Ex Parte Aziz et al

Patent Trial and Appeal Board

Feb 13, 2018

13323516 (P.T.A.B. Feb. 13, 2018)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/323,516 12/12/2011 Kusai S. Aziz 40463-703.201 6391
21971 7590 02/15/2018
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
EXAMINER
MEDWAY, SCOTT J
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
02/15/2018 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):
patentdocket @ wsgr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KUSAI S. AZIZ and ROSS TSUGITA
Appeal 2016-001647
Application 13/323,516
Technology Center 3700
Before KEN B. BARRETT, WILLIAM A. CAPP, and
SEAN P. O’HANLON, Administrative Patent Judges.
CAPP, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants1 seek our review under 35 U.S.C. § 134(a) of the non-final
rejection of claims 1-10. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify Atherolysis Medical, Inc., as the real-party-in-interest.
Appeal Br. 3.
Appeal 2016-001647
Application 13/323,516
THE INVENTION
Appellants’ invention relates to an atherolysis catheter apparatus for
treating vascular plaque buildup. Spec. ^ 2. Claim 1, reproduced below, is
illustrative of the subject matter on appeal.
1. An atherolysis catheter comprising:
a catheter body comprising an infusion lumen having at
least one infusion port at a distal end thereof and an aspiration
lumen having at least one aspiration port at a distal end thereof;
a pump disposed in the infusion lumen and configured to
flow a liquid infusate through the infusion lumen toward the
infusion port; and
a pressure-responsive valve disposed at the infusion port,
wherein the valve is normally closed but opens in response to
flow of the liquid infusate caused by the pump.
THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
Schwartz US 5,092,844 Mar. 3, 1992
Hastings US 6,089,235 July 18,2000
Nita US 6,454,757 B1 Sept. 24, 2002
Evans US 6,929,633 B2 Aug. 16, 2005
DiFiore US 2006/0149191 A1 July 6, 2006
The following rejections are before us for review:
1. Claims 1—4, 7, 9, and 10 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Nita, Schwartz, and DiFiore.
2. Claims 5 and 6 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Nita, Schwartz, DiFiore, and Evans.
3. Claims 7 and 8 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Nita, Schwartz, DiFiore, and Hastings.
2
Appeal 2016-001647
Application 13/323,516
OPINION
Unpatentability of Claims 1—4, 7, 9, and 10
over Nita, Schwartz, and DiFiore
Claim 1
The Examiner finds that Nita discloses the invention substantially as
claimed except for a pump and pressure-responsive valve. Final Action 2-3.
The Examiner relies on Schwartz for the pump and DiFiore for the valve.
Id. at 3—4. The Examiner concludes that it would have been obvious to a
person of ordinary skill in the art at the time of the invention to include a
pump within the infusion lumen as taught by Schwartz. Id. at 3. According
to the Examiner, a person of ordinary skill in the art would have done this to
ensure adequate flow. Id. The Examiner also concludes that it would have
obvious to combine DiFiore’s pressure responsive valve with the infusion
catheter of Nita and Schwarz. Id. at 5. According to the Examiner, a person
of ordinary skill in the art would have done this to enable the port to remain
closed when not in use. Id.
Appellants first argue that Nita discloses an ultrasound catheter, not
an atherolysis catheter. Appeal Br. 6. Appellants argue that the purpose of
Nita is to dilate or expand the surrounding tissue to facilitate passage of a
catheter through an obstructed anatomical structure. Id.
Appellants’ argument is not persuasive. It is well settled that the prior
art need not serve the same purpose as that disclosed in Appellants’
Specification in order to support the conclusion that the claimed subject
matter would have been obvious. See In re Lintner, 458 F.2d 1013, 1016
(CCPA 1972). “A reference may be read for all that it teaches, including
uses beyond its primary purpose.” In re Mouttet, 686 F.3d 1322, 1331 (Fed.
Cir. 2012), citing KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 418^121
3
Appeal 2016-001647
Application 13/323,516
(2007). A person of ordinary skill in the art would be familiar with various
types of arterial catheters and would readily foresee that various designs
could be adapted to alternative purposes.
Appellants next argue that Schwartz’s catheter is not in “an analogous
art” and is intended for an entirely different purpose than Nita. Appeal
Br. 6. According to Appellants, Nita is intended for mechanically disrupting
a clot and Schwartz delivers blood past an angioplasty balloon. Id. This
argument is not persuasive. Nita and Schwartz each disclose catheters for
use in arteries. Nita, col. 10,11. 1^16; Schwartz, col. 4,11. 66-68.
Appellants next argue that a skilled artisan would not place a
Schwartz pump in a Nita catheter when Nita merely infuses saline to dilate a
lumen to facilitate passage of the catheter. Appeal Br. 6-7. This is an
individual attack on references that are combined for purposes of a rejection.
It is well settled that non-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references. In re Merck & Co., 800 F.2d 1091, 1097 (Fed.
Cir. 1986); In re Keller, 642 F.2d 413, 425 (CCPA 1981). Once again, a
person of ordinary skill in the art would readily foresee alternative uses for
the multi-lumen catheter of Nita which might benefit from adding a pump.
Moreover, the Examiner provides persuasive reasoning to support the
proposed combination:
a skilled artisan would have been motivated to place the
Schwartz pump in the fluid delivery lumen of the Nita catheter
since Schwartz teaches that a pump within the fluid delivery
lumen would solve numerous problems associated with fluid
delivery using an external pump, namely the long fluid flow
path and the difficulty of controlling the pump based on the
viscosity of fluid chosen for the procedure .... [I]n discussing
4
Appeal 2016-001647
Application 13/323,516
these disadvantages Schwartz specifically cites a prior catheter
that uses a pump external to the body .... A skilled artisan
would thus be motivated, upon reading Schwartz, to modify a
catheter to incorporate a pump within a catheter lumen instead
of an external pump to cure these disadvantages.
Ans. 9 (citing Schwarz col. 1,1. 67 - col. 2,1. 32).
Appellants next argue that Nita and Schwartz teach away from
claimed invention. Appeal Br. 8. We disagree. A reference does not teach
away if it merely discloses an alternative invention but does not “criticize,
discredit, or otherwise discourage” investigation into the invention claimed.
In re Fulton, 391 F.3d 1195, 1201 (Fed.Cir.2004). Appellants have not
directed us to any language in either Nita or Schwarz that criticizes,
discredits, or otherwise discourages investigation into incorporating a pump
into a catheter infusion lumen.
Appellants next argue that DiFiore is not combinable with Nita and
Schwartz. Appeal Br. 9. Appellants argue that DiFiore’s valve is
“contraindicated” with the structures of both Nita and Schwartz. Id.
Appellants argue that Nita’s ports are “tiny” and formed through a metal
head member that is part of the ultrasound transmission assembly of the
catheter. Id. According to Appellants, “[i]t is difficult to see how the
DiFiore slit valve could be substituted into the Nita catheter.” Id.
Similarly, Appellants argue that modifying Schwartz with a slit valve would
not make any sense as a slit valve would reduce the flow rate contrary to the
purpose of Schwartz. Id.
Appellants’ arguments are not persuasive as they assume, contrary to
prevailing precedent, that a person of ordinary skill in the art would be
forced to bodily incorporate the features of DiFiore in Nita and Schwarz.
However, the obviousness inquiry does not ask “whether the references
5
Appeal 2016-001647
Application 13/323,516
could be physically combined but whether the claimed inventions are
rendered obvious by the teachings of the prior art as a whole.” In re Etter,
756 F.2d 852, 859 (Fed. Cir. 1985) (en banc). “The test for obviousness is
not whether the features of a secondary reference may be bodily
incorporated into the structure of the primary reference.” In re Keller, 642
F.2d 413, 425 (CCPA 1981); In re Mouttet, 686 F.3d 1322, 1332 (Fed.
Cir. 2012).
Finally, Appellants argue that the Examiner’s rejection lacks
sufficient reasoning to support the proposed combination. With respect to
the Examiner’s statement that use of DiFiore’s valve would enable the port
to remain closed when not in use to curtail undesirable fluid communication
(Final Action 5),2 Appellants argue that they “are at a complete loss to
understand where this dangerous fluid contamination is coming from.”
Appeal Br. 10.
Appellants’ arguments are not persuasive. The Examiner views using
a seal to prevent a backflow of fluid into the infusion lumen as a beneficial
improvement. Final Action 5. This reasoning is sufficient to support the
rejection, as it is well settled that “any need or problem known in the field of
endeavor at the time of invention and addressed by the patent can provide a
reason for combining the elements in the manner claimed.” KSR, 550 U.S.
at 420.
We have considered Appellants’ remaining arguments, including the
Nita multiple embodiment argument at page 7 of the Reply Brief, and find
2 We view the reference to Hynes at page 5 of the Final Action to be an
inadvertent typographic error and that the Examiner intended, instead, to
refer to the Nita reference. Final Action 5. Appellants appear to have
similarly understood this to be an inadvertent error. See Appeal Br. 10.
6
Appeal 2016-001647
Application 13/323,516
them to be without merit. Thus, in view of the foregoing discussion, we
determine the Examiner's findings of fact are supported by a preponderance
of the evidence and that the Examiner's legal conclusion of unpatentability is
well-founded. Accordingly, we sustain the Examiner's unpatentability
rejection of claim 1.
Claims 2—4
Claims 2—4, argued together, depend, directly or indirectly, from
claim 1 and, among others, add the limitation: “wherein the pressure
responsive valve comprises a valve plug reciprocatably mounted in the
infusion port, wherein the infusion port defines a valve seat.” Claims App.
The Examiner finds that DiFiore discloses plug 317 mounted in an infusion
port as claimed. Final Action 4.
Appellants argue that DiFiore fails to disclose a valve that
reciprocates as claimed. Appeal Br. 10-11. We have reviewed Figure 33
and considered the following passage from DiFiore:
As shown in FIG. 33, the shear forces and their resulting
stresses enable active valve wall member 317 to move in a
direction indicated by arrow 340, and enables infusion valve
300 to open outwardly in response to the forces acting on
catheter body 282 as a result of the imposition of a positive
pressure differential between lumen 292 and the exterior of
catheter body 282. Fluid 336 is shown flowing out from
lumen 292 to the exterior of catheter body 282 in response to a
positive pressure differential there between.
DiFiore ^ 190. In view of the foregoing disclosure, the Examiner’s finding
that DiFiore discloses a valve that reciprocates is supported by a
preponderance of the evidence.
Appellants accuse the Examiner of engaging in improper hindsight.
Appeal Br. 11-12. However, such an argument is of no moment where, as
7
Appeal 2016-001647
Application 13/323,516
here, the Examiner provides a sufficient, non-hindsight reason to combine
the references. See In re Cree, 818 F.3d 694, 702, n.3 (Fed. Cir. 2016).
We sustain the Examiner’s unpatentability rejection of claims 2^1.
See 37 C.F.R. § 41.37(c)(l)(iv) (claims argued as a group).
Claims 7, 9, and 10
Claims 7, 9, and 10 depend, directly or indirectly, from claim 1 and
are not argued separately. Claims App. We sustain the unpatentability
rejection of claims 7, 9, and 10 over Nita, Schwartz, and DiFiore. See 37
C.F.R. § 41.37(c)(iv) (failure to separately argue claims).
Unpatentability of Claims 5 and 6
over Nita, Schwartz, DiFiore, and Evans
Claim 5 depends from claim 1 and adds the limitation: “further
comprising a pair of axially spaced-apart isolation balloons, with a distal
balloon disposed on the catheter body distally of the infusion port and the
aspiration port and a proximal balloon disposed proximally of the infusion
port and the aspiration port.” Claims App.3 The Examiner relies on Evans
as disclosing axially spaced-apart balloons. Non-Final Action 7. The
Examiner concludes that it would have been obvious to a person of ordinary
skill in the art at the time of the invention to implement the teachings of
Evans together with Nita, Schwartz, and DiFiore to achieve the claimed
invention. Id. at 7-8. According to the Examiner, a person of ordinary skill
in the art would have done this to stabilize the catheter. Id.
Appellants raise the same arguments that we considered in connection
with the rejection of claim 1 and found unpersuasive, and which we find
3 Claims 5 and 6 are argued together and we select claim 5 as representative.
37 C.F.R. §41.37(c)(l)(iv).
8
Appeal 2016-001647
Application 13/323,516
equally unpersuasive here. Appeal Br. 12. Appellants also argue that Evans
teaches a catheter with an internal impeller which is rotated within the
infusion body while fluid is being aspirated. Id. Appellants argue that the
driveshaft associated with the impeller is incompatible with a separate
infusion pump within the infusion lumen as required by claim 1. Id.
Appellants’ abbreviated argument is not persuasive, as it is conclusory
and unsupported by any sound or persuasive technical reasoning that
explains why the teachings of Evans are incompatible with the combined
teachings of Nita, Schwartz, and DiFiore. Thus, we are not apprised of error
and we sustain the Examiner’s rejection of claims 5 and 6.
Unpatentability of Claims 7 and 8
over Nita, Schwartz, DiFiore, and Hastings
Appellants do not argue for the separate patentability of claims 7
and 8 apart from arguments presented with respect to claim 1 which we have
previously considered. We sustain the rejection of claims 7 and 8 over Nita,
Schwarz, DiFiore, and Hastings. See 37 C.F.R. § 41.37(c)(iv) (failure to
separately argue claims).
DECISION
The decision of the Examiner to reject claims 1-10 is 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
9