VOLCANO CORPORATION

Patent Trials and Appeals Board

Jan 27, 2021

2020002716 (P.T.A.B. Jan. 27, 2021)

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.
14/266,218 04/30/2014 John Unser 2010P01520US02 5004
24737 7590 01/27/2021
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus Avenue
Suite 340
Valhalla, NY 10595
EXAMINER
CWERN, JONATHAN
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
01/27/2021 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):
katelyn.mulroy@philips.com
marianne.fox@philips.com
patti.demichele@Philips.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________
Ex parte JOHN UNSER, JOSEPH EDWARD BROWN,
MARJA P. MARGOLIS, and MARY LYNN GADDIS
____________________

Appeal 2020-002716
Application 14/266,218
Technology Center 3700
____________________

Before PHILLIP J. KAUFFMAN, ANNETTE R. REIMERS, and
TARA L. HUTCHINGS, Administrative Patent Judges.

KAUFFMAN, Administrative Patent Judge.

DECISION ON APPEAL

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Application 14/266,218

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STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–17 and 19–21, which constitute all
the claims pending in this application. Final Act. 3–9. Claim 18 has been
cancelled. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

CLAIMED SUBJECT MATTER
Appellant’s claims relate to monitoring functional parameters of a
blood vessel when an interventional therapy is administered. Spec. 1. The
method may be applied, for example, to treat deep vein thrombosis, a
medical condition that results from formation of a blood clot (thrombus)
within a vein. Spec. 1–2. When treating deep vein thrombosis, an
exemplary functional parameter that the method monitors is blood pressure
near the thrombus. Spec. 3, 5–6.
Claims 1 and 12 are independent. Claim 1 is illustrative of the
claimed subject matter, and we reproduce it below:

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Volcano
Corporation, a subsidiary of Koninklijke Philips N.V. Appeal Br. 2.
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1. A method for evaluating an interventional therapy applied to
a deep vein thrombosis, the method comprising:
receiving, from a sensing device inserted into a vessel
having a thrombus therein, one or more functional parameters;
assessing the one or more functional parameters within the
vessel to guide the interventional therapy for treating the
thrombus;
providing the interventional therapy for treating the
thrombus, the interventional therapy being provided by an
interventional catheter arranged over the sensing device; and
continuously monitoring changes in the one or more
functional parameters while the delivery of the interventional
therapy is performed to evaluate the interventional therapy,
wherein the one or more functional parameters comprise fluid
flow.

REJECTIONS
I. Claims 1–4, 7–14, 17, and 19–21 are rejected under 35 U.S.C. § 1032
as unpatentable over Riley,3 Liu,4 and Millar.5 Final Act. 3–7.
II. Claims 5 and 15 are rejected under 35 U.S.C. § 103 as unpatentable
over Riley, Liu, Millar, and Mauch.6 Final Act. 7–8.

2 The Examiner analyzed the application under 35 U.S.C. § 103 as amended
by the Leahy-Smith America Invents Act, P.L. 112-29, 125 Stat. 284 (Sept.
16, 2011). Final Act. 2. Because neither Appellant nor the Examiner
appears to contend that the outcome of this appeal would be different under
pre-AIA law, we apply the same law as the Examiner and Appellant.
3 Riley (US 9,314,584 B1, issued Apr. 19, 2016).
4 Liu (US 2009/0264770 A1, published Oct. 22, 2009).
5 Millar (US 4,901,731, issued Feb. 20, 1990).
6 Mauch (US 2010/0023033 A1, published Jan. 28, 2010).
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III. Claims 6 and 16 are rejected under 35 U.S.C. § 103 as unpatentable
over Riley, Liu, Millar, and Cragg.7 Final Act. 8–9.

ANALYSIS
Issue
For each of the three rejections before us, the Examiner relies on
Riley as prior art. Final Act. 3–9.
Appellant contends that Riley is not prior art that may be relied on to
reject the appealed claims under 35 U.S.C. § 103. Appeal Br. 4.
Prior art for purposes of 35 U.S.C. § 103 is determined by reference to 35
U.S.C. § 102. MANUAL OF PATENT EXAMINING PROCEDURE § 2141.01(I)
(9th edition, rev. June 2020). Prior art under 35 U.S.C. § 102(a)(2) includes
“patent[s] issued under [35 U.S.C. § 151, which name] another inventor and
[were] effectively filed before the effective filing date of the claimed
invention.”8
Riley9 claims an effective filing date based on a provisional
application filed June 27, 2011.10 Riley at [24], [60]. Appellant does not
challenge Riley’s effective filing date. Instead, Appellant points out that,

7 Cragg (US 6,063,069, issued May 16, 2000).
8 35 U.S.C. § 102(a)(1) is not implicated in this appeal because the Examiner
is not relying on Riley’s issue date. None of the applications from which
Riley issued appear to have been published before Riley issued.
9 Riley names inventors different from those named in the application on
appeal.
10 US Provisional Application 61/501,472, filed June 27, 2011.
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pursuant to 35 U.S.C. § 119(e) and 35 U.S.C. § 120, the present application
is a continuation-in-part of US Application 13/340,120, filed December 29,
2011 (“ʼ120 application”), which claims the effective filing date of US
Provisional Application 61/429,058, filed December 31, 2010 (“ʼ058
application”). See Appeal Br. 4; see also Spec. 1 (setting forth priority
information). Appellant contends that Riley is not available as prior art
against the claims of the present application because the claims of the
present application are entitled to the earlier effective filing date of the ʼ058
application. Appeal Br. 4.
A claim in an patent application is entitled to the effective filing date
of an earlier provisional or regular patent application only if the subject
matter of the claim is “disclosed in the manner provided by” 35 U.S.C.
§ 112(a). 35 U.S.C. § 119(e); 35 U.S.C. § 120. That is, the claim is entitled
to the filing date of the earlier application only if the earlier application
provides “adequate support,” in that it includes an adequate written
description of the subject matter of the claim. Vas-Cath Inc. v. Mahurkar,
935 F.2d 1555, 1560 (Fed. Cir. 1991). The test for whether a written
description of the subject matter of a claim is adequate is whether “the
specification [of the earlier application] describe[s] an invention
understandable to that skilled artisan and show[s] that the inventor actually
invented the invention claimed.” Ariad Pharmas., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010).
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We limit our analysis to the particular limitation the Examiner
contends that the earlier application fails to describe. In re Wertheim, 541
F.2d 257, 262 (CCPA 1976) (“In our view, it is necessary to decide only
whether the [earlier application] complies with the description requirement
of § 112 with respect to the questioned limitations.”). The Examiner finds
that the ʼ058 application fails to describe the step of “continuously
monitoring changes in the one or more functional parameters while the
delivery of the interventional therapy is performed to evaluate the
interventional therapy” (the continuously monitoring step). Final Act. 9.
Consequently, the determinative issue in this appeal is whether the
ʼ058 application adequately describes the continuously monitoring step.

Claim Interpretation
Before addressing whether the ʼ058 application provides an adequate
written description of the continuously monitoring step, we construe that
step.
The Examiner interprets this step “to mean that monitoring is
performed while therapy is commencing, until the measurements indicate
that the therapy should stop[, as] opposed to performing therapy, stopping
therapy to monitor, and then performing additional therapy as is done in
Riley.” Ans. 5. The Examiner clarifies this interpretation by explaining that
Figures 18–22 of the [ʼ058] application each show step 42
“Delivery of Therapy” or step 120 “Perform additional Therapy
if Needed” as separate steps from the assessment/monitoring
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steps. It can be seen that no monitoring is done during the
delivery of therapy step.
Ans. 6; see also Final Act. 10. In other words, the Examiner interprets that
the continuously monitoring step requires the one or more functional
parameters be monitored while therapy is being delivered.
The Specification indicates that the continuously monitoring step
means obtaining functional measurements between bouts of interventional
therapy. Specifically, the Specification describes that “the sensing device
can be used to obtain functional measurements between bouts of
interventional therapy.” Spec. 10:3–5. The Examiner has not identified, nor
do we discern, any disclosure in the Specification that the sensing device
obtains functional measurements while therapy is being delivered.
Pages 25–27 of the Specification, read in view of Figures 18–22,
discuss particular embodiments of therapeutic methods for treating venous
flow obstructions. In each of these embodiments, the success of a bout of
therapy is assessed in a method step that follows the step of delivering the
therapy. For example, in describing the embodiment depicted in Figure 19,
the Specification teaches performing the step of assessing the pressure
gradient across a stenosis “after step 42,” that is, the step of delivering
therapy, “has completed.” Spec. 25:16–19. Likewise, the Specification
teaches that the method depicted in Figure 20 assesses the nature of the
treatment site “post-therapy” to determine whether the treatment has
succeeded. Spec. 25:27–26:4.
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Therefore, the step of “continuously monitoring changes in the one or
more functional parameters while the delivery of the interventional therapy
is performed to evaluate the interventional therapy,” as recited in claim 1,
means obtaining functional measurements between bouts of interventional
therapy. With this interpretation in mind we analyze the written description
requirement.

Written Description
The Examiner finds that the ʼ058 application fails to describe the
continuously monitoring step. Final Act. 9. Appellant contends that this
step is described on page 32, lines 7–20, of the ʼ058 application:
In addition, if the therapy of step 42 was not sufficient to provide
the desired blood flow or the desired reduction of the stenosis, in
an additional embodiment of the therapeutic method 30,
additional therapy of any of the types described above may be
applied as shown in Figure 21. As mentioned above, the desired
reduction of the stenosis is such that the residual stenosis is less
than 75% of the normal proximal diameter of the stenotic vein or
that a pressure gradient exceeding 1mm Hg is no longer
observed. In this embodiment of the therapeutic method 30,
additional therapy will be performed if these therapy goals are
not observed. Consequently, in this embodiment of the
therapeutic method 30, if the therapy goals are not met, the
program passes from step 42 to step 120 where step 120 is the
application of an additional therapy. The therapy of step 120
may be either the reapplication of the same therapy that was
applied in step 42 or the application of an entirely new therapy
of the types described above. In this embodiment of the
therapeutic method 30, steps 114, 116 may also be applied as
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described in connection with step 42, or applied singly or in
combination to step 120.
Appeal Br. 5. This description is carried over into paragraph 90 of the ʼ120
application and onto page 26 of the current Specification.
The quoted passage describes an embodiment of the continuously
monitoring step. The pressure gradient in the vicinity of a thrombus is a
functional parameter within the scope and meaning of that term as used in
claim 1 and the Specification. See Appeal Br. 7 (claim 2); Spec. 3. The
quoted passage, when read in view of Figure 21 of the ʼ058 application
(which also carried through the ʼ120 application and the current
Specification), teaches delivering therapy in step 42; assessing the therapy in
view of the pressure gradient; and then reapplying the same therapy or a
different therapy in step 120. The passage also teaches assessing the success
of the therapy reapplied in step 120 by applying step 116 (assessing pressure
gradient across a stenosis post-therapy to determine whether adequate blood
flow is present) to step 120. See Spec. 31:10–15 (identifying step 116 in the
method depicted in Figure 19). As Appellant points out, this passage
describes performing the delivery of therapy and the assessment of the
success of that therapy in combination with one another. Appeal Br. 5.
From the viewpoint of one of ordinary skill in the art, these teachings
describe “continuously monitoring changes in the one or more functional
parameters while the delivery of the interventional therapy is performed to
evaluate the interventional therapy,” under a proper interpretation of that
step.
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The Examiner relies on three findings to support the determination
that the ʼ058 application fails to describe the recited step. First, the
Examiner finds that “the language in the claim is not used in the provisional
disclosure.” Ans. 6. This finding is not persuasive because the law does not
require the ʼ058 application to recite the language of claim 1 in haec verba
to provide an adequate written description of the claimed subject matter.
Ariad Pharmas., 598 F.3d at 1352. Second, the Examiner finds that the ʼ058
application does not describe monitoring the one or more functional
parameters while therapy is being delivered. Ans. 6. Claim 1, as properly
interpreted, does not require this. Third, the Examiner finds that page 32,
lines 7–20, of the ʼ058 application does not explicitly describe repeating the
steps of delivering therapy and assessing the results of the therapy more than
once. Ans. 6–7. If the method described on page 32, lines 7–20, of the ʼ058
application stops after step 120, or after an additional iteration of step 114
applied to the delivery of therapy in step 120, then the functional parameter,
namely, the pressure drop, will be monitored continuously throughout the
entire time window from when treatment is first performed in step 42 to
when treatment is finally ended after step 120.
We note that the ʼ058 application describes one or more embodiments
of the recited step, but not the recited method itself. Nevertheless:
A claim will not be invalidated on section 112 grounds simply
because the embodiments in the specification do not contain
examples explicitly covering the full scope of the claim language
. . . . That is because the patent specification is written for a
person of skill in the art, and such a person comes to the patent
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with the knowledge of what has come before . . . . Placed in that
context, it is unnecessary to spell out every detail of the invention
in the specification; only enough must be included to convince a
person of skill in the art that the inventor possessed the invention.
LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345
(Fed. Cir. 2005) (citations omitted). The Examiner has not made sufficient
findings to demonstrate that the one or more embodiments described in the
ʼ058 application would have been inadequate to convey the step of
“continuously monitoring changes in the one or more functional parameters
while the delivery of the interventional therapy is performed to evaluate the
interventional therapy,” as recited in claim 1, to one of ordinary skill in the
art. Therefore, we find that the ʼ058 application describes this step.
The Examiner has not shown by a preponderance of the evidence that
Riley is prior art available for use in rejecting in dependent claim 1. Given
that each of the rejections rely on Riley, we do not sustain any of the
rejections.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–4, 7–14,
17, 19–21
103 Riley, Liu, Millar 1–4, 7–14,
17, 19–21
5, 15 103 Riley, Liu, Millar,
Mauch
5, 15
6, 16 103 Riley, Liu, Millar,
Cragg
6, 16
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Overall
Outcome
1–17, 19–
21

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

REVERSED