Samuel Lichtenstein et al.

Patent Trials and Appeals Board

Jan 29, 2021

2020001437 (P.T.A.B. Jan. 29, 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.
12/904,885 10/14/2010 Samuel Victor Lichtenstein KARD-0015US1A 6822
37013 7590 01/29/2021
Rossi, Kimms & McDowell LLP
20609 Gordon Park Square
Suite 150
Ashburn, VA 20147
EXAMINER
COLELLO, ERIN L
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
01/29/2021 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):
EOfficeAction@rkmllp.com
mail@rkmllp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SAMUEL VICTOR LICHTENSTEIN, DANIEL GELBART, and
WILLIAM GELBART
Appeal 2020-001437
Application 12/904,885
Technology Center 3700

Before DANIEL S. SONG, CHARLES N. GREENHUT, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.

SONG, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s decision to reject claims 13–24, 38–47, 50, 51, 53, 57, and 61–
83. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
CLAIMED SUBJECT MATTER
The claims are directed to a cardiac medical device. Claim 13,
reproduced below, is illustrative of the claimed subject matter:

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). The Appellant identifies the real party in interest as
KARDIUM INC. Appeal Br. 1.
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13. A cardiac medical device, comprising:
a plurality of elastic arms physically coupled together, the
plurality of elastic arms movable between a first configuration in
which the cardiac medical device is sized to be inserted into a left
ventricle of a heart and a second configuration in which the
plurality of elastic arms are configured to physically engage
portions of a wall that forms the left ventricle and exert
expansion force to assist an expansion of the left ventricle during
a diastolic phase of a cardiac cycle,
wherein a portion of at least one elastic arm of the
plurality of elastic arms includes a respective 360 degree loop
configured to increase elasticity of the at least one elastic arm
and located at least proximate a location where the plurality of
elastic arms are physically coupled together, the respective 360
degree loop protruding into an interior volume bounded by the
plurality of elastic arms.
Appeal Br. 37 (Claims App.).
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Beyer US 6,881,218 B2 Apr. 19, 2005
Shachar US 7,280,863 B2 Oct. 9, 2007
Feld US 2004/0002626 A1 Jan. 1, 2004
Suresh US 2006/0025800 A1 Feb. 2, 2006
REJECTIONS2
1. Claims 13–24, 38–47, 50, 51, 53, 57, and 61–83 are rejected
under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, as
failing to comply with the written description requirement. Final Act. 4.3

2 The rejections based on US 2003/0050682 A1 to Sharkey have been
withdrawn by the Examiner. Ans. 4.
3 The rejection of claim 69 has been withdrawn by the Examiner. Ans. 4.
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2. Claims 45, 46, 75, and 76 are rejected under 35 U.S.C. § 112(b)
or 35 U.S.C. § 112 (pre-AIA), second paragraph, as being indefinite. Final
Act. 8; Ans. 3–4.4
The Examiner also rejects the claims on appeal under pre-AIA 35
U.S.C. § 103(a) as follows:
3. Claims 13, 20, 22, 23, 51, 53, and 57 as unpatentable over Feld
in view of Beyer. Final Act. 13.
4. Claim 50 as unpatentable over Feld in view of Beyer and
Shachar. Final Act. 16.
5. Claims 16 and 24 as unpatentable over Feld in view of Beyer
and Suresh. Final Act. 17.
OPINION
Rejection 1: Written Description
The Examiner rejects claims 13–24, 38–47, 50, 51, 53, 57, and 61–83
as failing to comply with the written description requirement. Final Act. 4.
According to the Examiner, the limitation of claim 13 reciting the loop
“protruding into an interior volume bounded by the plurality of elastic
arms,” as well as a similar limitation in claim 61 reciting “the coiled loop
structure protrudes into a space” bounded by the arms lack support in the
Specification. Final Act. 4. The Examiner explains that the Specification
“does not provide details regarding the loops/coils” and there is nothing in
the disclosure describing the recited limitations. Final Act. 4–5. The
Examiner points out that “the figures are only two dimension[al],” are hand
drawn, and not stated to be drawn to scale so as to support the limitations at

4 This rejection has been withdrawn by the Examiner as to claims 14, 15,
17–19, 21, 38–44, and 47. Ans. 3–4.
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issue. Final Act. 5; Ans. 5. According to the Examiner, “the loops/coils
could extend left or right and even with the wires and not into the interior
volume bounded by the arms.” Final Act. 5.
The Appellant argues that “at least FIG. 3 of the present application
reasonably show[s] the loops protruding into the interior volume,” and
referring to an annotated and enlarged partial view of Figure 3, argues that
annotated “Arm 1” has “Loop 1” that protrudes inwardly into an interior
volume as recited in claim 13. Appeal Br. 3–4 (quoting Amendment filed
Nov. 28, 2017, pg. 16). According to the Appellant, in view of Figure 3 and
the statement in the Specification that “[f]or added elasticity small loops 12
can be added” subsequent to discussing elastic arms (Spec. 3.), a person of
ordinary skill would have understood that the loops protrude into the interior
volume. Appeal Br. 3. In further support, the Appellant argues that:
From the perspective of a person of ordinary skill in the art, the
loops 12 add elasticity with respect to the force exertion on the
ventricle wall. Accordingly, if the loops 12 somehow protruded
‘sideways’ . . . they would, at best, not properly facilitate the
force exertion on the ventricle wall and, at worst, would inhibit
such force exertion.
Appeal Br. 3 (quoting Amendment filed Nov. 28, 2017, pg. 16); see also
Reply Br. 3.
We agree with the Appellant because the Examiner does not appear to
consider what the disclosure in the Specification conveys to those skilled in
the art. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.
Cir. 2010) (“test for sufficiency is whether the disclosure of the application
relied upon reasonably conveys to those skilled in the art that the inventor
had possession of the claimed subject matter as of the filing date.”).
Although Figure 3 is hand drawn and not to scale, it is nonetheless a
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perspective view that reasonably shows at least one loop within the interior
volume of the medical device. See In re Aslanian, 590 F.2d 911, 914
(CCPA 1979); In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972) (drawings can
be relied on for what they reasonably disclose and suggest to one of ordinary
skill in the art); Spec. Fig. 3. Such understanding of Figure 3 is bolstered by
the disclosure in the Specification as to the function of the loop in increasing
elasticity of the elastic arm, as well as the intended function of the medical
device itself, which is to provide elastic arms that embed into the walls of
the left ventricle to gently expand the left ventricle while also having little
effect on systolic performance of the heart. See Spec. 2–3. In that regard,
the loop is illustrated as being configured like a single coil torsion spring.
See Spec. Fig. 3. If the loops were oriented to extend along the surface of
the volume of the medical device as posited by the Examiner, it is not
entirely clear, and the Examiner does not adequately explain, how such a
loop would serve the recited function of increasing elasticity of the elastic
arms, or the function of the medical device.
Accordingly, we agree with the Appellant that Figure 3 and the
Specification reasonably convey to those skilled in the art that the Appellant
had possession of the claimed subject matter. Therefore, we reverse this
rejection as to claims 13 and 61, as well as dependent claims 14–24, 39–47,
50, 51, 53, 57, 62–67, and 69–83.
Claims 38 and 68
The Examiner further rejects dependent claims 38 and 68, finding
these claims additionally lack sufficient support in the Specification for the
recitation that the at least one flexible cross-member expansion limiter is
coupled “at a respective location on each of the arms that does not vary as
the arms move between first and second configurations.” Final Act. 6;
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Appeal Br. 39, 46 (Claims App.). The Examiner explains that the
Specification “does not mention that the limiter is permanently coupled or
coupled to have a fixed position or that the positions do not move/vary or
any other similar phrase.” Final Act. 6–7.
The Appellant disagrees and argues that Figure 3 depicts “at least one
cross-member expansion limiter is physically coupled to a pair of non-
adjacent arms at respective loops on each arm. Since each of these loops is
formed from the respective arm itself, the respective location of such loop on
its respective arm does not vary,” so as to provide sufficient descriptive
support. Appeal Br. 8–9. The Appellant points out that similar loops on the
arm for attachment of another cross-member expansion limiter is shown in
Figure 5-A. Reply Br. 6; see also Ans. 6. The Appellant further points out
that the Specification discloses “[t]he purpose of members 9 and 10 is to
limit the maximum dilation of the ventricle and stop ventricular
enlargement,” and that “it would harm this purpose to attach the cross
members 9 and 10 at locations that would vary along the respective arms.”
Appeal Br. 9 (quoting Spec. 3, ll. 27–29). Thus, the Appellant argues that:
a person skilled in the art would reasonably conclude that the
loops for cross member 10, the loops for cross member 9, and
the loops at the base near 12 are all integrally formed by their
respective arms, which is consistent with the plain view of
FIGS. 3 and 5-A of the present application.
Reply Br. 7.
We again agree with the Appellant for the reasons argued. Although
the Examiner explains that the Specification does not “provide any details
with respect to the location of the connection or any use of the language
‘does not vary’ or similar language (i.e. permanently fixed etc.)” (Ans. 6),
the Appellant is correct that there is no in haec verba requirement, and the
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figures are included as part of the disclosure which may be relied upon for
descriptive support. Appeal Br. 9; see also Ariad, 598 F.3d at 1352 (“the
description requirement does not demand any particular form of disclosure .
. . or that the specification recite the claimed invention in haec verba.”); see
also In re Wolfensperger, 302 F.2d 950 (CCPA 1962) (“The issue here is
whether there is supporting ‘disclosure’ and it does not seem, under
established procedure of long standing, approved by this court, to be of any
legal significance whether the disclosure is found in the specification or in
the drawings so long as it is there.”) (cited at MPEP § 2163(II)(3)(a)). In
that regard, Figure 3 shows loops at the distal ends of the elastic arms, and
connection of the cross-member 9 to these loops so as to at least show the
location at which the flexible cross-member 9 is coupled to the elastic arms.
In addition, although Figure 3 does not show the level of detail as to
the loops for cross-members 9 as compared to loops for cross-member 10 in
Figure 5-A, such disclosure in Figure 5-A would inform those of ordinary
skill as to how the loops at the distal ends of the elastic arms would be
formed, especially considering the related functions of cross-members 9 and
10 that are both coupled to the elastic arms. See Fig. 5-A. In addition, as the
Appellant argues, it is not apparent how the disclosed purpose of cross-
member 9, which is to “limit the maximum dilation of the ventricle and stop
ventricular enlargement,” would be attained if the location at which the
cross-member is coupled to the arm varied, for example, moved down the
elastic arm from the distal end. Appeal Br. 9 (quoting Spec. 3, ll. 27–29).
Therefore, in view of the above considerations, we also reverse this
rejection as to claims 38 and 68.

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Rejection 2: Indefiniteness
The Examiner rejects claims 45, 46, 75, and 76 as being indefinite,
claims 46 and 76 depending from claims 45 and 75, respectively. Final Act.
8; Ans. 3–4. Claim 45 depends from claim 38 and recites that the coupling
position between “the at least one flexible cross-member expansion limiter”
and sets of elastic arms be above and below the papillary muscles. Appeal
Br. 42 (Claims App.). In discussing claim 45 as an example, the Examiner
notes that this claim ultimately depends from claim 38, which recites “at
least one flexible cross-member expansion limiter.” Final Act. 9. The
Examiner determines that claims 45 and 46 are
vague and indefinite since it is unclear if the same expansion
limiter is coupled to the first set and the second set and a pair of
non-adjacent arms and if so how the single limiter couples to
the first set, the second set both above and below the papillary
muscles.
Final Act. 9. The Examiner further explains that:
if the at least one flexible cross-member expansion limiter
includes two flexible cross-member expansion limiters . . . the
claims should clarify that the at least one flexible expansion
limiter includes first and second flexible expansion limiters
where one is coupled to the first set of arms and one is coupled
to the second set of arms.
Final Act. 9. According to the Examiner, “[s]ince the scenario does not
appear to be supported [by the Specification], the limitation is additionally
unclear.” Final Act. 10.
The Appellant argues that Figure 3 “provides an example of a flexible
cross-member expansion limiter, collectively comprising cross members 9,
10,” which are connected above and below the papillary muscles as claimed.
Appeal Br. 14. However, as correctly noted by the Examiner, claims 38 and
68 recite that the flexible cross-member expansion limiter is “coupled at
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Application 12/904,885
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least to a pair of non-adjacent arms” thereby limiting the recitation to cross-
member 9, whereas cross-member 10 couples a pair of adjacent arms. Ans.
7 (“Since claims 45 and 75 refer to the same cross member mentioned in
claims 38 and 68 and Ref 10 does not couple non-adjacent arms and couple
to a set of arms below the papillary muscles, it is still unclear how the at
least one cross-member can coupled non-adjacent arms and connect to some
arms above and some arms below.”). Accordingly, the Appellant’s
reference to cross-member 10 is unpersuasive.
Nonetheless, the Appellant also correctly points out that “the recited
‘at least one flexible cross-member expansion limiter’ may include multiple
cross-members each performing a subset of the functions attributed to ‘the at
least one flexible cross-member expansion limiter’.” Reply Br. 8. In that
regard, the Specification teaches that “[t]he number of flexible members of
device 4 and number of cross members can vary, the preferred embodiment
having from 3 to 12 elastic members. Cross members can connect adjacent
elastic members as members 10 do, or connect opposing members as
members 9 do.” Spec. 3–4. Thus, we agree with the Appellant that “those
skilled in the art would understand what is claimed when the claim[s] [are]
read in light of the [S]pecification.” Orthokinetics, Inc. v. Safety Travel
Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986).
Therefore, in view of the above considerations, we reverse this
rejection of claims 45, 46, 75, and 76.

Rejection 3: Feld in view of Beyer
The Examiner rejects claims 13, 20, 22, 23, 51, 53, and 57 as being
unpatentable over Feld in view of Beyer. Final Act. 13. As to independent
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claim 13, the Examiner finds that Feld discloses a cardiac medical device
substantially as claimed,
but fails to explicitly disclose that a portion of at least one
elastic arm of the plurality of elastic arms includes a respective
360 degree loop configured to increase elasticity of the at least
one elastic arm and located at least proximate a location where
the plurality of elastic arms are physically coupled together.
Final Act. 13 (citing Feld Figs. 4a, 4b, 5a, 5b, ref. 12', 12").
The Examiner relies on Beyer to remedy the deficiency of Feld,
finding that eyes 24 on filter struts 16 shown in Figures 1 and 3a of Beyer
discloses the 360 degree loop as claimed. Final Act. 13–14 (citing Beyer
Figs. 1, 3a, ref. 16, 24). The Examiner concludes that it would have been
obvious to one of ordinary skill to have:
modif[ied] the plurality of elastic arms of Feld to include a
respective 360 loop proximal a location where the arms are
physically coupled together as suggested by Beyer, since such a
modification provides a well-known structure/technique to
connect two parts together (i.e. at least one arm and a ring), where
such a connection would allow the at least one arm to have slight
movement with respect to the ring.
Final Act. 14–15.
The Appellant disagrees and argues that providing the elastic arms of
Feld with an eye as disclosed in Beyer would not increase elasticity of an
elastic arm as recited by claim 13. Appeal Br. 21. In that regard, the
Appellant notes that in Beyer, “the ring structure around eye 24 [is] an
attachment point to apply a force,” and that Beyer does not disclose the eye
as increasing elasticity of Beyer’s strut 16. Appeal Br. 22. According to the
Appellant, “utilizing the ring structure around eye 24 as an attachment point
to apply a force says nothing about the ability of the strut 16 to return to its
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normal shape when force ceases to be applied to it, let alone increasing
elasticity of the strut 16.” Appeal Br. 22.
We generally agree with the Appellant. Initially, it is not readily
apparent why one of ordinary skill in the art would have provided eyes
positioned toward the lower end region 16 of the elastic arms 12 of Feld as
suggested considering Beyer teaches providing such eyes at the distal ends
of the filter struts 12. Although the Examiner asserts that such positioning is
suggested because the eyes are near where the filter struts of Beyer are
coupled together (Final Act. 14–15), Beyer actually discloses that the eyes
24 are positioned at the distal ends of its filter struts 12 so that a frangible
connector/flexible cord 18 can extend through the eyes 24 of the filter struts
12 to bring the otherwise separated ends of the struts together and form the
blood clot filter. Beyer col. 2, ll. 17–21, 54–59; col. 3, ll. 10–15; Figs. 1–
3A. In contrast, the ventricular device of Feld already includes elastic arms
that are integrally coupled together such that the elastic arms do not need to
be further coupled together. Accordingly, the Examiner’s articulated basis
for providing such eyes positioned toward the lower end region 16 of the
filter struts 12 of Feld does not appear to be based on rational underpinnings.
In addition, even if such eyes are positioned toward the lower end
region 16 of the elastic arms 12 of Feld as suggested, the Examiner does not
explain how such eyes would then increase the elasticity of the arms of Feld.
According to the Examiner:
connecting of two parts together (i.e. at least one arm and a ring)
utilizing a 360 degree loop allows the at least one arm to have
slight movement with respect to the ring and therefore allows the
at least one arm to adjust its shape/change position and
resume/adapt its normal shaped/position . . . [which] is being
interpreted to increase the elasticity of the arm (i.e. the ability of
the arm to change/adapt/resume its normal shape/posit[i]on).
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Final Act. 14; see also Ans. 8.
However, the Examiner does not provide any basis for the assertion
that there will be “slight movement” between the arm and the ring/eye
provided thereon. Furthermore, we agree with the Appellant that “the
Examiner’s interpretation and definition of elastic is improper.” Appeal Br.
22. It is unreasonably broad to interpret “increase elasticity of the at least
one elastic arm” recited in claim 13 to encompass mere adjusting or
changing the position of an elastic arm. In the context of the Specification,
we agree with the Appellant that “elasticity is the ability of an object to
return to its normal shape when force ceases to be applied to it.” Appeal Br.
21.
The Examiner also responds that because the Specification merely
states that a loop can be added for added elasticity without details as to how
the loop increases elasticity, adding the loop of Beyer would also increase
elasticity. Ans. 8. However, the claim recites “360 degree loop configured
to increase elasticity of the at least one elastic arm,” and Figure 3 depicts a
360 degree loop that is configured like a single coil torsion spring. Spec.
Fig. 3. Accordingly, the Examiner’s assertion that the loop of Beyer would
increase the elasticity of Feld’s elastic arm, without supporting disclosure in
Beyer, or other explanation by the Examiner, is insufficient to support the
rejection.
Thus, in view of the above, we reverse the rejection of claim 13, and
claims 20, 22, 23, 51, 53, and 57 ultimately depending from claim 13. The
Appellant’s further arguments directed to whether the loop defining the eye
can properly be considered to define part of the interior volume (Appeal Br.
22–24) and whether the outer tips of the filter struts of Beyer can be properly
considered to define the interior volume (Appeal Br. 24–26) are moot.
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Rejections 4 and 5: Feld in view of Beyer and Shachar or Suresh
The Examiner rejects claim 50 as being unpatentable over Feld in
view of Beyer and Shachar, and rejects claims 16 and 24 as being
unpatentable over Feld in view of Beyer and Suresh. Final Act. 16–17. The
Examiner’s application of Shachar or Suresh does not cure the deficiency of
the combination of Feld and Beyer. See also Appeal Br. 33–34. Therefore,
we reverse these rejections as well.

CONCLUSION
The Examiner’s rejections are reversed.

DECISION SUMMARY

In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/B
asis
Affirmed Reversed
13–24, 38–47,
50, 51, 53, 57,
61–83
112, first
paragraph
Written
Description
13–24, 38–47,
50, 51, 53, 57,
61–83
45, 46, 75, 76 112,
second
paragraph
Indefiniteness 45, 46, 75, 76
13, 20, 22, 23,
51, 53, 57
103(a) Feld, Beyer 13, 20, 22, 23,
51, 53, 57
50 103(a) Feld, Beyer,
Shachar
50
16, 24 103(a) Feld, Beyer,
Suresh
16, 24
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Overall
Outcome
13–24, 38–47,
50, 51, 53, 57,
61–83

REVERSED