Ex Parte Barak et al

Board of Patent Appeals and Interferences

Jun 23, 2009

11023894 (B.P.A.I. Jun. 23, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte JACOB BARAK, ADI DAGAN, and AMIR FABIAN
____________

Appeal 2009-001150
Application 11/023,894
Technology Center 3700
____________

Decided:1 June 23, 2009
____________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1-30, the only
claims pending in this application. We have jurisdiction under 35 U.S.C.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2009-001150
Application 11/023,894

§ 6(b).

STATEMENT OF THE CASE
The claims are directed to a system for applying pressure to a limb of
a body (claims 1-9, 12-20); a compression system for applying therapeutic
pressure to a limb of a body (claims 10 and 11); and a method of providing
therapy to a limb of a patient with a pressure device (claims 21-30). Claims
1, 7, 12, and 17 are illustrative:
1. A system for applying pressure to a limb of a body, comprising:
a compression system to provide controlled therapeutic pressure to a
limb of a body to generate an induced venous flow; and
a sensor, in operative communication with said compression system,
to measure a venous phasic flow of a patient and to provide data
representing the measured venous phasic flow to said compression system;
said compression system, in response to said sensor, providing
controlled therapeutic pressure to a limb of a body such that the induced
venous flow generated by said compression system will be in-phase with the
measured venous phasic flow of the patient.

7. The system as claimed in claim 1, wherein said sensor is an air
pletysmographic [sic] device.

12. A system for applying pressure to a limb of a body, comprising:
a compression system to provide controlled therapeutic pressure to a
limb of a body to generate an induced venous flow; and
a respiration sensor, in operative communication with said
compression system, to measure a respiration cycle of a patient and to
provide data representing the measured respiration cycle to said compression
system;
said compression system, in response to said respiration sensor,
providing controlled therapeutic pressure to a limb of a body such that the
induced venous flow generated by said compression system will be in-phase
with a venous phasic flow of the patient.

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17. The system as claimed in claim 12, wherein said compression
system provides an electrical stimulus to cause muscles of a limb of a body
to contract and generate the induced venous flow.
The Examiner relies on the following evidence:
Tumey US 5,674,262 Oct. 7, 1997
Watson et al. US 6,231,532 B1 May 15, 2001
McEwen et al. US 6,544,202 B2 Apr. 8, 2003
Oser et al. US 6,592,527 B2 Jul. 15, 2003
Mitchell US 6,810,542 B1 Nov. 2, 2004
Hui US 7,048,702 B2 May 23, 20062

The rejections presented by the Examiner are as follows:
1. Claims 1-4, 6, 10, and 21-24 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Tumey.
2. Claims 1-3, 5, 8-11, and 21-24 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Watson.
3. Claims 1-3, 5, 6, 10, and 11 stand rejected under 35 U.S.C § 103(a) as
unpatentable over Hui.
4. Claim 7 stands rejected under 35 U.S.C § 103(a) as unpatentable over the
combination of Tumey and Oser.
5. Claims 12-16, 18-20, and 25-30 stand rejected under 35 U.S.C § 103(a)
as unpatentable over the combination of Hui and Mitchell.
6. Claim 17 stands rejected under 35 U.S.C § 103(a) as unpatentable over
the combination of Hui, Mitchell and Tumey.
We reverse.

2 Hui claims priority to Provisional Application No. 60/388,212, filed June
13, 2002.
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Anticipation:
PRINCIPLES OF LAW
Because the hallmark of anticipation is prior invention, the
prior art reference – in order to anticipate under 35 U.S.C. §
102 – must not only disclose all elements of the claim within
the four corners of the document, but must also disclose those
elements “arranged as in the claim.” Connell v. Sears, Roebuck
& Co., 722 F.2d 1542, 1548 (Fed.Cir.1983).

Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008).

Tumey:
ISSUE

Does Tumey teach the application of pressure to a limb of a patient
that is in-phase with the venous phasic flow of the patient?

FINDINGS OF FACT
FF 1. Appellants disclose that
phasic flow is created mainly by the changes in the intra-
abdominal pressure that is caused by the respiration
mechanism. During inspiration, the contraction of the
diaphragm muscle causes an increase in the intra-abdominal
pressure, and the contrary happens during expiration.
Triggering the compression cycle regardless of the natural
phasic venous flow creates non-consistent, non-reproducible
pick [sic, peak?] venous velocities.
In other words, the effects of external compression being
applied during expiration (when the intra-abdominal pressure is
least) will be positively reinforced and/or enhanced by the
lower intra-abdominal pressure, the lower pressure acting to
draw the blood, thereby effectively increasing the potential pick
[sic] venous velocity. On the other hand, the effects of external
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compression being applied during inspiration (when the intra-
abdominal pressure is greatest) will be adversely impacted
and/or diminished by the higher intra-abdominal pressure, the
higher intra-abdominal pressure acting to block or pushback the
blood flow, thereby effectively lowering the potential pick [sic]
venous velocity and compromising the efficacy of the device.

(Spec. ¶¶ 0023 and 0024.)

FF 2. Tumey teaches a “device and method for stimulating blood flow
velocity in a leg of the body for the prevention of Deep Vein Thrombosis”
(Tumey, Abstract).
FF 3. Tumey teaches that the device comprises a sensing means that senses
the blood fill status within a foot, wherein the sensing means is connected to
and is capable of triggering a compression means in response to the blood
fill status of the foot (Tumey, col. 2, ll. 2-5).
FF 4. Tumey discloses the use of a photo-plethysmographic sensor that
utilizes three infrared light emitting diodes (LED’s) and one
infrared phototransistor to measure the amount of blood in the
microvascular bed approximately one to two mm beneath the
surface of the skin. This measurement is believed to be
indicative of the volume of blood in the region over which the
sensor is placed, and in this case is indicative of the volume of
blood in the patient’s calf.

(Tumey, col. 4, ll. 26-37.)

FF 5. By way of example, Tumey suggests that “the calf pump could be
engaged when the amount of blood volume in the calf has reached some
maximum point relative to its normal resting baseline” (Tumey, col. 4, ll.
46-48).
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FF 6. Tumey’s “invention generates a series of rapid pulsatile contractions
in succession each of which cause blood to spurt up the deep vein system
and out of the calf, while at the same time, the superficial system is emptied
into the deep vein system” (Tumey, col. 3, l. 5-9).

ANALYSIS
Appellants contend that Tumey’s system induces venous flow that is
out of phase with the patient’s venous phasic flow (Reply Br. 3). In support
of this contention, Appellants explain that “during inspiration, the diaphragm
descends increasing intra-abdominal pressure, slowing or inhibiting the
blood flow towards the heart. This slowing or inhibiting of the blood flow
towards the heart would cause the blood volume in a patient’s calf to
increase” (Reply Br. 4). “Tumey teaches that compression is triggered based
upon the increase in the blood volume in a patient’s calf” (id. (emphasis
removed)). Thus, Tumey teaches the application of pressure to induce
venous flow that “would be out-of-phase with the venous phasic flow of the
patient because triggering compression during inspiration would cause the
compression system to work against the slowing or inhibiting effects of
inspiration” (id.). We agree.
The Examiner fails to identify and we do not find a teaching in Tumey
to apply pressure to a limb of a patient that is in-phase with the venous
phasic flow of the patient.

CONCLUSION OF LAW
Tumey fails to teach the application of pressure to a limb of a patient
that is in-phase with the venous phasic flow of the patient.
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The rejection of claims 1-4, 6, 10, and 21-24 under 35 U.S.C. § 102(b)
as being anticipated by Tumey is reversed.

Watson:
ISSUE

Does Watson teach the application of pressure to a limb of a patient
that is in-phase with the venous phasic flow of the patient?

FINDINGS OF FACT
FF 7. Watson’s “invention relates to a method for augmenting blood flow
by applying pressure to a limb and determining the time for the venous
system in a limb to refill with blood” (Watson, col. 1, ll. 64-63).
FF 8. Watson teaches that “compressive pulses can be provided to the limb
once it has refilled” (Watson, col. 2, ll. 11-12).

ANALYSIS
Appellants contend that Watson’s system induces venous flow that is
out of phase with the patient’s venous phasic flow (Reply Br. 10 and 12). In
support of this contention, Appellants explain that “during inspiration, the
diaphragm descends increasing intra-abdominal pressure, slowing or
inhibiting the blood flow towards the heart. This slowing or inhibiting of the
blood flow towards the heart would cause the blood volume in a patient’s
calf to increase” (Reply Br. 10). Appellants contend that Watson teaches
that compression is triggered based upon the increase in the blood volume in
a patient’s calf (Reply Br. 9). Thus, Watson teaches the application of
pressure to induce venous flow that “would be out-of-phase with the venous
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phasic flow of the patient because triggering compression during inspiration
would cause the compression system to work against the slowing or
inhibiting effects of inspiration” (Reply Br. 7-8). We agree.
The Examiner fails to identify and we do not find a teaching in
Watson to apply pressure to a limb of a patient that is in-phase with the
venous phasic flow of the patient.

CONCLUSION OF LAW
Watson fails to teach the application of pressure to a limb of a patient
that is in-phase with the venous phasic flow of the patient.
The rejection of claims 1-3, 5, 8-11, and 21-24 under 35 U.S.C. §
102(b) as being anticipated by Watson is reversed.

Obviousness:
PRINCIPLES OF LAW
Obviousness requires a suggestion of all the elements in a claim
(CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003))
and “a reason that would have prompted a person of ordinary skill in the
relevant field to combine the elements in the way the claimed new invention
does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).

Hui:
ISSUE
Does Hui make obvious the application of pressure to a limb of a
patient that is in-phase with the venous phasic flow of the patient?

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FINDINGS OF FACT
FF 9. Hui teaches that “[e]xternal counterpulsation is a noninvasive,
atraumatic means for assisting and increasing circulation in patients” (Hui,
col. 1, ll. 21-22).
FF 10. Hui’s “invention relates to an external counterpulsation apparatus
and method for controlling the same” (Hui, col. 1, ll. 13-14).
FF 11. Hui teaches that
External counterpulsation uses the patient’s physiological
signals related to their heart cycle (e.g., electrocardiograph
(ECG)), blood pressure, blood flow) to modulate the inflation
and deflation timing of sets of compressive cuffs wrapped
around a patient’s calves, lower thighs and/or upper thighs,
including the lower buttocks. The cuffs inflate to create a
retrograde arterial pressure wave and, at the same time, push
venous blood return from the extremities to reach the heart at
the onset of diastole. The result is augmented diastolic central
aortic pressure and increased venous return. Rapid,
simultaneous deflation of the cuffs produces systolic unloading
and decreased cardiac workload. The end results are increased
perfusion pressure to the coronary artery during diastole, when
the heart is in a relaxed state with minimal resistant [sic] to
blood flow; reduced systolic pressure due to the “sucking
effect” during cuff deflation; and increased cardiac output due
to increased venous return and reduced systolic pressure.

(Hui, col. 1, ll. 23-40.)

ANALYSIS
Appellants contend that Hui’s compression cycle “is triggered to
minimize end diastolic pressure” (Reply Br. 13). In this regard, Appellants
contend that
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the Examiner has failed to demonstrate how one of ordinary
skill in the art would be able to apply the measurement of
venous phasic flow to minimize end diastolic pressure because
Hui clearly fails to provide any teachings showing a nexus
between venous phasic flow and minimized end diastolic
pressure.

(Id.) We agree.
The Examiner fails to identify and we do not find a teaching or
suggestion in Hui to apply pressure to a limb of a patient that is in-phase
with the venous phasic flow of the patient.

CONCLUSION OF LAW
Hui fails to make obvious the application of pressure to a limb of a
patient that is in-phase with the venous phasic flow of the patient.
The rejection of claims 1-3, 5, 6, 10, and 11 under 35 U.S.C § 103(a)
as unpatentable over Hui is reversed.

The combination of Tumey and Oser:

ISSUE
Does Oser make up for the deficiencies in Tumey?

FINDINGS OF FACT
FF 12. The Examiner finds that Tumey fails to teach “an air
plethysmographic sensor” (Ans. 9).
FF 13. The Examiner relies on Oser to teach “that it is well known in the art
that plethysmography can be carried out in a very wide variety of ways such
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as water plethysmography, air plethysmography or strain gauge
plethysmography” (id.).
ANALYSIS
Claim 7 depends from and further limits the sensor of claim 1 to an air
plethysmographic device. The Examiner relies on Tumey to teach the
system of claim 1, and Oser to teach the use of an air plethysmographic
device, as is required by claim 7 (FF 12-13).
However, as discussed above, Tumey fails to teach the application of
pressure to a limb of a patient that is in-phase with the venous phasic flow of
the patient. The Examiner fails to identify and we do not find a teaching in
Oser to make up for this deficiency in Tumey.

CONCLUSION OF LAW
Oser fails to make up for the deficiencies in Tumey.
The rejection of claim 7 under 35 U.S.C § 103(a) as unpatentable over
the combination of Tumey and Oser is reversed.

The combination of Hui and Mitchell:

ISSUE
Does Mitchell make up for the deficiencies in Hui?

FINDINGS OF FACT
FF 14. The Examiner finds that Hui fails to teach “a sensor for measuring a
respiration cycle” (Ans. 10).
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FF 15. The Examiner relies on Mitchell to teach “a device for assisting and
increasing lymphatic flow and suggests that respiration sensors may be used
so that the device may be coordinated with the phases of respiration:
inhalation and expiration (col. 3, lines 5-11)” (id.).
FF 16. More specifically, Mitchell’s “invention relates to devices for lifting
and manipulating the thoracic cage to improve lymphatic flow” (Mitchell,
col. 1, ll. 10-11).

ANALYSIS
As Appellants explain, “Mitchell fails to teach or suggest the
application of any compression to the patient’s body” (Reply Br. 17
(emphasis removed)). In this regard, Appellants contend that
[t]he Examiner has failed to demonstrate how a device of
Mitchell, which lifts a patient’s body in accordance with the
patient’s respiration, is relevant to the measurement of a
respiration cycle of a patient and the provision of a controlled
therapeutic pressure to a limb of a body such that the induced
venous flow generated by the compression system will be in-
phase with a venous phasic flow of the patient.

(Id.) We agree.
As discussed above, Hui fails to teach or suggest the application of
pressure to a limb of a patient that is in-phase with the venous phasic flow of
the patient. The Examiner fails to identify and we do not find a teaching in
Mitchell to make up for this deficiency in Hui.

CONCLUSION OF LAW

Mitchell fails to make up for the deficiencies in Hui.
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The rejection of claims 12-16, 18-20, and 25-30 under 35 U.S.C §
103(a) as unpatentable over the combination of Hui and Mitchell is reversed.
The combination of Hui, Mitchell and Tumey:

ISSUE
Do Mitchell and Tumey make up for the deficiencies in Hui?

FINDINGS OF FACT
FF 17. The Examiner finds that the “combined references disclose the
claimed invention except for an electrical stimulus to cause muscles of a
limb of a body to contract and generate the induced venous flow” (Ans. 11).
FF 18. The Examiner finds, however, that “Tumey teaches a compression
system having a FES device . . . that provides an electrical stimulus (col. 5,
lines 14-67) to cause muscles of a limb of a body to contract and generate
the induced venous flow” (id.).

ANALYSIS
As discussed above, each of Hui and Tumey fail to teach or suggest
the application of pressure to a limb of a patient that is in-phase with the
venous phasic flow of the patient. In addition, the foregoing discussion
establishes that Mitchell fails to make up for the deficiencies in Hui. In sum,
the Examiner has failed to explain how the combination of these references
teaches or suggests the application of pressure to a limb of a patient that is
in-phase with the venous phasic flow of the patient.

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CONCLUSION OF LAW
Mitchell and Tumey fail to make up for the deficiencies in Hui.
The rejection of claim 17 under 35 U.S.C § 103(a) as unpatentable
over the combination of Hui, Mitchell and Tumey is reversed.

REVERSED

cdc

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