Ex Parte Malhi

Patent Trial and Appeal Board

Jan 23, 2018

13630475 (P.T.A.B. Jan. 23, 2018)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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Alexandria, Virginia 22313-1450
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/630,475 09/28/2012 Arnaz S. Malhi H-KN-02424US/1216-009US01 9836
77218 7590 01/25/2018
MeHtrnnio Vasionlar - APV Division
EXAMINER
c/o IP Legal Department
3576 Unocal Place
ULSH, GEORGE J
Santa Rosa, CA 95403 ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
01/25/2018 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.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AMAZ S. MALHI
Appeal 2016-008053
Application 13/630,4751
Technology Center 3800
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON REHEARING
This is a request for rehearing under 37 C.F.R. § 41.52 (“Req.
Reh’g.”) of the decision on Appeal (“Decision”), entered October 2, 2017, in
the above-identified application. In the Decision, we: (1) affirmed the
Examiner’s rejection of claims 1—4, 22—24, and 26—28 under 35 U.S.C.
§ 103(a) as obvious over Bonnette in view of Bertolero, and (2) affirmed the
Examiner’s rejection of claim 25 under 35 U.S.C. § 103(a) as obvious over
Bonnette, Bertolero, and Pageard. Decision 19. Appellant has requested
that we designate the affirmance of the rejection of claims 1—4, 22—24, and
1 Appellant identifies the Real Party in Interest as Covidien LP. App. Br. 3.
Appeal 2016-008053
Application 13/630,475
26—28 under 35 U.S.C. § 103(a) as a new grounds of rejection and also that
we reconsider the rejection of these claims.
We grant Appellant’s request to designate the affirmance of the
rejection of claims 1—4, 22—24, and 26—28 under 35 U.S.C. § 103(a) as a
new grounds of rejection. We clarify but decline to modify the Decision
with regard to affirming the obviousness rejections. We address Appellant’s
arguments below.
DISCUSSION
Appellant argues that we upheld the rejection of claims 1—4, 22—24,
and 26—28 under 35 U.S.C. § 103(a) on factually different grounds than the
Examiner. Req. Reh’g 2—5. Specifically, Appellant argues:
In the Decision on Appeal, the Patent Trial and Appeal Board
(PTAB) “agree [d] with Appellant that the sheath portion of the
Bonnette device would traverse the occlusion in addition to the
tip.”8 Since the PTAB agreed that the nitinol tube 26 and outer
sheath 22 disclosed by the Bonnette would traverse the
occlusion, the PTAB disagreed with the Examiner’s assertion
that “the fluid jet is the only thing that crosses the occlusion.”9
Req. Reh’g 4 (citing Decision (fh 8) and Ans. 8 (fh 9)). Appellant’s quote
identifies an incomplete and/or vague statement in our Decision but not a
fault in the underlying factual findings that support our conclusion of
obviousness. We clarify below.
In the Appeal Brief, Appellant argued:
At dozens of locations in the disclosure,28 Bonnette also refers
to “fluid jet crossing catheter 10” (emphasis added) which
includes sheath 22, nitinol tube 26, and tip 34, as shown in FIG.
1 of Bonnette. All of these passages support the reasonable
interpretation that “the device” disclosed by Bonnette as having
a small crossing profile is the entire catheter device that
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Application 13/630,475
includes sheath 22. The Examiner has failed to establish any
other reasonable interpretation of the Bonnette disclosure.
App. Br. 8. Our intent in agreeing with Appellant’s argument at page 8 of
the Decision was simply to recognize that, given the size of the occlusion
shown in Figure 11 with relation to the Bonnette device, the fluid jet stream
102, the cutting tip 34, and a portion of the proximal section of the sheath 22
(housing the nitinol tube 26) may traverse the occlusion as the occlusion is
disrupted by the device. As Appellant has argued (Appeal Br. 8), sheath 22
may provide advantages in maintaining control and directional movement of
tip 34 as it is navigated through the lesion. However, we hereby clarify that
we do not envision the entire sheath 22 traversing the occlusion; instead,
only a portion of sheath 22 (e.g., proximal tip 22a) would be required to
provide control and additional structural support, leaving sufficient length of
sheath 22 to house the proposed balloons 40 and 40’ as proposed by the
Examiner (e.g., Ans. 8).
Accordingly, we clarity our Decision to reflect that we find only those
portions of the device that are necessary to disrupt the occlusion in each
instance, as would be determined by the operator of the device, would
traverse the occlusion: these could include first, the fluid jet stream; second,
the cutting tip 34; and, finally, a portion of the proximal sheath 22a. Our
interpretation is supported by Figure 11, which suggests that the cutting tip
34, which issues the jet stream, is extended beyond the sheath 22 and thus
may proceed through the occlusion as the jet stream clears the occlusion and,
inter alia, by paragraph 47 of Bonnette, describing Figures 9a—9c, which
illustrate the longitudinal positional and slideable relationships
of the tip 34, the bend 36, and a distal portion of the nitinol tube
26 of the jet body 12 to the distal end of the sheath 22 and the
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Application 13/630,475
lumen 98 thereof during nonextension, medium extension, and
large extension positions of the tip 34 near or in a distal
direction beyond an interior distal edge 22a of the sheath 22.
Bonnette at 147, Figures 9a—c. Thus, in some instances, such as where the
occlusion is very small, we find that no portion of the sheath may be
required to traverse the occlusion; our factual finding that some proximal
portion of the sheath 22a may traverse the occlusion is simply a recognition
that Bonnette’s device does not preclude entry of a portion of the proximal
sheath 22a into the occlusion. Our Factual Findings 1—5 support this
interpretation. See Decision 4—7.
The clarification discussed above does not affect our ultimate
conclusion of obviousness, which agreed with the Examiner that the skilled
artisan would have understood from reading Bonnette and Bertolero that
addition of the balloons 40 and 40’ (or individual balloons as desired) that
are taught by Bertolero would provide added steering and stabilization
benefits and would not alter the size of the portion of the catheter that would
traverse the occlusion because the balloons could be placed sufficiently
distal to the advancing tip 22a. Id. at 11. As noted in our Decision, we are
unpersuaded by Appellant’s argument (App. Br. 7—8) that placement of
balloons on the sheath would alter the profile of the portion of the sheath
that crosses the occlusion, particularly because the Appellant provided no
evidence or persuasive argument why placement of the balloons in the distal
position taught in Bonnette would not provide the suggested improvement in
steering and stabilization, or would affect the low profile benefits of the
occlusion-crossing surface of the proposed modified Bonnette device. Id.
As acknowledged in the Request for Rehearing, Bertolero teaches placing
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Application 13/630,475
balloons 40 and 40’ “substantially close to the distal end of sheath 38.” Req.
Reh’g. 6, citing Bertolero 12. We remain persuaded that, absent evidence
or persuasive argument to the contrary, which Appellant has not provided,
Bertolero’s disclosure that use of one or more balloons “may provide
advantages including but not limited to assisting in steering the catheter 100”
and thereby would have encouraged the skilled artisan to incorporate the
balloons to obtain such benefits. See, e.g., Bertolero 127.
Appellant argues that our rationale lacks merit as follows:
[T]he PTAB has not explained why one of ordinary skill in the
art would have recognized that positioning the balloons 40 and
40’ disclosed by Bertolero far enough proximal of Bonnette’s []
tip of sheath 22 to allow sheath 22 to cross the occlusion
“enhance[s] the user’s ability to control the catheter.”20 As
shown in the Examiner-annotated FIG. 11 of Bonnette
reproduced above, the added balloons substantially proximal of
the end of sheath 22 would not have “enhanced” the ability to
control the catheter because there is a substantial portion of
sheath 22 that would be subject to flexing between the balloons
and the tip of sheath 22.
Req. Reh’g. 6.
We are not persuaded. As stated in the Decision, and as cited from
Bertolero above, we agree with the Examiner that Bertolero teaches that use
of such balloons may provide the advantages of better steering and greater
stability, and that the ordinary artisan would have been motivated to modify
the Bonnette device to include such balloons. Decision at 12. Moreover,
Bertolero teaches multiple embodiments of a sheath with affixed inflatable
balloons solely on the distal end of a catheter. See Bertolero Figures 1 A—c,
2A, 2B, 3A, 3B, and 5A. Bertolero discloses that the balloons can be of
different or varying sizes. Id. at 130. Bertolero also discloses that one
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Application 13/630,475
function of such balloon may be to “provide additional traction [by]
press[ing] into the surrounding tissue thereby holding the sheath ... in
place.” Id. at 131.
Appellant’s final argument is that the findings relied upon in the
Decision suggest placing the balloons 40 and 40’ of Bertolero in a position
other than the distal position suggested by Bertolero, and that the skilled
artisan would have been without guidance to know “how far proximal the
distal end of sheath 22 the balloons 40 and 40’ of Bertolero could be
positioned while still achieving stability or control of the distal end of the
sheath 22 and the ability to cross occlusions.” Req. Reh’g. 7—8. Appellant
thus argues it is our burden to provide evidence supporting this proximal
placement. Id. at 8.
While we do not agree that Bertolero suggests placing the balloons
only in a distal position (see, e.g., Figure 4A showing balloons along the
length of the device), the discussion above clarifies that because we find that
Bonnette’s disclosure does not preclude a portion of the sheath 22a passing
through the occlusion (but does not require the entire sheath 22 to do so), a
sufficient length of the sheath 22 would remain outside the occlusion to
house the balloons 40 and 40’ of Bertolero toward the distal end of the
sheath as proposed by the Examiner. Hence, we are not persuaded that our
conclusion regarding the obviousness of the combination of Bonnette and
Bertolero requires additional factual support or differs from that of the
Examiner. Nevertheless, in an abundance of caution, we will designate the
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Application 13/630,475
rejection as a New Ground in order to permit Appellant to provide evidence,
amendment, or otherwise address the rejection.
DECISION
Our decision to affirm the obviousness rejections of the Examiner has
not been shown to have been erroneous. However, in order to provide
Appellant an opportunity to fully respond to the issues in this appeal, we
grant the request for rehearing in part, to the extent that we designate the
Decision a new ground of rejection under 37 C.F.R. § 41.50(b).
37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant
to this paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected, or both,
and have the matter reconsidered by the examiner, in which event the
proceeding will be remanded to the examiner....
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same 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).
REQUEST GRANTED-IN-PART; 37 C.F.R, $ 41.50(b)
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