Michael Gloss et al.

Patent Trials and Appeals Board

Jul 2, 2020

2018007598 (P.T.A.B. Jul. 2, 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.
15/162,909 05/24/2016 Michael Gloss C00005661.USC7 1000
28390 7590 07/02/2020
MEDTRONIC VASCULAR, INC.
IP LEGAL DEPARTMENT
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
EXAMINER
BARIA, DINAH N
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
07/02/2020 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):
rs.patents.five@medtronic.com
rs.vasciplegal@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL GLOSS, TIMOTHY GROEN,
CAROLYN MAJKRZAK, MATTHEW RUST, TIMOTHY RYAN, and
MATTHEW WESTON
Appeal 2018-0075981
Application 15/162,909
Technology Center 3700

Before DANIEL S. SONG, RICHARD H. MARSCHALL, and
ALYSSA A. FINAMORE, Administrative Patent Judges.
FINAMORE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 1–11, 14, and 16–21. We have
jurisdiction under 35 U.S.C. § 6(b). We REVERSE.

1 The citations herein refer to the Specification filed May 24, 2016 (“Spec.”),
Final Office Action mailed September 5, 2017 (“Final Act.”), Appeal Brief
filed February 5, 2018 (“Appeal Br.”), Examiner’s Answer mailed May 17,
2018 (“Ans.”), and Reply Brief filed July 17, 2018 (“Reply Br.”).
2 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant
identifies the real parties in interest as Medtronic, Inc. and its parent entity,
Medtronic plc. Appeal Br. 2.
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Application 15/162,909

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SUBJECT MATTER ON APPEAL
The invention relates to prosthetic heart valves. Spec. ¶ 2. Claims 1
and 19 are independent. Appeal Br., Claims App. Independent claim 1,
reproduced below, is illustrative of the claimed subject matter.
1. A valve prosthesis comprising:
an expandable frame comprising an outflow portion and
an inflow portion connected to the outflow portion,
the frame having a longitudinal axis and defining a
central lumen extending between the outflow
portion and the inflow portion, wherein the frame is
generally cylindrical in a fully expanded
configuration,
wherein, when the frame is in a fully expanded
configuration, (i) an outer surface of the inflow
portion is concave, (ii) the inflow portion has an
upper inflow portion defining an upper edge, a
lower inflow portion defining a lower edge, and a
waist between the upper edge and the lower edge,
(iii) the upper inflow portion flares outwardly from
the longitudinal axis and the central lumen of the
frame to greater extent than the lower inflow
portion, (iv) a transverse distance from the upper
inflow portion to the longitudinal axis of the frame
increases from the waist to the upper edge, and (v) a
transverse distance from the lower inflow portion to
the longitudinal axis of the frame increases from the
waist to the lower edge,
wherein the outflow portion comprises (i) an undulating
upper outflow portion having peaks and valleys,
(ii) an undulating middle outflow portion having
peaks and valleys, and (iii) an undulating lower
outflow portion having peaks and valleys, wherein
the valleys of the undulating upper outflow portion
are connected to the peaks of the undulating middle
inflow portion, and wherein the valleys of the
undulating middle outflow portion are connected to
the peaks of the undulating lower outflow portion,
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wherein the valleys of the undulating lower outflow
portion are connected to the inflow portion along
the waist via posts.
Id. (claim status identifier and underlining omitted).

REJECTIONS
Claims
Rejected 35 U.S.C. § References/Basis 
20, 21 112(a) Written Description
1–9, 14, 16–21 102(a)(1) Essinger ’1573
1–4, 8–11, 14, 16–18, 21 102(a)(1) Essinger ’3984

ANALYSIS
Written Description
Claim 20 recites “a transverse distance from the upper portion to the
longitudinal axis of the frame continuously increases from the waist to the
upper edge” and “a transverse distance from the lower portion to the
longitudinal axis of the frame continuously increases from the waist to the
lower edge.” Appeal Br., Claims App. (emphasis added). Claim 21
similarly recites “the transverse distance from the upper inflow portion to the
longitudinal axis of the frame continuously increases from the waist to the
upper edge” and “the transverse distance from the lower inflow portion to

3 Essinger et al., US 2011/0022157 A1, pub. Jan. 27, 2011
(“Essinger ’157”).
4 Essinger et al., US 2012/0271398 A1, pub. Oct. 25, 2012
(“Essinger ’398”).

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the longitudinal axis of the frame continuously increases from the waist to
the lower edge.” Id. (emphasis added).
The Examiner finds claims 20 and 21 lack written description support
because the originally-filed disclosure does not describe that the recited
transverse distances continuously increase. Final Act. 3. The Examiner
acknowledges Figure 6 shows that the recited transverse distances increase,
but finds one of ordinary skill would not be able to ascertain from the figures
whether the change is continuous. Id.; Ans. 18. According to the Examiner
“the term ‘continuously’ brings in the parameter of rate/pitch, which is
clearly NOT disclosed or taught in the originally[-]filed disclosure of the
current application.” Ans. 18 (emphasis in original).
On the other hand, Appellant argues Figure 6 shows the recited
transverse distances continuously increasing in that the upper inflow portion
and the lower inflow portion only extend farther away from the longitudinal
axis when traveling from the waist to the corresponding edge, and do not
extend back toward the longitudinal axis. Appeal Br. 30; see also Reply
Br. 15 (“[T]he transverse distance does not decease at any point moving
from the waist to the upper/lower edge.” (emphasis omitted)). Per
Appellant, “the term ‘continuously’ does not suggest that a rate/pitch is
constant, but rather that the rate/pitch exists and is always extending in the
same direction.” Reply Br. 15.
At the center of this dispute is the meaning of the claim term
“continuously.” When construing claims,
the PTO applies to the verbiage of the proposed claims the
broadest reasonable meaning of the words in their ordinary usage
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as they would be understood by one of ordinary skill in the art,
taking into account whatever enlightenment by way of
definitions or otherwise that may be afforded by the written
description contained in applicant’s specification.
In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). If the specification does
not assign or suggest a particular definition to a claim term, it is appropriate
to consult a general dictionary definition of the term for guidance in
determining the ordinary and customary meaning of the claim term as
viewed by a person of ordinary skill in the art. Comaper Corp. v. Antec,
Inc., 596 F.3d 1343, 1348 (Fed. Cir. 2010).
“Continuous” ordinarily means “[u]ninterrupted in time, sequence,
substance, or extent.” Continuous, American Heritage Dictionary of the
English Language (5th ed. 2016), https://www.thefreedictionary.com/
continuous (last visited June 28, 2020). Appellant’s Specification does not
include the word “continuous” or any form thereof. Nonetheless, the
Specification describes, with reference to Figures 6–9, that the upper and
lower inflow portions flare outwardly from the longitudinal axis of the
frame. Spec. ¶¶ 39–41. As shown in at least Figure 6, the transverse
distance from the upper portion to the longitudinal axis increases, without
interruption, when moving from the waist to the upper edge, and the
transverse distance from the lower portion to the longitudinal axis always
increases when moving from the waist to the lower edge. Thus, the ordinary
meaning of “continuous” is consistent with the Specification’s description of
how the transverse distances increase.
In accordance with the broadest reasonable interpretation,
“continuous” encompasses “uninterrupted,” such that the claim term
“continuously increases” covers an uninterrupted increase, such as the
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uninterrupted increase in the transverse distances shown in Figure 6. As
Figure 6 shows that the transverse distance from the upper portion to the
longitudinal axis of the frame continuously increases from the waist to the
upper edge, and that the transverse distance from the lower portion to the
longitudinal axis continuously increases from the waist to the lower edge,
the Examiner has not demonstrated persuasively that claims 20 and 21 lack
written description support. We, therefore, do not sustain the rejection of
claims 20 and 21.

Anticipation Based on Essinger ’157
In rejecting independent claim 1, the Examiner relies on certain
figures of Essinger ’157. Final Act. 4–6. The Examiner finds the recited
frame and inflow portion are shown in Figure 1A. Id. at 4–5. The Examiner
further finds Figure 7 shows the recited outflow portion, including the
undulating upper, middle, and lower portions thereof. Id. at 5–6. The
Examiner also finds the recited posts are shown in Figure 4. Id. at 6.
In rejecting independent claim 19, the Examiner likewise relies on
certain figures of Essinger ’157. Id. at 9–10. The Examiner finds Figure 5
shows the recited frame, as well as the recited inflow portion including a
plurality of closed cells. Id. The Examiner also finds Figures 7 and 4 show
the recited outflow portion and posts, similar to the rejection of independent
claim 1. Id.
Appellant argues the Examiner relies on separate and distinct
embodiments of Essinger ’157 to reject each of independent claims 1 and 19,
and has not shown Essinger ’157 discloses all of the claim elements as
arranged in the claim, as anticipation requires. Appeal Br. 10–18; Reply
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Br. 2–4. According to Appellant, Essinger ’157 does not describe any
interrelation between Figures 1A, 4, and 7, and Figures 4 and 7 show
embodiments that are different than that shown in Figure 1A. Appeal
Br. 11; Reply Br. 3–4.
In response, the Examiner explains:
Separate embodiments were not used together to make the
rejection of claims 1 and 19; instead the rejections depend on one
embodiment, as illustrated in Figure 7, and other figures were
used for illustrative purposes, to make it easier to see/point out
features of the inflow portion which are part of the embodiment
of Figure 7, however not as clearly illustrated in the figure.
Ans. 15. The Examiner also provides an annotated version of Figure 7,
reproduced below, identifying the features the Examiner originally identified
in Figure 7, as well as the features the Examiner originally identified in
Figures 1A, 4, and 5. Ans. 5.
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Figure 7 shows the stent component in an expanded configuration.
Essinger ’157 ¶ 31. The Examiner annotated the figure to label the inflow
portion as “IP.” The Examiner identifies the waist of the inflow portion, and
labels the closed cells of the inflow portion as “CC.” The Examiner also
labels the upper, middle, and lower outflow portions as “UOP,” “MOP,” and
“LOP,” respectively. The Examiner respectively labels the peaks of the
upper, middle, and lower outflow portions as “PU,” “PM,” and “PL,” and
similarly labels the valleys of the upper, middle, and lower outflow portions
as “VU,” “VM,” and “VL,” respectively. The Examiner also magnifies a
juncture of the inflow portion and a valley of the lower outflow portion and,
at this magnified juncture, adds lines to delineate the inflow portion and
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lower outflow portion and identifies a post, which the Examiner labels as
“P.”
Even if the Examiner’s finding of anticipation relies on a single
embodiment, namely the embodiment shown in Figure 7, we agree with
Appellant that the Examiner has not demonstrated persuasively that this
embodiment discloses “an undulating middle outflow portion having peaks
and valleys,” as recited in independent claims 1 and 19. In finding the
embodiment shown in Figure 7 discloses this limitation, the Examiner
explains: “According to the Oxford Dictionary the definition of the word
‘undulate’ is ‘move or go with a smooth up and down motion.’” Ans. 16.
The Examiner finds the recited undulating middle outflow portion is shown
in Figure 7, and the Examiner provides an annotated version of a portion of
Figure 7, reproduced below, identifying the undulating middle outflow
portion. Id.

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The Examiner’s annotated version of Figure 7 shows the middle portion of
the figure, thereby depicting the middle of the expanded stent, which
includes a bifurcated circular structure. The Examiner annotated the figure
to identify the bifurcated circular structure as the middle outflow portion
(“MOP”). To show that the middle outflow portion undulates, the Examiner
further annotated the figure to include a line that begins at the bottom of the
bifurcated circular structure, extends up the left side, goes down the middle
portion, extends up the right side, and ends at the top of the bifurcated
circular structure. The Examiner also annotated the figure to identify the
portion of the line near the top of the bifurcated circular structure as a peak
of the undulating middle outflow portion (“PM”) and the portion of the line
near the bottom of the bifurcated circular structure as a valley of the
undulating middle outflow portion (“VM”).
The dispositive question regarding anticipation is whether one skilled
in the art would reasonably understand or infer that the prior art discloses the
claimed invention. Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d
1358, 1368 (Fed. Cir. 2003). Regardless of whether the line the Examiner
added to the bifurcated circular structure undulates, the bifurcated circular
structure itself does not. Absent the Examiner’s line, the portions near the
top and bottom of the bifurcated circular structure that the Examiner
identifies as the peak and valley, respectively, appear to be the top of a
bottom of a circle, which has no peaks or valleys. As the alleged undulation
and the peaks and valleys are apparent only with the Examiner’s line, which
is not part of Figure 7 or otherwise described in Essinger ’157, the Examiner
has not demonstrated persuasively that a person of ordinary skill in the art
would have understood that the embodiment shown in Figure 7 discloses “an
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undulating middle outflow portion having peaks and valleys,” as recited in
independent claims 1 and 19. We, therefore, do not sustain the rejection of
independent claims 1 and 19 and claims 2–8, 14, 16–18, 20, and 21
depending therefrom.

Anticipation Based on Essinger ’398
The anticipation rejection premised on Essinger ’398 suffers from a
similar deficiency as the anticipation rejection based on Essinger ’157. The
Examiner finds Figure 2I of Essinger ’398 discloses “an undulating middle
outflow portion having peaks and valleys,” as recited in independent
claim 1. Final Act. 12–13; Ans. 16. The Examiner provides an annotated
version of a portion of Figure 2I, reproduced below, identifying the
undulating middle outflow portion. Ans. 16.

The Examiner’s annotated version of Figure 2I shows the middle portion of
the figure, which depicts the middle of the expanded stent including a
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bifurcated dome-shaped structure. The Examiner annotated the figure to
identify the bifurcated dome-shaped structure as the middle outflow portion
(“MOP”). To show that the middle outflow portion undulates, the Examiner
further annotated the figure to include a line that begins at the bottom of the
bifurcated dome-shaped structure, extends up the left side, goes down the
middle portion, extends up the right side, and ends at the top. The Examiner
also annotated the figure to identify the portion of the line near the top of the
bifurcated dome-shaped structure as a peak of the undulating middle outflow
portion (“PM”) and the portion of the line near the bottom of the bifurcated
dome-shaped structure as a valley of the undulating middle outflow portion
(“VM”).
Irrespective of whether the line the Examiner added to the bifurcated
dome-shaped structure undulates, the bifurcated dome-shaped structure itself
does not. Absent the Examiner’s line, the identified peak appears to be the
top of a dome, which is devoid of peaks, and the identified valley appears to
the bottom a rectangle, which has no valleys. As the alleged undulation and
the peaks and valleys are evident only with the Examiner’s line, which is not
part of Figure 2I or otherwise described in Essinger ’398, the Examiner has
not demonstrated persuasively that a person of ordinary skill in the art would
have understood that Figure 2I discloses “an undulating middle outflow
portion having peaks and valleys” recited in independent claim 1. We,
therefore, do not sustain the rejection of independent claim 1 and
claims 2–4, 8–11, 14, 16–18, and 21 depending therefrom.

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CONCLUSION
We do not sustain the rejection of claims 20 and 21 under 35 U.S.C.
§ 112(a) for failing to comply with the written description requirement. We
also do not sustain the rejection of claims 1–9, 14, and 16–21 under 35
U.S.C. § 102(a)(1) as anticipated by Essinger ’157 or the rejection of
claims 1–4, 8–11, 14, 16–18, and 21 under 35 U.S.C. § 102(a)(1) as
anticipated by Essinger ’398.

DECISION SUMMARY
Claims
Rejected 35 U.S.C. § Reference(s)/Basis  Affirmed Reversed
20, 21 112(a) Written Description 20, 21
1–9, 14,
16–21 102(a)(1) Essinger ’157
1–9, 14,
16–21
1–4, 8–11,
14, 16–18,
21
102(a)(1) Essinger ’398
1–4, 8–11,
14, 16–18,
21
Overall
Outcome:  
1–11, 14,
16–21

REVERSED