowledge. The Examiner has provided prior art which actually discusses such a procedure, although such steps (as previously stated) occur in the normal usage of common devices and are well known. Since Applicant has not adequately traversed the rejection as discussed above in the "initial note," the prior art and reasoning of record are sufficient to reject the claim.

31



We agree with the Examiner that the Appellants have failed to provide

sufficient argument or evidence to show that it would not have been obvious,

common sense, or ordinary business practice for one of ordinary skill in the

medical arts to provide instructions for use, whether oral, face-to-face, or

written, for a medical device given to a patient.

The preponderance of the evidence supports a finding of obviousness

of claim 3 5.

Claim 36

Appellants reiterate their "offsite location" argument with respect to

Westbrook which we addressed with respect to claim 1. (App. Br. 13, 20.)

Appellants further argue with respect to claim 3 6 that

the Examiner failed to note that claim 3 6 requires determining a treatment for a subject. Yet, in his rejection of claims 35, 38, 42 and 45 the Examiner openly admitted that "Westbrook ... fails to explicitly state determining a treatment." Since the Examiner has provided neither reasoning nor evidence regarding ways in which Westbrook might implicitly disclose the determination of a treatment, one is left to assume that Westbrook does not disclose this step. Thus, Westbrook provides an insufficient basis on which to rely in rejecting claim 36. Accordingly, the Appellants respectfully request that the Board reverse the Examiner's rejection of claim 36.

(App. Br. 20.)

We are not persuaded by Appellants' arguments. The Examiner

responded to this argument in the Answer, page 18, as follows:

32



The paragraph containing this statement in the rejection of December 12, 2011 does not directly address claim 36.[3] The portion of the rejection that does address claim 36 (see page 11 ), states that Westbrook discloses generating clinician reports of patient status. Clinician reports are indications of whether treatment is necessary, and constitute determinations of treatment. As such, the prior art is sufficient to reject the claim.

In particular, Westbrook 13 i-f 156 discloses

A result report will be designed to meet the needs of both consumers and physicians. For consumers, the overall risk level and recommended actions could be provided. For physicians, the report could include a complete summary of the physiological signals and a full-disclosure presentation of the physiological recordings from the entire session.

In a similar manner, Westbrook discloses that

In the preferred embodiment, the system would include wireless or web-enabled transmission of data to a central monitoring facility capable of storing said data and making comparisons to historical data for that patient. The system would include feedback mechanism to notify designated parties when either compliance or treatment efficacy violates parameters established by the patient's physician, employer, home health care provider and/or by state or federal regulation.

(Westbrook 14 i-f 164.)

Thus, we agree with the Examiner (Ans. 18) both the physician's

reports, and statement that the "compliance or treatment efficacy violates

parameters established by the patient's physician" of Westbrook are

3 Even if the Examiner did make a misstatement that applied to claim 3 6, a correction of the error was later made in the response to arguments section of the Answer.

33



sufficient evidentiary support for the claim requirement of "determining a

treatment, if required for a subject." In the normal course of business the

physician would receive the report and set treatment parameters, thus

"determine a treatment."

Furthermore, Fey (Abstract) discloses

The present invention provides a system, method and device for assisting users in assessing individual health, deriving intervention programs and making health related decisions. A health assessment-intervention component collects and screens diagnostic and demographic data from clients and assists in forming health-care related decisions, action plans and treatment plans. The system can collect and maintain health-related data from third parties such as physicians, researchers, universities and the like, and can provide user accessible personal health records and health decision assistance.

Fey i-f 40, cited by the Examiner (Ans. 12), states that,

In one embodiment of the invention, the user-inputted information can be transmitted to the centralized system and one or more health care professionals for evaluation and feedback. The present invention can further include a plan revision component for updating the one or more health plans based upon the user-inputted information.

Thus, Fey describes development of a health plan based on the physiological

data of Fey. Fey clearly discloses making health related decision based on

assessment of an individual's health, e.g., determining a treatment.

Appellants have failed to respond to the Examiner's argument that

"[c]linicians' reports are indications of whether treatment is necessary, and

constitute determinations of treatment." (Ans. 18.) Appellants' fail to show

Fey's health assessment and making health related decisions does not

34



constitute a determination of treatment. The preponderance of the evidence

of record supports a finding of obviousness of claim 36.

Claim 37

Claim 37 recites a step of, "a step of checking the signals from

the respiratory belt, the nasal airflow sensor and the pulse oximeter for

signal quality until the signals are adequate for later analysis at the subject's

home or the other location remote from the physician's or clinician's office

or place of business."


the Examiner has admitted that Westbrook does not discuss checking signals from a respiratory belt and nasal airflow sensor to ensure that the signals are adequate for later analysis. To bridge this gap, the Examiner alleged that "it would have been obvious to one of ordinary skill in the art of physiological monitoring to apply known signal monitoring techniques to other collected signals, since clinicians would desire the most accurate data available for diagnosis, and since Westbrook discusses the importance of high quality data throughout the reference." Office Action, 10/12/2011, page 11. However, as the Examiner admitted, Westbrook discusses monitoring signal quality for only a forehead-based pulse oximeter. Significantly, Westbrook is silent as monitoring signal quality to ensure adequacy for later analysis for the position sensor and microphone disclosed therein. If, as the Examiner has alleged, such steps would have been desirable "since clinicians would desire the most accurate data available for diagnosis" it is significant that such steps are not even performed for all of the preferred sensors of Westbrook. This makes it even less likely that Westbrook contemplates, much less discloses methods for, monitoring signal quality from a respiratory belt as is required

35



by claim 37. For these reasons the Appellants respectfully submit that the Examiner has failed to produce a prima facie case for rejecting claim 37 on grounds of obviousness.

(App. Br. 20-21.)

The Examiner stated with respect to claim 3 7 that

Regarding claim 3 7, the fact that Westbrook did not explicitly disclose checking signal quality of multiple signals does not preclude a finding of obviousness and a motivation for modifying. Therefore, the Examiner maintains that the modification of Westbrook as discussed in the previous rejection would have been obvious to one of ordinary skill in the art for the reasoning provided, and that the prior art and reasoning is sufficient to reject the claim.

(Ans. 18.) The Examiner found with respect to claim 2, that, "Westbrook

discloses in at least paragraphs 0058, 0061, 0062, 0082, 0158 assessing

sensor signal quality of pulse oximetry signals." (Ans. 7.) Thus, the

Examiner has indicated on this record that Westbrook assesses or checks the

sensor signal quality of pulse oximetry signals. The Examiner's arguments

of record with respect to claim 41 indicate "Westbrook discloses pulse rate

and blood oxygen sensors which utilize photodetectors and accelerometers

in paragraphs 0058, 0061, 0066, 0071, 0135, 0140." (Ans. 10.)

Westbrook i-f 66 (emphasis added) (cited by the Examiner, Ans. 10)

states that

Circuitry of the physiological monitoring system has 12 been designed to provide correct excitation for the LED's and light sensors, power to the sensors, and amplifY and filter the signals with a sampling rate, for example, of 100 samples/sec. The methods used to amplify the AC components of the red and infrared signals, compute the raw Sp02 values, and smooth the data are described in greater detail below. To optimize the

36



accuracy and reliability of the signal input, the Sp02 sensor is offset from the enclosure center to position it near a supraorbital artery of the patient.

(See also Westbrook 108-109.)

We do not find that Appellants have sufficiently rebutted the

Examiner's arguments. The Examiner essentially argues that signal quality

of the pulse oximetry signals is assessed or checked and that it further would

have been obvious to one of ordinary skill in the art to also check signals of

the respiratory belt and nasal airflow sensor. (Ans. 13.) Appellants have

provided no reasoning why it would not have been obvious to one of

ordinary skill in the art to check signals of the respiratory belt and nasal

airflow sensor. Moreover, Westbrook i-f 66 (cited by the Examiner) states

that the "[c]ircuitry of the physiological monitoring system 12 has been

designed to provide correct excitation for the LED's and light sensors,

power to the sensors, and amplify and filter the signals with a sampling

rate." One of ordinary skill in the art would have understood this as

disclosing the periodic sampling of signals from various other sensors and

power supplies to the sensors to assure adequate signal strength. Westbrook

discloses amplifying and filtering signals to provide adequate signal strength

after sampling. The Examiner concluded that

it would have been obvious to one of ordinary skill in the art of physiological monitoring to apply known signal monitoring techniques to other collected signals, since clinicians would desire the most accurate data available for diagnosis, and since Westbrook discusses the importance of high quality data throughout the reference.

37



(Ans. 13.) We find that the preponderance of the evidence supports a

finding of obviousness of claim 37.

Claim 38

The Examiner found that Westbrook did not disclose returning the

device after completion of the monitoring process. (Ans. 12.) However the

Examiner relied on Fey to make up for this deficiency.

Fey, a reference in an analogous art of ambulatory physiological monitoring, discloses the well known rudimentary business practice of examining a patient in a medical center, providing the patient with a medical recording device, and returning home to use the device (Fey paragraphs 0040 - 0043). It would have been obvious to one of ordinary skill in the art at the time of invention to apply the known business methods of Fey to the system of Westbrook to provide the expected results of providing patient care using an ambulatory medical device by giving the patient the device in person, and sending them home to use the device. The devices of Westbrook are ambulatory devices, monitored by technicians, clinicians or doctors. At some point in the normal usage of these devices, the patients must interact with the clinicians, doctors, and technicians and receive instructions or advice for usage of the devices. Such practices are well known in the ambulatory monitoring arts. Therefore, these methods would be obvious to implement in the invention of Westbrook.

(Ans. 12-13.)

Appellants contend that

[I]t is significant to note that Fey does not even discuss returning of the device disclosed therein. This is because, as already noted, the device disclosed in Fey does not collect physiological data, so there would be no need to return the device in order to retrieve data from the device. In addition, the

38



Examiner openly admitted that "Westbrook fails to disclose ... returning the device after completion of the monitoring process." Office Action. 10/12/2011, page 10. If this step is disclosed by neither Fey nor Westbrook, it is difficult, if not impossible, to understand how such a step would "naturally flow" from the combination of Westbrook and Fey as the Examiner has alleged. Further, since an obviousness analysis should be made explicit, KSR Int'! Co. v. Teleflex, Inc., 550 U.S. 398 (2007), such general allegations as something "naturally flowing from" something else are insufficient to carry the Examiner's burden. Thus, the Appellants have requested that the Examiner provide a detailed analysis with appropriate reasoning and support regarding why the Examiner believes that Westbrook or Westbrook in view of Fey explicitly or implicitly discloses returning a "patient interface box and the sensors to a physician's or clinician's office or place of business after the data is collected" as required by claim 38. The Appellants have also requested that if such reasoning and support is within the personal knowledge of the Examiner, the Examiner set forth such knowledge in an affidavit provided pursuant to 37 C.F.R. § 1.104(d)(2). The Examiner has provided no such reasoning, evidence or affidavit. Accordingly, the Appellants respectfully request that the Board reverse the Examiner's rejection of claim 38.

(App. Br. 22.)

We are not persuaded by Appellants' arguments. Fey i-f 40 (emphasis

added) relied on by the Examiner (Ans. 12) states that

In one embodiment of the invention, the user-inputted information can be transmitted to the centralized system and one or more health care professionals for evaluation and feedback. The present invention can further include a plan revision component for updating the one or more health plans based upon the user-inputted information.

Moreover, Fey i-f 43 cited by the Examiner (Ans. 10, 12) states that

39



Upon logging into the system, Mr. Jones can see a variety of general, user non-specific information which augments the previous information he had viewed. He can also view customized information provided by Dr. Philbin, such as, for example, Dr. Philbin's treatment statistics with different patients taking different hypertension medications (nonpersonal information only). Mr. Jones can further receive an intervention plan and/or recommendation from Dr. Philbin as well as the centralized system. In one embodiment of the invention, the intervention plan is provided on the user's smart drive device as he/she is leaving the facility in which he/she was assessed. In another embodiment of the invention, the user's test results and assessment from the physical participation at the facility are evaluated (e.g., by the attending health care professional, by a non-attending professional, or through an automated computer program process combined with a health care professional), and a subsequent intervention plan is made available for the user by logging in to the centralized system.

The "suggestion test is in actuality quite flexible and not only permits,

but requires, consideration of common knowledge and common sense."

DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464

F.3d 1356, 1367 (Fed. Cir. 2006). We agree with the Examiner that it is

common knowledge, common sense, and a well-known business practice

that the smart drive device of Fey is an ambulatory device which can be

returned the physicians' office for updating of a revised intervention plan

during future visits with the physician. Since the device is ambulatory, the

device can be returned to the physician's office by the patient for updating.

The Supreme Court in KSR, 550 U.S. at 415, rejected a rigid

application of the teaching-suggestion-motivation test. The Court

recognized that it is often necessary to look at the interrelated teaches of

40



multiple references; the effects of demands of the marketplace; and the

background knowledge possessed by a person of ordinary skill, "all in order

to determine whether there was an apparent reason to combine the known

elements in the fashion claimed." Id. at 418. Moreover, the "obviousness

analysis cannot be confined by a formalistic conception of the words

teaching, suggestion, and motivation, or by overemphasis on the importance

of published articles and explicit content of issued patents." Id. at 419.

In view of KSR, knowledge of one of ordinary skill in the art that a

smart drive device which is ambulatory and which monitors physiological

data that is overseen by a physician or health care provided, could be

returned to the health care provider for updating. Appellants have failed to

provide sufficient argument or evidence to show that the device of Fey

would be incapable of being returned to the health care provider for updating

or why returning the claimed device is critical to the invention or patentable

subject matter.


of claim 38.

Claim 39

See discussion of claim 39 with respect to rejection 1 above.

The preponderance of the evidence supports a finding of obviousness of

claim 39.

41



Claim 40

Appellants contend that Westbrook and Fey are silent as to the use of

fingertip pulse oximeters. (App. Br. 23.) We are not persuaded. Appellants

argue a version of claim 40 which was not entered by the Examiner.

The Examiner finds that, "Westbrook discloses circuitry in the

monitoring device including circuitry linking sensors to a microcontroller,

analog-to-digital converters, and filtering circuitry which is capable of

removing artifacts (Westbrook paragraphs 0058, 0066, 0158)." (Ans. 13-

14.) Appellants provide no argument to the claim of record. The

preponderance of the evidence supports a finding of obviousness of claim

40.

Claim 42

Appellants contend that Fey is not analogous art and that Westbrook

"'fails to disclose steps of providing a patient the sensor device and

instructions [and] sending the patient home to administer the device per the

instructions.'" (App. Br. 23.)

We direct Appellants' attention to discussion of the analogous art

issue with respect to claim 7 herein and to the "instructions" issue with

respect to claim 3 5 herein. The preponderance of the evidence supports a


Claim 43

Appellants argue that the Examiner fails to show the "offsite location"

limitation and the "determining a treatment" limitation. We direct

Appellants' attention to discussion of the "offsite" issue with respect to

42



claim 1 herein. We direct Appellants' attention to discussion of the

"determining a treatment" limitation with respect to claim 36 herein.


of claim 43.

Claim 44

With respect to claim 44, Appellants "emphasize their remarks

directed at Westbrook's failure to disclose the use of an additional

independent 'photodetector for measuring a subject's physiological

condition including heart rate' as required by claim 41." (App. Br. 24.)

Thus, Appellants argue patentability of claim 44 based its dependency on,

and arguments presented for claim 41.

We agree with the Examiner that a pulse rate sensor which utilizes a

photodetector as described by the Examiner in the Answer at page 10 is a

heart rate sensor.


of claim 44.

Claim 45

Appellants argue that Fey is non-analogous art and that the cited art

fails to disclose returning the monitoring device after completion of the

monitoring process.

We direct the Appellants attention to the discussion of the analogous

art issue with respect to claim 7, and to the "return of the device" argument

with respect to claim 38. The preponderance of the evidence supports a


43



Claim 46

Appellants present the same arguments for claim 46 as presented to

claim 39 concerning the dimensions of the flash memory card. We direct

the Appellants attention to the discussion of claim 39 herein. The


46.

Claim 47

Appellants contend that Westbrook and Fey are silent as to the use of

fingertip pulse oximeters. (App. Br. 26.) We are not persuaded. Appellants

argue a version of claim 4 7 which is not of record.

The Examiner finds that, "Westbrook discloses circuitry in the

monitoring device including circuitry linking sensors to a microcontroller,

analog-to-digital converters, and filtering circuitry which is capable of

removing artifacts (Westbrook paragraphs 0058, 0066, 0158)." (Ans. 13-

14.) Appellants provide no argument to the claim of record. The


47.

CONCLUSION

The cited prior art supports the Examiner's conclusion that the

claimed subject matter is obvious. Rejections I-IV are affirmed for the

reasons herein and as set forth in the Answer, and of record.

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No time period for taking any subsequent action in connection with

this appeal may be extended under 37 C.F.R. § 1.136(a)(l ).

AFFIRMED

cdc

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before the patent trial and appeal board ex parte rani … · 15/10/2015 · on may 15, 2015, the...

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