MEDTENTIA INTERNATIONAL LTD OY

Patent Trials and Appeals Board

Dec 24, 2021

2021004240 (P.T.A.B. Dec. 24, 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.
14/762,382 07/21/2015 Olli Keränen P1534US01 1157
15579 7590 12/24/2021
Patent Grove LLC
1900 Campus Commons Drive
Suite 100-40
Reston, VA 20191
EXAMINER
COLELLO, ERIN L
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
12/24/2021 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):
USPTO@dockettrak.com
helene@patentgrove.com
tomas@patentgrove.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte OLLI KERÄNEN, JANI VIRTANEN, MARK PUGH,
GER O’CARROLL, and ADRIAN MORAN
Appeal 2021-004240
Application 14/762,382
Technology Center 3700
Before BENJAMIN D. M. WOOD, JEREMY M. PLENZLER, and
BRANDON J. WARNER, Administrative Patent Judges.
WOOD, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3–8, 10, 11, and 13–16. Claims 2, 9,
12 and 17–25 have been canceled. Appeal Br. 3, 15. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.

1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42(a).
Appellant identifies the real party in interest as Medtentia International
Ltd. Oy. Appeal Br. 3.
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CLAIMED SUBJECT MATTER
The claims are directed to a medical device for selecting the size
and/or shape of a cardiac-valve annuloplasty implant. Spec. 1:15–19. Sole
independent claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A medical device for facilitating selection of a shape and/or
size of an annuloplasty implant for a patient, comprising:
a catheter with a proximal end and a distal end,
an extension member at least partly arranged inside the
catheter with an operator end and a measurement end,
wherein the measurement end of the extension member is
extendable relative from the distal end of the catheter for
apposition with a first commissure of a cardiac valve, such as a
mitral valve of the patient,
wherein a measurement related to the selection of the
annuloplasty implant’s shape and/or size is based on at least an
extended length of the measurement end of the extension
member from the distal end of the catheter, when positioned at
the cardiac valve, to the first commissure, and
wherein the measurement end of the extension member
comprises a guide adapted to catch and guide the annuloplasty
implant, the guide having a ring-shaped or c-shaped opening
sized to allow passage of the annuloplasty implant
therethrough, whereby the annuloplasty implant is implantable
through the ring-shaped or c-shaped opening of the guide at the
first commissure when the guide is in apposition with the first
commissure.

REFERENCES
Name Reference Date
Liddicoat US 2001/0049558 A1 Dec. 6, 2001
Liddicoat ’486 US 2006/0074486 A1 Apr. 6, 2006
Ryan US 2009/0192603 A1 July 30, 2009

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REJECTIONS
Claims Rejected 35 U.S.C. § References
1, 3–6, 8, 10, 11, 132 102 Liddicoat
1, 4–8, 10, 11, 13–16 103 Ryan, Liddicoat
3 103 Ryan, Liddicoat,
Liddicoat ’486
OPINION
Claims 1, 3–6, 8, 10, 11, and 13—§ 102—Liddicoat
Appellant argues claims 1, 3–6, 8, 10, and 11 as a group. Appeal Br.
4–9. We select claim 1 as representative of the group, and decide the appeal
of these claims on the basis of claim 1 alone. 37 C.F.R. § 41.37(c)(1)(iv).
Claim 13 will be addressed separately.
Claim 1
The Examiner finds that Liddicoat teaches all of the limitations of
claim 1, specifically finding that adjustable mounting ring 140 corresponds
to the claimed extension member, and ring segments 210 with grooves 260
correspond to the claimed guide having a c-shaped opening. Final Act. 3–4
(citing Liddicoat ¶¶ 3–4, 13–14, 44–45, 47–48, 51, 56, Figs. 3–7, 8–12, 21,
22).3
Appellant argues that Liddicoat does not disclose:
[W]herein
[(i)] the measurement end of the extension member comprises a
guide adapted to catch and guide the annuloplasty implant,

2 The Examiner lists claim 25 as subject to this rejection, as well as the
rejection under § 103. Final Act. 3, 7. However, claim 25 was canceled by
an October 7, 2020 Amendment after final action, which the Examiner
entered on October 29, 2020. See Advisory Act. (Oct. 29, 2020).
3 Figure 5 of Liddicoat depicts mounting ring 140 as comprising three
mounting ring segments 210. Liddicoat, Fig. 5.
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[(ii)] the guide having a ring-shaped or c-shaped opening sized
to allow passage of the annuloplasty implant therethrough,
[and (iii)] whereby the annuloplasty implant is implantable
through the ring-shaped or c-shaped opening of the guide at the
first commissure when the guide is in apposition with the first
commissure.
Appeal Br. 13 (Claims App.); see id. at 4–9. Appellant also argues that
Liddicoat does not disclose the claimed catheter. Id. at 9.
(i) the measurement end comprises a guide adapted to catch and
guide the annuloplasty implant
Appellant first argues that Liddicoat’s mounting ring 140/ring
segments 210/grooves 260 are not “adapted to catch and guide the
annuloplasty implant.” Appeal Br. 5–7. Appellant asserts that this
limitation “is understood to mean that the annuloplasty implant is ‘caught’
by the guide in order to direct the movement of the annuloplasty implant.”
Appellant bases its understanding of this limitation on the following excerpt
of the Specification:
For example, when using rings as anchors 7 the annuloplasty
implant is inserted through and slides in the rings securing the
annuloplasty implant at the commissures 5. In an example the
anchors 7 are arranged in the atrium and catch and guides an
upper part of the helix ring. . . . after the annuloplasty implant is
implanted in the patient, through the opening of the c-shape.
Id. at 5 (quoting Spec. 9:1–4, 20–21) (emphasis added by Appellant)
(internal quotation marks omitted). Appellant submits that Liddicoat teaches
that a tissue annuloplasty band is “mounted onto” and “placed into groove
260 on the adjustable mounting ring 140,” and is “guided into place, with the
tissue annuloplasty band 100 seated in place.” Id. at 7 (citing Liddicoat
¶ 47, Fig. 12) (emphasis omitted). According to Appellant, “Liddicoat’s
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disclosure that the tissue annuloplasty band ‘is mounted onto’ the ring
segments 210 is incompatible with the function of catching and guiding an
annuloplasty implant because the function of the groove 260 and the entire
mounting ring 140 is to prevent the annuloplasty implant from moving until
it is sutured to the annulus.” Id. (citing Liddicoat ¶ 13). Appellant
acknowledges that Liddicoat teaches that “[t]he implant can be guided to a
position in the body while mounted to mounting ring 140 but this is
functionality [sic] distinct from what is recited in claim 1, which is to catch
and guide the annuloplasty implant.” Id.
The Examiner responds that mounting the tissue annuloplasty band
onto the mounting ring and placing it into groove 260 means that the
grooved mounting ring segments catch the annuloplasty band, and that
guiding the mounting ring and tissue in place means that the tissue is guided;
the Examiner therefore submits that Liddicoat teaches a guide capable of
catching and guiding the implant. Ans. 4. The Examiner further contends
that the Specification does not provide a special definition for “guide the
annuloplasty implant,” and also does not provide “additional details in the
limitation ‘adapted to catch and guide the annuloplasty implant’ that [would]
require the implant to move relative to the guide or that would preclude the
implant from being mounted to the guide for a portion of the procedure.” Id.
at 4–5.
In the Reply Brief, Appellant counters that one of ordinary skill in the
art would understand the difference between “to catch” and “to mount”
based on “the difference between the commonly understood meanings” of
these terms. Reply Br. 3 (emphasis omitted). Appellant also contends that
“[t]he paragraph bridging pages 8 and 9 of the specification provides
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sufficient description for one of ordinary skill to understand what is meant
by being configured ‘to catch and guide an annuloplasty implant.’” Id.
We are not persuaded of Examiner error. As an initial matter,
Appellant does not appear to dispute that Liddicoat’s mounting ring
segments are adapted “to guide” an annuloplasty implant. See Appeal Br. 7
(“[t]he implant can be guided to a position in the body while mounted to
mounting ring 140”). Nor does there appear to be any dispute that grooves
260 are “c-shaped.” The dispute, then, is whether the grooved mounting
ring segments are adapted “to catch” an annuloplasty implant.
During prosecution, the PTO gives claims their broadest reasonable
interpretation consistent with the specification. In re Bigio, 381 F.3d 1320,
1324 (Fed. Cir. 2004). Although Appellant alludes to a “commonly
understood meaning” of “to catch” (Reply Br. 3), Appellant does not set
forth this meaning or support such a meaning with evidence. Nor does the
excerpt of the Specification that Appellant relies on (Spec. 9:1–4, 20–21)
provide any specific definition for “to catch.” Although this excerpt
discusses an embodiment that “catch[es] and guides an upper part of [a]
helix ring,” that embodiment does so using “anchors 7” attached to the
commissures of the annulus, each in the form of a “guiding unit or ring,”
rather than a ring-shaped or c-shaped opening at the measurement end of an
extension member, as recited in claim 1. Spec. 8:23–9:8, Fig. 5. Thus,
while the Specification discloses using implanted anchors to catch and guide
an annuloplasty implant, we are unable to find any discussion in the
Specification of a guide having “a c-shaped opening” that catches and guides
an annuloplasty implant, in whole or part, helix-ring shaped or otherwise.
From what we can glean from the Specification’s discussion of the anchors
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“catch[ing]” and guiding a part of an annuloplasty ring, “to catch” means to
hold in place. With this understanding, we are not persuaded that the
Examiner erred in finding that Liddicoat’s grooved mounting ring segments
catch the annuloplasty band because the band is mounted to the segments.
(ii) the guide having a ring-shaped or c-shaped opening sized to
allow passage of the annuloplasty implant to pass through it
Appellant next argues that Liddicoat does not teach “[a] guide having
a ring-shaped or c-shaped opening sized to allow passage of the annuloplasty
implant therethrough.” Appeal Br. 5–8. Appellant asserts that “[p]assing
through an opening inherently requires relative motion between the object
that is moving and the opening through which the object passes.” Id. at 5.
Appellant contends that “it would be impossible for an annuloplasty implant
to pass through groove 260 because passing through the [groove] would
require an annuloplasty implant to enter into, traverse, and exit the groove
260.” Id. at 7–8. Appellant further submits that Liddicoat’s mounting ring
“is specifically designed to prevent the implant from moving.” Id. at 8.
According to Appellant, “[p]assing an implant through an opening is in no
way equivalent to mounting an implant in a groove and later dismounting
the implant.” Id.
The Examiner responds that “the claims are drawn to the structure of
the device and not to specific method steps . . . i.e. no mention that the
implant needs to slide from one end to an opposite end or that require the
implant to enter into, traverse the groove and exit the groove.” Ans. 5. The
Examiner finds that “the opening of [Liddicoat’s] guide allows an implant to
pass into/out of the opening and is therefore sized to allow the implant to
pass through it.” Id.; see id. at 6 (Examiner’s annotated Figure 5 of
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Liddicoat). In its Reply Brief, Appellant counters that “[t]he Examiner
provides no explanation for how an implant could pass through the groove
260 as opposed to entering into the groove and coming back out the same
way it entered,” and “[i]t appears that the Examiner does not acknowledge
the objective fact that there is a difference in meaning between ‘to pass
through’ and mounting followed by dismounting.” Reply Br. 3 (emphasis
omitted).
The Examiner is correct that claim 1, as an apparatus claim, is “drawn
to the structure of the device and not to specific method steps.” Ans. 5.
Claim 1 is drawn to the “size[]” of the opening: the opening should be of
sufficient size to allow passage of the annuloplasty implant through the
opening. Contrary to the implicit premise of Appellant’s argument, claim 1
does not actually require that an annuloplasty implant be passed through the
guide opening.4 Thus, the fact that Liddicoat teaches mounting the implant
to the mounting ring segments rather than passing the implant through them
is insufficient to show error in the Examiner’s finding that Liddicoat teaches
an opening having the claimed size.
(iii) the annuloplasty implant is implantable through the ring-
shaped or c-shaped opening of the guide at the first commissure
when the guide is in apposition with the first commissure
According to Appellant, this limitation means that “the annuloplasty
implant can pass through the opening even when the guide is close to or
touching the commissure.” Appeal Br. 6. Appellant asserts that “[i]t is not
possible for an implant [to] pass through the groove 260 as the implant is

4 Further, the size requirement of claim 1 is quite broad, because claim 1
does not specify the size of the annuloplasty implant that should be able to
pass through the opening.
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inserted into or affixed to the heart valve because the implant is fixedly
mounted to the mounting ring 140 until after the implant has been
implanted.” Id. at 8 (citing Liddicoat ¶ 47, Fig. 12). Appellant contends that
“the very concept of ‘passing through’ does not apply to an annuloplasty
implant in relation to the groove 260.” Id. Appellant further submits that
“because Liddicoat’s annuloplasty band must exit the groove 260 in the
same direct [sic] from which it is mounted, Liddicoat literally discloses that
the groove 260 is sized and shaped to prevent the tissue band (implant) from
passing through the groove.” Id.
The Examiner responds that “the claims are drawn to the structure of
the device and do not include any specific steps about how the implant is
implanted through the opening nor does the claim include any limitations
specifying a specific order to steps of implanting an implant.” Ans. 7. That
is, according to the Examiner, “the claims do not include any limitations that
discuss the direction an implant can enter/pass through or be implanted nor
do they include any limitations that would preclude an implant from
entering/exiting the same direction.” Id.
We agree with the Examiner. Appellant’s argument is premised on
claim 1 requiring implantation of an annuloplasty implant. Instead, claim 1
is drawn to the structure of a medical device intended to catch and guide an
implant for implantation; it does not require implantation of an implant (or,
for that matter, the implant itself). Therefore, the specific way Liddicoat
teaches that its device is used is not particularly relevant to whether
Liddicoat’s device satisfies the structural and functional requirements of
claim 1. Further, even if we were to apply Appellant’s interpretation of this
limitation as meaning that “the annuloplasty implant can pass through the
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opening even when the guide is close to or touching the commissure,”
Appellant has not adequately explained why Liddicoat’s device does not
satisfy this limitation. Accordingly, we are not persuaded of Examiner error.
(iv) Liddicoat disclosing a catheter
The Examiner finds that cylinder 150 of handle 130 (or, alternatively,
handle 130B) corresponds to the claimed catheter. Final Act. 3 (citing
Liddicoat, Figs. 3–7, 8–11, 21, 22). Appellant responds that “a catheter
must be flexible to function as a catheter” (implying cylinder 150/handle
130B is not flexible). Appeal Br. 9. Appellant notes that the Examiner had,
in an earlier Advisory Action, previously interpreted “catheter” as “a tubular
medical device for insertion into canals, vessels, passageways, or body
cavities,” but Appellant submits “[t]he interpretation that a catheter need not
be flexible is in contradiction to the medical usage of the term, which
requires flexibility.” Id. In the Answer the Examiner responds that because
“Liddicoat includes a tubular member that is inserted into a body
cavity/passageway to deliver the guide towards the valve, the handle of
Liddicoat can be interpreted as a catheter.” Ans. 8.
Appellant does not appear to dispute the Examiner’s finding that
“Liddicoat includes a tubular member that is inserted into a body
cavity/passageway to deliver the guide towards the valve.” Instead,
Appellant’s argument is that this tubular member is not a catheter because it
is not flexible. However, Appellant has not provided any evidence that one
of ordinary skill in the art would have understood that all catheters are
flexible, or what degree of flexibility would necessarily be required for a
catheter. Appellant’s assertion that “[a]ll definitions for ‘catheter’ of which
Appellant is aware include variations of ‘flexible’ or ‘soft’” is therefore
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unsupported attorney argument, to which we accord little weight. Appeal
Br. 10; see Icon Health & Fitness, Inc. v. Strava, Inc., 849 F.3d 1034, 1043
(Fed. Cir. 2017) (explaining that unsworn attorney argument is not
evidence).
In sum, as we are not persuaded that the Examiner erred in rejecting
claim 1, we sustain the Examiner’s rejection of claims 1, 3–6, 8, 10, and 11
as anticipated by Liddicoat.
Claim 13
Claim 13 reads: “The medical device according to claim 1, further
comprising a leaflet limiter arranged at the extension member.” Appeal Br.
15 (Claims App.). The Examiner finds that the lateral stays 240 on
mounting ring 140 correspond to the claimed leaflet limiter. Final Act. 6;
see Liddicoat, Fig. 5.
Appellant responds that “[t]he rejection does not explain how the
stays 240 disclosed by Liddicoat anticipate the leaflet limiter recited in claim
13 and therefore fails to establish prima facie anticipation.” Appeal Br. 10
(emphasis omitted).
The procedural burden of establishing a prima facie case of
unpatentability is met by a rejection that complies with 35 U.S.C. § 132; that
is, the rejection must state reasons for the rejection together with information
and references as may be useful to the applicant in judging the propriety of
continuing prosecution. See In re Jung, 637 F.3d 1356, 1362 (Fed. Cir.
2011) (“all that is required of the office to meet its prima facie burden of
production is to set forth the statutory basis of the rejection and the reference
or references relied upon in a sufficiently articulate and informative manner
as to meet the notice requirement of § 132”); Chester v. Miller, 906 F.2d
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1574, 1578 (Fed. Cir. 1990) (“Section 132 merely ensures that an applicant
‘at least be informed of the broad statutory basis for [the rejection of] his
claims, so that he may determine what the issues are on which he can or
should produce evidence.’”). The Examiner has identified the statutory
basis for the rejection–§ 102(b)–and the specific reference and portion
thereof that corresponds to the structure recited in claim 13—e.g., lateral
stays 240 on mounting ring 140 of Liddicoat corresponding to claim 13’s
leaflet limiter. Therefore, the Examiner has established a prima facie case of
anticipation with respect to claim 13. See Jung, 637 F.3d at 1363 (holding
that “the examiner’s discussion of the theory of invalidity (anticipation), the
prior art basis for the rejection (Kalnitsky), and the identification of where
each limitation of the rejected claims is shown in the prior art reference by
specific column and line number was more than sufficient to meet this
burden”).
Because the Examiner established a prima facie case of anticipation,
the burden shifted to Appellant to rebut it. Jung, 637 F.3d at 1365.
Appellant has failed to do so. At best, Appellant’s response can be
considered an assertion that Liddicoat does not disclose a leaf limiter. But
Appellant does not, for example, explain why lateral stays 240 cannot be
considered as corresponding to the claimed leaflet limiter, as the Examiner
finds. See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (“[W]e hold
that the Board reasonably interpreted Rule 41.37 to require more substantive
arguments in an appeal brief than a mere recitation of the claim elements and
a naked assertion that the corresponding elements were not found in the
prior art.”). Therefore, we are not persuaded that the Examiner erred in
rejecting claim 13 as anticipated by Liddicoat.
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Claims 1, 4–8, 10, 11, and 13–16—§ 103—Ryan and Liddicoat
Appellant argues claims 1, 4–8, 10, 11, and 13–16 as a group. Appeal
Br. 10–11. We select claim 1 as representative of the group, and decide the
appeal of this rejection on the basis of claim 1 alone. 37 C.F.R.
§ 41.37(c)(1)(iv).
The Examiner finds that Ryan teaches the medical device of claim 1
except that Ryan “fails to disclose means for guiding the annuloplasty
implant.” Final Act. 8. The Examiner relies on Liddicoat, particularly ring
mount segments 210 with grooves 260, “where the implant can occupy the
groove and therefore the groove is being interpreted as a c-shaped opening
that is sized to allow passage of the implant therethrough.” Id. at 9.
In response, Appellant contends that:
Given that no portion of the Liddicoat system is sized or
configured for catheter delivery and that Ryan discloses a
device that is delivered via a minimally invasive route, one of
ordinary skill in the medical arts would not reasonably have
modified Ryan’s device according to the teachings of Liddicoat.
Doing so would have rendered Ryan’s device inoperable for its
intended minimally invasive purpose, making any expectation
of success unreasonable.
Appeal Br. 11.
The Examiner responds that the rejection does not propose modifying
Liddicoat’s device, but rather “the combination was used to modify the sizer
of Ryan to include a guide/groove around the edge of the sizer device of
Ryan; where the guide/groove is adapted to catch/guide an annuloplasty
implant as suggested by Liddicoat such that a single system could be used to
measure the site and deliver the correct sized/shaped implant.” Ans. 9.
According to the Examiner, “[s]ince the combination does not incorporate
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the actual device of Liddicoat and modifying the sizer of Ryan to include the
guide/groove would still allow the device to operate as intended for a
minimally invasive procedure the arguments are not persuasive.” Id.
We are not persuaded of Examiner error. Appellant’s argument
appears to be based on the bodily incorporation of Liddicoat’s device with
Ryan’s device, where the resulting device is contended to be unsuitable for
minimally invasive surgery. But the rejection is based on a much more
limited combination of the teachings of the two references. See In re Keller,
642 F.2d 413, 425 (CCPA 1981) (“The test for obviousness is not whether
the features of a secondary reference may be bodily incorporated into the
structure of the primary reference . . . [r]ather, the test is what the combined
teachings of the references would have suggested to those of ordinary skill
in the art.”). That is, the Examiner is proposing only modifying Ryan’s
device by adding a guide/groove around the edge of the device. Ans. 9.
Appellant does not explain why this modification would have rendered
Ryan’s device unfit for minimally invasive surgery.
Because we are not persuaded that the Examiner erred in rejecting
claim 1, we sustain the Examiner’s rejection of claims 1, 4–8, 10, 11, and
13–16 as unpatentable over Ryan and Liddicoat.
Claim 3—§ 103—Ryan, Liddicoat, and Liddicoat ’486
Appellant advances no separate arguments in support of the
patentability of claim 3, but instead relies on claim 3’s dependency from
claim 1 for patentability. Appeal Br. 12. As we are not persuaded that the
Examiner erred in rejecting claim 1 as unpatentable over Ryan and
Liddicoat, we also sustain the Examiner’s rejection of claim 3 as
unpatentable over Ryan, Liddicoat, and Liddicoat ’486.
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CONCLUSION
The Examiner’s rejections are affirmed.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3–6, 8,
10, 11, 13
102 Liddicoat 1, 3–6, 8,
10, 11, 13

1, 4–8, 10,
11, 13–16
103 Ryan, Liddicoat 1, 4–8, 10,
11, 13–16

3 103 Ryan, Liddicoat,
Liddicoat ’486
3
Overall
Outcome
1, 3–8, 10,
11, 13–16

TIME PERIOD FOR RESPONSE
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).
AFFIRMED