CVDEVICES, LLC

Patent Trials and Appeals Board

Aug 14, 2020

2019007013 (P.T.A.B. Aug. 14, 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.
14/377,619 08/08/2014 Ghassan S. Kassab 1000-651 9972
42715 7590 08/14/2020
MacMillan, Sobanksi & Todd, LLC - Cook Medical
One Maritime Plaza, Fifth Floor
720 Water Street
Toledo, OH 43604
EXAMINER
PELLEGRINO, BRIAN E
ART UNIT PAPER NUMBER
3799
NOTIFICATION DATE DELIVERY MODE
08/14/2020 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):
MST@mstfirm.com
pair@ipbybv.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GHASSAN S. KASSAB, JOSE A. NAVIA,
JORGE JORDANA, and ZACHARY C. BERWICK
Appeal 2019-007013
Application 14/377,619
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 133, 134, 141, 142, and 197–212. See
Final Act. 1. An oral hearing in accordance with 37 C.F.R. § 41.47 was held
on August 6, 2020, a transcript of which will be entered into the record in
due course. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM IN PART.

1 “Appellant” refers to the applicant as defined by 37 C.F.R. § 1.42.
Appellant identifies the real parties in interest as CVDevices, LLC; its
exclusive licensee, 3DT Holdings, LLC; and 3DT Holdings’ exclusive
licensee, Cook Medical Technologies, LLC. Appeal Br. 3.
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CLAIMED SUBJECT MATTER
The claims are directed to products made from biological tissue that
are used for various stent and other medical applications. Claims 133, 134,
141, and 142 are independent, and are distinguishable from one another in
relevant part by the type of biological tissue used: Claims 133 and 141
recite using “pulmonary ligament,” claim 134 recites using “pulmonary
viscera,” and claim 142 recites using “visceral pleura.” Claim 133,
reproduced below, is illustrative of the claimed subject matter:
133. A product, comprising:
a frame configured to retain a mammalian tissue thereon; and
the mammalian tissue coupled to the frame;
wherein when the product is positioned within a mammalian
luminal organ, fluid native to the mammalian luminal organ may
pass through a lumen defined within the product;
wherein the mammalian tissue comprises mammalian
pulmonary ligament;
and wherein the mammalian tissue is fixed.
REFERENCES
Name Reference Date
Ketharanathan US 4,681,588 July 21, 1987
Ross US 5,352,240 Oct. 4, 1994
Grikscheit US 2003/0129751 A1 July 10, 2003
Holmberg US 2003/0139805 A1 July 24, 2003
Tian WO 2008/073582 A2 June 19, 2008
REJECTIONS
Claims Rejected 35 U.S.C. § Reference(s)/Basis
134, 204, 205 102 Ross
134, 204, 205 103 Ross, Tian
206 103 Ross, Tian, Holmberg
142, 210, 212 103 Ross, Ketharanathan
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Claims Rejected 35 U.S.C. § Reference(s)/Basis
211 103 Ross, Ketharanathan,
Holmberg
133, 141, 197–201, 203,
207, 208
103 Ross, Ketharanathan,
Grikscheit
202, 209 103 Ross, Ketharanathan,
Grikscheit, Holmberg
OPINION
A. Claims 134, 204, and 205—Rejected as Anticipated by Ross
Claim 134 recites a product comprising mammalian tissue coupled to
a frame, wherein the mammalian tissue comprises “pulmonary viscera.”
Appeal Br. 25 (Claims App.). Claims 204 and 205 depend from claim 134.
Id. at 28. The Examiner finds that Ross discloses “a product that includes a
frame 20 configured to retain a mammalian tissue thereon,” and that “the
mammalian tissue can be pulmonary viscera.” Final Act. 4 (citing Ross,
2:61–66, 3:63–66, Fig. 3. In doing so, the Examiner interprets “viscera” as
“any vital tissue.” Id. Thus, according to the Examiner, “since the
mammalian tissue harvested for coupling with a frame is pulmonary type
and is a vital organ, it is visceral tissue [that] meets the scope of the
limitation.” Id.
Appellant responds, inter alia, that Ross does not disclose using
“pulmonary type” tissue to make a medical product. Instead, Appellant
asserts that “Ross discloses use of a ‘porcine pulmonary valve,’” which is
“cardiac tissue, not pulmonary tissue.” Appeal Br. 7 (citing Ross, 3:35–36).
In the Answer, the Examiner disputes that “pulmonary valve tissue” is
cardiac tissue, because “the valve tissue used is clearly stated in the
reference and admitted by Appellant is labeled or considered pulmonary
valve tissue.” Ans. 8. The Examiner asserts that “[v]iscera according to
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dictionary.com is defined as: the organs in the cavities of the body,
especially those in the abdominal cavity,” and therefore “one of ordinary
skill in the art can consider a tissue such [as] a pulmonary valve to be termed
as pulmonary viscera since it clearly is a pulmonary tissue and taken from an
internal vessel or cavity of the body.” Ans. 8–9.
We disagree with the Examiner that Ross discloses using “pulmonary
viscera” for its medical product, and therefore do not sustain the Examiner’s
rejection of claims 134, 204, and 205 as anticipated by Ross. Ross teaches
using “a porcine pulmonary valve” to make a bioprosthesis. Ross, 2:45–64.
The pulmonary valve is “a semilunar valve between the pulmonary artery
and the right ventricle of the heart that prevents the blood from flowing back
into the right ventricle.” See Dictionary.com, https://www.dictionary.com/
browse/pulmonary-valve?s=ts (last visited Aug. 11, 2020). Therefore, we
agree with Appellant that the pulmonary valve is cardiac tissue rather than
pulmonary tissue.
B. Claims 134, 204, and 205—Rejected as Unpatentable over Ross
and Tian
Appellant does not separately argue the claims subject to this
rejection. Appeal Br. 10–11. Therefore, we select claim 134 as
representative of the claims, and decide the appeal of this rejection on the
basis of claim 134 alone. 37 C.F.R. § 41.37(c)(1)(iv).
For this rejection, the Examiner relies on Ross to teach the product
recited in claim 134 except for the use of pulmonary viscera, and relies on
Tian to teach using pulmonary viscera. Final Act. 4. (citing Tian ¶ 15).
Tian concerns “the preparation or storage of biological tissues used for
surgical implantation.” Tian ¶ 1. Tian teaches that:
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The biological tissue used in various embodiments of the
invention can be mammalian tissue, including human tissue,
such as tissue obtained from human donors or cadavers.
Bovine, ovine, equine, and porcine tissue can also be used. The
types of tissue used in these embodiments is the same tissue
used in common surgical procedures, and includes pericardium,
aortic and pulmonary roots and valves, tendons, ligaments,
skin, peritoneum, [fascia], pleura, mitral and tricuspid valves.
Id. ¶ 15. The Examiner finds, inter alia, that “‘pleura’ could be considered
pulmonary viscera.” Ans. 10.
Appellant responds that Tian “is completely silent as to use of
mammalian pulmonary viscera.” Appeal Br. 11. Appellant further asserts
that the Examiner “continues to vitiate the terms ‘mammalian’ and
‘pulmonary’ of the ‘mammalian pulmonary viscera’ limitation . . . such that
the term viscera can be used to replace the ‘mammalian pulmonary viscera’
limitation and read on any vital internal tissue.” Reply Br. 5.
We are not persuaded that the Examiner erred in rejecting claim 134
as unpatentable over Ross and Tian. Tian discloses using mammalian
“pleura,” and Appellant does not show error in the Examiner’s finding that
“pleura” could be considered pulmonary viscera. Nor is it self-evident why
that should be the case. The Specification does not define “pulmonary
viscera,” and there is nothing in the record demonstrating that the term itself
has a plain meaning to one of ordinary skill in the art. We look, therefore, to
its component words to discern its meaning. The term “pulmonary” means
“relating to, functioning like, associated with, or carried on by the lungs.”
Merriam-Webster.com Medical Dictionary, https://www.meriam-
webster.com/pulmonary#medicalDictionary (last visited Aug. 6, 2020). The
Examiner defines “viscera” as “the organs in the cavities of the body,
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especially those in the abdominal cavity.” Ans. 8. Appellant does not
dispute this construction. Thus, it is reasonable to construe “pulmonary
viscera” as referring to the lungs and organs in the abdominal cavity relating
to or affecting the lungs. Tian teaches that “mammalian tissue,” such as
“pleura,” can be used for the various embodiments of its invention. Tian
¶ 15. Ketharanathan, cited for other rejections discussed herein, provides
helpful background information in teaching that “[p]leura is a thin
membranous lining of the thoracic cavity and lungs.” Ketharanathan, 1:41–
42. The membranous lining of the lungs is an organ relating to the lungs,
and therefore can reasonably be considered “pulmonary viscera.” Therefore,
we sustain the Examiner’s rejection of claims 134, 204, and 205 as
unpatentable over Ross and Tian.
C. Claim 206—Rejected as Unpatentable over Ross, Tian, and
Holmberg
Appellant relies on dependency from claim 134 to support the
patentability of claim 206. Appeal Br. 11–12. Thus, because we sustained
the Examiner’s rejection of claim 134 as unpatentable over Ross, and Tian,
we likewise sustain the Examiner’s rejection of claim 206 as unpatentable
over Ross, Tian, and Holmberg.
D. Claims 142, 210, and 212—Rejected as Unpatentable over Ross
and Ketharanathan
Claim 142 recites a product comprising mammalian tissue coupled to
a frame, wherein the mammalian tissue comprises “visceral pleura.” Appeal
Br. 26–27 (Claims App.). Claims 210 and 212 depend from claim 142. Id.
at 29. The Examiner finds, inter alia, that Ross teaches the claimed product
except for the use of visceral pleura. The Examiner further finds that
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Ketharanathan teaches “that graft materials can be made from visceral
pleura.” Final Act. 5 (citing Ketharanathan, 1:19, 42–45). The Examiner
determines that it would have been obvious to one of ordinary skill in the art
to select (visceral pleura) as disclosed by Ketharanathan in the
stent valve of Ross because of its durability, see Ketharanathan,
since it has been held to be within the general skill of a worker
in the art to select a known material on the basis of its
suitability for the intended use as a matter of obvious design
choice.
Id. at 5–6 (citing In re Leshin, 277 F.2d 197 (CCPA 1960)).
Appellant responds that “Ketharanathan teaches use of parietal
pleura” rather than visceral pleura. Appeal Br. 13.
We agree. Ketharanathan teaches that:
Pleura is a thin membranous lining of the thoracic cavity and
lungs. The pleura covering the thoracic cavity is termed
parietal pleura and that covering the lungs is termed visceral.
The invention makes use of the parietal pleura.
Ketharanathan, 1:41–45. Thus, Ketharanathan discusses visceral pleura only
in the context of distinguishing it from the tissue that is used for
Ketharanathan’s invention. Because the Examiner’s determination of
unpatentability is premised on a finding that is not supported by the current
record, we do not sustain this rejection.
E. Claim 211—Rejected as Unpatentable over Ross,
Ketharanathan, and Holmberg
Claim 211 depends from claim 142. Appeal Br. 29 (Claims App.).
The Examiner’s rejection of claim 211 relies on the erroneous finding that
Ketharanathan teaches using visceral pleura in its invention. Final Act. 6.
Holmberg is not relied on to cure this deficiency. Therefore, we do not
sustain this rejection.
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F. Claims 133, 141, 197–201, 203, 207, and 208—Rejected as
Unpatentable over Ross, Ketharanathan, and Grikscheit
Independent claims 133 and 141 recite a product comprising
mammalian tissue coupled to a frame, wherein the mammalian tissue
comprises “pulmonary ligament.” Appeal Br. 25, 27 (Claims App.). Claims
197–201 and 203 depend from claim 133, and claims 207 and 208 depend
from claim 141. Id. at 27–28. The Examiner finds that Ross discloses a
stent valve that corresponds to the claimed product except it is not made
from mammalian tissue comprising pulmonary ligament. Final Act. 7. The
Examiner further finds that Ketharanathan teaches “that graft materials can
be made from lung tissue.” Id. (citing Ketharanathan, 1:19, 42–45). The
Examiner determines that it would have been obvious to one of ordinary
skill in the art
to use lung tissue as taught by Ketharanathan in the stent valve
of Ross because of its durability, see Ketharanathan, since it has
been held to be within the general skill of a worker in the art to
select[] a known material on the basis of its suitability for the
intended use as a matter of obvious design choice.
Id. (citing In re Leshin, 277 F.2d 197 (CCPA 1960)).
The Examiner also finds that Grikscheit teaches “that lung tissue can
suitably be used alternatively as a graft material,” and that “specific tissue
sources can be harvested from an organ.” Id. (citing Grikscheit ¶¶ 83, 84,
120, abstract). The Examiner determines that:
[O]ne of ordinary skill in the art being a highly educated
surgeon or technician and knowledgeable at the requirements
needed for the patient can selectively use a pulmonary ligament
as graft material per the teaching of Grikscheit . . . and in view
of Ketharanathan in the stent valve of Ross in designing a
product for a patient in need of replacement tissue valve
providing the desired properties for tissue integration.
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Id. (citing Grikscheit ¶¶ 94, 95).
Appellant responds that neither Ketharanathan nor Grikscheit teaches
using pulmonary ligament to make a medical product. Appeal Br. 18–19.
Instead, according to Appellant, Ketharanathan teaches using parietal pleura,
and Grikscheit teaches using lung tissue. Id. (citing Ketharanathan, 1:43–46,
Grikscheit ¶ 120).
In the Answer the Examiner counters that “Grikscheit taught lung and
its components can be harvested for graft purposes,” and that “a pulmonary
ligament is a known material or element as being part of the lung.” Ans. 14.
We agree with Appellant that neither Ketharanathan nor Grikscheit
teaches specifically using pulmonary ligament to make a tissue graft.
Grikscheit teaches using lung tissue, among other possible tissue types, for
producing tissue-engineered organs or portions thereof. Grikscheit ¶¶ 15,
83. The rejection is premised on the finding that pulmonary ligament is part
of the lung. Ans. 14. This is incorrect. The pulmonary ligament is part of
the pleura that surrounds the lungs (i.e., the visceral pleura), not the lung
itself (which Grikscheit uses) or the parietal pleura (which Ketharanathan
uses). See Merriam-Webster.com Medical Dictionary, https://www.meriam-
webster.com/medical/pulmonary%20ligament (last visited July 30, 2020)
(defining “pulmonary ligament” as “a supporting fold of pleura that extends
from the lower part of the lung on its surface opposite the mediastinum to
the pericardium”). Therefore, we do not sustain this rejection.
G. Claims 202 and 209—Rejected as Unpatentable over Ross,
Ketharanathan, Grikscheit, and Holmberg.
Claims 202 and 209 depend from claims 133 and 141, respectively.
Appeal Br. 28 (Claims App.). The rejection of claims 202 and 209 relies on
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the Examiner’s unsupported finding that Ketharanathan or Grikscheit
teaches using pulmonary ligament for tissue grafting. Holmberg is not relied
on to cure this deficiency. Therefore, for the reasons discussed above, we do
not sustain this rejection.
DECISION SUMMARY
The Examiner’s rejections are affirmed in part, as follows:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
134, 204,
205
102 Ross 134, 204,
205
134, 204,
205
103 Ross, Tian 134, 204,
205

206 103 Ross, Tian,
Holmberg
206
142, 210,
212
103 Ross,
Ketharanathan
142, 210,
212
211 103 Ross,
Ketharanathan,
Holmberg
211
133, 141,
197–201,
203, 207,
208
103 Ross,
Ketharanathan,
Grikscheit
133, 141,
197–201,
203, 207,
208
202, 209 103 Ross,
Ketharanathan,
Grikscheit,
Holmberg
202, 209
Overall
Outcome
134, 204–
206
133, 141,
142, 197–
203, 207–
212

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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 IN PART