Ex Parte Faul et al

Patent Trial and Appeal Board

Sep 21, 2016

13241497 (P.T.A.B. Sep. 21, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/241,497 09/23/2011 John Faul
39843 7590 09/23/2016
BELL & ASSOCIATES
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
S03_013_DIVl_CONl 1055
EXAMINER
58 West Portal Avenue No. 121 DEAK,LESLIER
SAN FRANCISCO, CA 94127
ART UNIT PAPER NUMBER
3761
NOTIFICATION DATE DELIVERY MODE
09/23/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
abell@bell-iplaw.com
mkaser@bell-iplaw.com
info@bell-iplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN FAUL,
TOSHIHIKO NISHIMURA,
PETER KAO, and
RONALD PEARL
Appeal2014-006658
Application 13/241,497
Technology Center 3700
Before MICHAEL L. HOELTER, ERIC C. JESCHKE, and
GORDON D. KINDER, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from a final
rejection of claims 25 and 27-33. App. Br. 3. Claims 1-24 and 26 have
been canceled. App. Br. 11 (Claims Appendix). We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
Appeal2014-006658
Application 13/241,497
THE CLAIMED SUBJECT MATTER
The disclosed subject matter "relates to implanted medical devices. In
particular, the present invention relates to an arterio-venous shunt." Spec.
i-f 2. Claim 25 is the sole independent claim. Claim 25 illustrates the claims
on appeal and is reproduced below.
25. An apparatus for therapy in a human, comprising:
a long-term implantable arterio-venous shunt device
configured for placement between an aorta and an inferior vena
cava in said human to divert a portion of the blood from the
arterial circulatory system to the venous circulatory system to
decrease the systemic vascular resistance, wherein the shunt
device has an opening with a diameter selected to provide a
blood flow rate through said shunt device of at least 5 ml/min
after said implantation between the aorta and the inferior vena
cava.
REFERENCES RELIED ON BY THE EXAMINER
Douglas US 5,662,711 Sept. 2, 1997
Khosravi US 5,824,054 Oct. 20, 1998
Stergiopulos WO 01/05463 Al Jan 25, 2001
P.A. Khouqeer: Surgical Treatment of Pulmonary Hypertension, A
Proposal for A Novel Procedure: The Khouqeer Shunt. The Internet
Journal of Thoracic and Cardiovascular Surgery. 1999 Volume 2
Number 2 (hereinafter "Khouqeer").
THE REJECTIONS ON APPEAL
Claims 25, 27, and 33 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Khouqeer.
Claim 32 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Khouqeer and Khosravi.
Claims 28-30 are rejected under 35 U.S.C. §103(a) as unpatentable
over Khouqeer and Douglas.
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Appeal2014-006658
Application 13/241,497
Claims 28-31 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Khouqeer and Stergiopulos.
ANALYSIS
The rejection of claims 25, 27, and 33
as unpatentable over Khouqeer
Appellants argue claims 25, 27, and 33 together. App. Br. 6-9. We
select independent claim 25 for review, with dependent claims 27 and 33
standing or falling with claim 25. See 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner relies solely on the teachings of Khouqeer for the
rejection of claim 25. Final Act. 2-3. The Examiner finds that Khouqeer
teaches all the limitations recited therein and also that, in view of
Poiseuille' s Law1 regarding flow rates through a tube, it would have been
obvious "to select a tube with a diameter to generate the desired flow rate, as
taught by Khouqeer. "2 Final Act. 2-3.
Appellants acknowledge, "Khouqeer discloses a shunt and associated
technique for treating pulmonary hypertension," but contend that
1 Appellants' Specification states, "[i]n case the shunt device is a cylinder[,]
then the parameters of the lumen of the shunt device that determine the
blood flow rate through its lumen can be determined with the Poiseuille
equation." Spec. i-f 43. Appellants' Specification also states that the volume
flow rate "is a function of a blood with viscosity y, the pressure difference
AP across the lumen of the shunt device, length l of the lumen of the shunt
device and radius r of the lumen of the shunt device." Spec. i-f 44. The
Examiner notes these teachings in Appellants' Specification stating, "a
skilled artisan would have a basic understanding of Poiseuille's [L]aw and
would be able to adjust the shunt dimensions in order to achieve a desired
flow rate." Ans. 7.
2 Khouqeer states, "[t]he length and size of the tube graft can be estimated
mathematically preoperatively according to the blood flow characteristics,
the current and the desired postop hemodynamic." Khouqeer 3/4.
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Appeal2014-006658
Application 13/241,497
Khouqeer's "structure is opposite of that claimed by the present
application." App. Br. 6. Appellants thereafter do not address structural
differences between the respective shunts, but instead different usages of the
respective shunts. See App. Br. 6-7; Reply Br. 2. Appellants state that the
claimed shunt "diverts blood from a high pressure, high oxygen vessel
(the aorta) to a low pressure, low oxygen vessel (the inferior vena cava)."
App. Br. 6. Whereas "the Khouqeer shunt diverts blood from a high
pressure, low oxygen vessel (the pulmonary artery or one of its main
branches) to a low pressure, high oxygen vessel (the left atrium or one of
the pulmonary veins.)" App. Br. 6. In other words, "[ s ]uch flow is
opposite of that claimed by the present application." App. Br. 6; see also
Reply Br. 4.
The only "opposite" detected in the above statement is one of oxygen
content, and the Examiner states that Appellants "do[] not elucidate how the
oxygen concentration of the targeted vessels or the blood flowing through
the shunt affects the configuration of the shunt." Ans. 6. Further, the
Examiner states that Appellants "fail[] to set forth what structural elements
of the instantly claimed shunt distinguish it from the shunt disclosed by
Khouqeer." Ans. 6.
Appellants contend that the two shunts "would necessarily be
structurally distinct from" each other because the claimed shunt "must have
a structure that lies nearly flat against the walls of both vessels." App. Br. 7;
see also Reply Br. 2. However, the Examiner states, "[t]he shunt disclosed
by Khouqeer is capable of being placed in such a manner" (Ans. 6), and
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Appeal2014-006658
Application 13/241,497
further, it is noted that claim 25 does not recite a "flat against the walls"
limitation. 3
Appellants also contend that Khouqeer' s shunt "would necessarily
have a length of at least several centimeters" but does not indicate where this
"length" limitation is recited or how Khouqeer's supposedly longer shunt
fails to disclose the recited limitations. App. Br. 7; Reply Br. 2. As stated
by our reviewing court in In re Hiniker Co., 150 F.3d 1362, 1369 (Fed. Cir.
1998), "the name of the game is the claim."
Appellants further contend that Khouqeer does not disclose a shunt
"with a diameter selected to provide a blood flow rate through said shunt
device of at least 5 ml/min." App. Br. 7; see also Reply Br. 3. However, as
indicated supra, the Examiner referenced Poiseuille's Law, and Appellants
do not explain how the implementation of this Law to calculate a flow rate is
beyond the ability of one skilled in the art. Final Act. 2-3. Neither do
Appellants indicate how the claimed flow rate of "at least 5 ml/min"
achieves a result which is unexpected or different than what would have
been predictable. 4
3 Features that do not appear in a claim cannot be relied on for patentability.
See In re Self, 671 F.2d 1344, 1348 (CCPA 1982).
4 On this point, Appellants state, "[n]or would the Khouqeer shunt be
expected to have the same configuration and dimensions as the apparatus
claimed since the Khouqeer shunt is intended for a fundamentally different
treatment protocol." App. Br. 8. A recitation of the intended use of the
claimed invention must result in a structural difference between the claimed
invention and the prior art in order to patentably distinguish the claimed
invention from the prior art. Otherwise, if the prior art structure is capable
of performing the intended use, then it meets the claim. In other words,
claims directed to an apparatus, as here, must be distinguished from the prior
art in terms of structure rather than function. See In re Schreiber, 128 F.3d
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Appeal2014-006658
Application 13/241,497
Appellants also proffer two declarations by the lead inventor, John L.
Faul, discussing a series of experiments involving the implantation of a
shunt into a number of patients. App. Br. 8. These will be designated the
"January Declaration" and the "July Declaration." Appellants contend that
these declarations indicate that those patients having the shunt experienced
"significantly increased cardiac output, significantly lowered mean arterial
blood pressure, and significantly decreased systemic vascular resistance."
App. Br. 8; see also January Declaration i-fi-1 7, 8; July Declaration i1 9.
Assuming this to be the case, these declarations are not persuasive that the
structure of the claimed shunt is non-obvious over the structure of
Khouqeer' s shunt coupled with the implementation of Poiseuille' s Law
regarding the desired size of the shunt. See also Ans. 8.
Accordingly, based on the record presented, we sustain the
Examiner's rejection of claims 25, 27, and 33.
The rejection of (a) claim 32 as unpatentable over Khouqeer and Khosravi;
(b) claims 28-30 as unpatentable over Khouqeer and Douglas; and, (c)
claims 28-31 as unpatentable over Khouqeer and Stergiopulos
For each of these dependent claims, the Examiner additionally relies
on the teachings of either Khosravi, Douglas, or Stergiopulos for disclosing
the additional limitation recited therein. Final Act. 3-5. Appellants do not
dispute the Examiner's reliance on these additional references, or their
teachings. Instead, Appellants contend that each of Khosravi, Douglas, or
Stergiopulos "has not been shown to cure the deficiencies of Khouqeer."
App. Br. 9.
1473, 1477-78 (Fed. Cir. 1997); see also Hewlett-Packard Co. v. Bausch &
Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) ("apparatus claims cover
what a device is, not what a device does").
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Appeal2014-006658
Application 13/241,497
Appellants' contentions are not persuasive of Examiner error. We
sustain the Examiner's rejections of claims 28-32.
DECISION
The Examiner's rejections of claims 25 and 27-33 are affirmed.
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 )(iv).
AFFIRMED
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