Volcano Corporation

Patent Trials and Appeals Board

Dec 15, 2020

2020003023 (P.T.A.B. Dec. 15, 2020)

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.
14/133,331 12/18/2013 Bret C. Millett 2012P02346US01 8744
24737 7590 12/15/2020
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus Avenue
Suite 340
Valhalla, NY 10595
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
12/15/2020 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 BRET C. MILLETT and PAUL DOUGLAS CORL

Appeal 2020-003023
Application 14/133,331
Technology Center 3700
____________

Before MURRIEL E. CRAWFORD, PHILIP J. HOFFMANN, and
KENNETH G. SCHOPFER, Administrative Patent Judges.

SCHOPFER, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–3, 6–9, 11–16, 20, and 22–26. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

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
Koninklijke Philips N.V. Appeal Br. 3.
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BACKGROUND
The Specification discloses, “[t]he present disclosure relates to
intravascular devices, systems, and methods. In some embodiments, the
intravascular devices are guide-wires that include one or more sensing
components and memory storing information about the guide-wire. In some
embodiments, the intravascular devices are guide-wires that include wireless
communication functionality.” Spec. ¶ 2.

CLAIMS
Claims 1 and 7 are the independent claims on appeal. Claim 1 is
illustrative of the appealed claims and recites:
1. A pressure sensing guide-wire, comprising:
an elongate flexible element comprising a proximal
portion and a distal portion configured to be positioned within a
blood vessel of a patient, the elongate flexible element
comprising an outer diameter of 0.018" or less, wherein the
elongate flexible element comprises a space surrounded by the
outer diameter and a core wire disposed within the space;
a pressure sensing component coupled to the distal portion
of the elongate flexible element;
a sensor control module coupled to the distal portion of the
elongate flexible element;
a data storage module coupled to the distal portion of the
elongate flexible element, wherein the data storage module is in
communication with the sensor control module, the data storage
module comprising a memory configured to store identification
information about the pressure sensing component, wherein the
memory is integrated in the distal portion of the elongate flexible
element; and
an antenna coupled to the distal portion of the elongate
flexible element, the antenna
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configured to transmit the identification information about the
pressure sensing component to a processing system to validate
the pressure sensing component based on the transmitted
identification information, receive sensor output from the sensor
control module, and transmit the sensor output from the distal
portion of the elongate flexible element to the processing system
after validation of the pressure sensing component,
wherein the pressure sensing component, the sensor
control module, the data storage module, and the antenna are
disposed within the space surrounded by the outer diameter of
the elongate flexible element such that the pressure sensing
component, the sensor control module, the data storage module,
and the antenna are configured to be positioned within the blood
vessel when the distal portion of the elongate flexible element is
positioned within the blood vessel.
Appeal Br. 23–24.
REJECTIONS2
1. The Examiner rejects claims 1, 6, 7, 11, 12, 14–16, 20, 22, 23, 25, and 26
under 35 U.S.C. § 103(a) as unpatentable over Tulkki ’1443 in view of
Thornton,4 and Hossack,5 as evidenced by IDTechEx.6
2. The Examiner rejects claims 2, 3, 8, 9, 13, and 24 under 35 U.S.C.
§ 103(a) as unpatentable over Tulkki ’144 in view of Thornton, Hossack,
and Tulkki ’165.7

2 The Examiner has withdrawn the rejection under 35 U.S.C. § 112. Ans. 3.
3 Tulkki et al., US 2007/0255144 A1, pub. Nov. 1, 2007.
4 Thornton et al., US 2010/0305476 A1, pub. Dec. 2, 2010.
5 Hossack et al., US 2007/0083111 A1, pub. Apr. 12, 2007.
6 “Basic components of an RFID system,” IDTechEx Aug. 19, 2004.
7 Tulkki, US 2007/0106165 A1, pub. May 10, 2007.
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DISCUSSION
Claims 1, 6, 20, 22, 23, 25, and 26
Appellant addresses claims 1, 6, 20, 22, 23, 25, and 26 as a group.
See Appeal Br. 11. We select claim 1 as representative of this group of
claims, and claims 6, 20, 22, 23, 25, and 26 will stand or fall with claim 1.
See 37 C.F.R. § 41.37(c)(1)(iv).
With respect to claim 1, the Examiner finds that Tulkki ’144 teaches a
pressure sensing guidewire including a core wire, a pressure sensing
component coupled to the distal end of the core wire, a sensor control
module coupled to the distal end of the wire, a data storage module coupled
to the distal end of the core wire, and an antenna coupled to the distal end of
the core wire. Final Act. 5–6 (citing Tulkki ’144 Fig. 9; ¶¶ 33, 35–37, 39,
42). The Examiner acknowledges that Tulkki ’144 does not expressly
disclose that the core wire, pressure sensing component, sensor control
module, data storage module, and antenna are disposed within “a space
surrounded by the outer diameter” of an elongate flexible element. Id. at 7.
However, the Examiner finds that Tulkki ’144 teaches that
conventional guidewire devices include electronic components and a core
wire disposed within the space defined by elongate flexible elements, and at
least suggests that “the core wire and elongate flexible element are
sufficiently coupled to prevent movement relative to each other and maintain
the sensing element in the desired position adjacent” an aperture in the
flexible element. Id. (citing Tulkki ’144 Fig. 1; ¶¶ 3, 29). The Examiner
then determines:
it would have been obvious to one of ordinary skill in the art at
the time of the invention to further modify the guidewire of
Tulkki ’144 with such an elongate flexible portion in which the
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core wire and electronic components (e.g., pressure sensing
component, sensor control module, data storage or memory
module, antenna, etc.) are disposed and coupled in order to house
and/or protect the electronic components from physical damage
and to appropriately size the guidewire device for intravascular
use (Tulkki ’144, ¶ [0003]).
Id. at 7–8. The Examiner also further explains that providing these
components within the elongate flexible member would provide predictable
benefits, “such as better protecting electronic components . . . [and]
providing a smoother guidewire profile for easier/less traumatic
manipulation through the vasculature.” Ans. 5.
Additionally, to the extent Tulkki ’144 does not teach that the data
storage module is integrated in the distal portion of the device, the Examiner
relies on Thornton to address this deficiency. Final Act. at 6. Finally, the
Examiner relies on Hossack to show that it would have been obvious to
further modify Tulkki ’144 such that the data storage module is “configured
to store ID information about the pressure sensing component” as required
by the claim. Id. at 8–9.
We agree with and adopt the Examiner’s findings and conclusions
with respect to the rejection of claim 1. See Final Act. 5–9; see also Ans. 3–
6. As discussed below, we are not persuaded of error by Appellant’s
arguments.
Appellant first argues that the prior art of record does not disclose
each of a pressure sensing element, sensor control module, data storage
module, and antenna “disposed within the space surrounded by the outer
diameter of the elongate flexible element” as required by claim 1. Appeal
Br. 13–14. With respect to the Examiner’s reliance on Tulkki ’144 for this
requirement, Appellant asserts that Tulkki ’144 only describes the prior art
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device as including a sensor that is disposed within an elongate flexible
element and that, Tulkki ’144 distinguishes this from Tulkki ’144’s “present
invention” depicted in Figure 7, which shows that the sensor assembly is
located outside the outer diameter of the elongate flexible element. Id. at 14.
We are not persuaded. First, we note that the rejection does not rely
on any express teaching from Tulkki ’144 that the pressure sensing
component, sensor control module, data storage module, and antenna are
disposed within the interior space of the elongate flexible element. Rather,
the Examiner finds that disposing these elements within the elongate flexible
element would have been obvious for various reasons including to protect
the components and the patient from physical damage. See Final Act. 7–8.
Second, we are not persuaded that Tulkki ’144’s “present invention”
is expressly described as including such components on the outside of the
flexible element. With respect to this assertion, Appellant relies on the
depiction provided in Tulkki ’144 Figure 7. Appeal Br. 14–15. Although
this Figure might appear to show the sensor assembly 73 located outside of
the elongate flexible element, the Figure is described as “schematically”
showing the use of the Tulkki ’144’s guidewire 71. We do not interpret such
a schematic as necessarily showing the exact structural relationship between
the sensor assembly and the distal end of the guidewire. Further, we agree
with the Examiner that Tulkki ’144 discloses, with respect to Figure 7, that
the core wire “serves as the support for the sensor assembly.” Ans. 5 (citing
Tulkki ’144 ¶ 37). Appellant notes that, with respect to the prior art,
Tulkki ’144 discloses a sensor mounted on the core wire, which is different
than Tulkki ’144’s disclosure that the core wire supports the sensor assembly
in Figure 7. Reply Br. 4. However, we agree with the Examiner that, at the
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least, the description with respect to Figure 7 and the specific disclosure that
sensors in the prior art, as in Figure 1, are disposed within the elongate
flexible element suggests that the sensor assembly may be located within the
elongate flexible element in the embodiment depicted in Figure 7. Id.
Third, we are also not persuaded to the extent Appellant also asserts
that Tulkki ’144 “explains that there is very limited space within the outer
diameter.” Appeal Br. 15. Appellant indicates that Tulkki ’144 only
describes sensor 8 in the prior as being located within the elongate flexible
element and that the sensor assembly in Figure 7 is not located within the
elongate flexible member because of this limited space. However, we agree
with the Examiner that Tulkki ’144’s disclosure of limited space refers to
more proximal portions of the guidewire in which the core wire is not
tapered and can only accommodate certain sizes of transmitting cables. See
Tulkki ’144 ¶ 3 (“the core wire occupies a major portion of the available
space inside the flexible tube, thereby leaving a very limited space for the
signal transmitting cables. Consequently, the signal transmitting cables are
very thin, and constitute delicate and sensitive parts of the sensor and
guidewire assembly”).
Next, Appellant argues that the Examiner “has not provided a
reasonable articulated basis for combining [the art of record] in the manner
proposed,” and that the rejection thus relies on hindsight reasoning. Appeal
Br. 16 (emphasis omitted). In support, Appellant asserts that “Tulkki ‘144
itself does not support the . . . importation of various sensor assembly
features into the prior art embodiment shown in Fig 1. of Tulkki ’144.” Id.
Appellant further asserts
In that regard, Tulkki ’144, in Fig. 1, shows only the sensor 8
inside of the jacket 6. By contrast, in Fig. 7, shows the sensor
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assembly 73 outside of the guide wire 71. (See Tulkki ’144, ¶ 29;
Figs. 1, 7.) A person of ordinary skill in the art would not have
simply moved the additional components included in the sensor
assembly 73 of Fig. 7 inside of the jacket 6, based at least on the
acknowledgment in Tulkki ’144 of the very limited space within
the outer diameter, especially when the sensor assembly 73 is
illustrated outside of the guide wire 71 in Fig. 7. (Tulkki ’144,
¶ 3.) Instead, it appears that the Office has impermissibly used
“the claimed invention as an instruction manual or ‘template’ to
piece together the teaching of the prior art so that the claimed
invention is rendered obvious.”
Id. at 17 (quoting Ex Parte Hawkins, Appeal 2009-000134, p. 8 (BPAI
Sept. 14, 2009).)
We are not persuaded. As discussed above, Tulkki ’144 at least
suggests that the sensor assembly 73 and its various components may be
disposed within the elongate flexible element. Thus, we disagree with
Appellant’s assertion that the rejection relies on moving elements from
Tulkki ’144’s Figure 7 into the prior art embodiment depicted in Figure 1.
Further, the key to supporting a prima facie conclusion of obviousness under
35 U.S.C. § 103 is the clear articulation of the reason why the claimed
invention would have been obvious. The Court in KSR International Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007) indicated that the analysis supporting
a rejection under 35 U.S.C. § 103 should be made explicit. The Federal
Circuit has stated that “rejections on obviousness grounds cannot be
sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006),
cited with approval in KSR, 550 U.S. at 418. Here, the Examiner provides
sufficient articulated reasoning to support the conclusion of obviousness,
which Appellant does not address. Specifically, the Examiner determines,
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and we agree, that the proposed modification would provide predictable
benefits related to protecting the patient and the sensitive component parts of
the guide wire.
Based on the foregoing, we are not persuaded of error and we sustain
the rejection of claim 1. We also sustain the rejection of dependent claims 6,
20, 22, 23, 25, and 26, which fall with claim 1.
Claims 7, 11, 12, and 14–16
Appellant addresses claims 7, 11, 12, and 14–16 as a group. See
Appeal Br. 17. We select independent claim 7 as representative of this
group of claims, and claims 11, 12, and 14–16 will stand or fall with claim 1.
See 37 C.F.R. § 41.37(c)(1)(iv). We agree with and adopt the Examiner’s
findings and analysis with respect to claim 7. See Final Act. 9–14; Ans. 7–8.
We are not persuaded of error by Appellant’s arguments with respect to
claim 7.
First, to the extent Appellant argues that the rejection of this claim is
in error for the same reasons as claim 1, we disagree for the reasons
discussed above.
Second, with respect to claim 7 in particular, Appellant asserts that “in
claim 7, the processing system wirelessly receives, from the antenna, both
(1) identification information, and (2) sensor output from the pressure
sensing component.” Appeal Br. 18 (emphasis omitted). Appellant also
asserts that the rejection relies on Hossack to teach these features, and
Appellant argues that the Examiner “has not identified any disclosure in
Hossack that discloses or suggests a processing system that receives sensor
output, in addition to identification information, wireless via an interface.”
Id. (emphasis omitted).
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We are not persuaded for the reasons provided by the Examiner. See
Ans. 7–8; Final Act. 8–9 (citing Hossack Abstract; ¶¶ 9, 11, 13; Fig. 1).
Specifically, the Examiner explains that the rejection relies on Tulkki ’144
for the required wireless hardware including an antenna and that Hossack is
relied on for further functionality by teaching an “antenna [that] is
configured to transmit identification information about a sensing component
to a processing component that is configured to receive said identification
information and to validate the sensing component based on the
identification information,” which “provides the benefit(s) of allowing the
processing system to select appropriate analysis algorithms and/or
software . . . and/or prohibiting use of a component that has surpassed its
permissible hours or times of use.” Ans. 7; see also Final Act. 8–9.
Appellant’s argument in the Appeal Brief does not specifically address any
deficiency in the Examiner’s findings or analysis.
In the Reply Brief, Appellant argues that “Tulkki ’144 and Hossack
do not disclose or suggest the system including the pressure sensing guide-
wire and processing system configured to operate in the interdependent
manner recited in claim 7.” Reply Br. 7. Specifically, Appellant asserts:
In this regard, the cited portions of Hossack report determining
whether or not to permit catheter operation based on security
information stored on an RFID chip. (Hossack, ¶ 13). The cited
portions of Tulkki ’144 only report that a signal from a sensor
may be transmitted wirelessly using a magnetically coupled
resonant circuit. (Tulkki ’144, [¶¶] 35–36.) No portions have
been identified in Hossack or Tulkki ’144 that would disclose or
suggest the system of claim 7 in which the pressure sensing
guide-wire cooperates with the processing system to validate the
pressure sensing component and wirelessly receive the sensor
output from the validated pressure sensing component.
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Id. We are not persuaded. Notably, the rejection does not rely on either
Tulkki ’144 or Hossack to specifically teach a processing system that
validates a pressure sensing component. Rather, the Examiner determines
that validating the pressure sensor component in Tulkki ’144 would have
been obvious in light of Hossack’s disclosure of validating certain
operational characteristics of a catheter. Final Act. 8–9. The Examiner
determines that it would have been obvious to modify Tulkki ’144 based on
Hossack’s teachings in order to, for example, limit the use of the guidewire
when the pressure sensing component “surpasses its permissible hours or
times of use.” Id. at 9 (citing Hossack ¶ 13). Appellant’s argument does not
persuade us of error in this determination.
Based on the foregoing, we are not persuaded of error in the rejection
of claim 7, and thus, we sustain this rejection. We also sustain the rejection
of claims 11, 12, and 14–16, which fall with claim 7.
Claims 2, 3, 8, 9, and 13
With respect to the rejection of claims 2, 3, 8, 9, and 13, Appellant
argues only that the rejection fails to address the deficiencies in the rejection
of claims 1 and 7. Appeal Br. 8. Having found no deficiencies as discussed
above, we are also not persuaded of error in the rejection of claims 2, 3, 8, 9,
and 13. Accordingly, we sustain the rejection of claims 2, 3, 8, 9, and 13.
Claim 24
Claim 24 depends from claim 1 and further recites:
wherein the sensor control module uses calibration information
specific to the pressure sensing component to normalize sensor
output from the pressure sensing component, wherein the
antenna is configured to receive the normalized sensor output
from the sensor control module, and transmit the normalized
sensor output from the distal portion of the elongate flexible
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element to the processing system after validation of the pressure
sensing component.
Appeal Br. 28.
We agree with and adopt the Examiner’s findings and analysis with
respect to claim 24. See Final Act. 17–18; Ans. 8–10. As discussed below
we are not persuaded of error in the rejection of this claim.
Appellant first argues:
No portions have been identified in Tulkki ’165 that disclose or
suggest that the sensor signal adapting circuitry or the calibration
unit is/are disposed in a space within a distal portion of an
elongate flexible member such that a sensor output is both (1)
normalized within, and (2) transmitted from the space in the
distal portion while the sensing guidewire is positioned inside a
blood vessel.
Appeal Br. 20. Thus, Appellant is arguing that Tulkki ’165 also does not
disclose placing certain elements of the catheter within the space surrounded
by the outer diameter of the elongate flexible member as required by
claim 24. The rejection does not appear to rely on any teaching in
Tulkki ’165 with respect to placing elements within the distal portion of an
elongate flexible element. Rather, the Examiner proposes that Tulkki ’144 is
modified based on the teachings of Tulkki ’165, in which case, as discussed,
we agree with the Examiner’s determination regarding the obviousness of
placing components within the distal portion of the elongate flexible element
as require by claim 1. Further, in the Answer, the Examiner explains that the
rejection does not rely on incorporating any specific components from
Tulkki ’165 into Tulkki ’144, and only requires a modification of the
functionality in the components of Tulkki ’144. Ans. 7–8.
In the Reply Brief, Appellant further argues that “[a] person of skill in
the art would understand that the configuration described in Tulkki ’165 is
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not amenable to wireless transmission, which typically involves digital
signals as opposed to analog signals.” Reply Br. 9. Thus, Appellant asserts
that there would have been “no motivation to combine the teachings of
Tulkki ’165 and Tulkki ’144 in the manner proposed” by the Examiner.” Id.
We are not persuaded. This argument appears to also rely on a physical
incorporation of Tulkki ’165 components into Tulkki ’144, which is not
relied upon by the Examiner. As noted, the Examiner proposes only
modifying the functionality of existing components in Tulkki ’144 based on
the teachings of Tulkki ’165. Further, Appellant does not address the
reasoning provided by the Examiner to support the conclusion that such a
modification would have been obvious, e.g., to increase the accuracy and
reliability of measured values. Ans. 9–10.
Based on the foregoing, we are not persuaded of error and we sustain
the rejection of claim 24.
CONCLUSION
We AFFIRM the rejections of claims 1–3, 6–9, 11–16, 20, and 22–26.
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 6, 7, 11,
12, 14–16,
20, 22, 23,
25, 26
103 Tulkki ’144,
Thornton, Hossack
1, 6, 7, 11,
12, 14–16,
20, 22, 23,
25, 26

2, 3, 8, 9, 13,
24
103(a) Tulkki 144
Thornton, Hossack,
Tulkki 165
2, 3, 8, 9,
13, 24

Overall
Outcome
1–3, 6–9,
11–16, 20,
22–26

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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). See 37 C.F.R.
§ 1.136 (a)(l)(iv).

AFFIRMED