Ex Parte Rojo

Patent Trial and Appeal Board

Apr 4, 2017

11256362 (P.T.A.B. Apr. 4, 2017)

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.
11/256,362 10/21/2005 Nicholas A. Rojo 50718-227454 8996
26694 7590 04/06/2017
VENABLE LLP
P.O. BOX 34385
WASHINGTON, DC 20043-9998
EXAMINER
PREBILIC, PAUL B
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
04/06/2017 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):
PTOMail@Venable.com
cavanhouten@venable.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NICHOLAS A. ROJO
Appeal 2015-0058441
Application 11/256,3622
Technology Center 3700
Before NINA L. MEDLOCK, KENNETH G. SCHOPFER, and
TARA L. HUTCHINGS, Administrative Patent Judges.
SCHOPFER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of
claims 8—12, 15—22, and 29-31. We have jurisdiction under 35 U.S.C.
§ 6(b).
1 Our decision references the Appeal Brief (“Appeal Br.,” filed Dec. 29,
2014) and Reply Brief (“Reply Br.,” filed May 15, 2015), and the
Examiner’s Answer (“Ans.,” mailed Mar. 17, 2015) and Final Office Action
(“Final Act.,” mailed May 8, 2014).
2 According to Appellant, “[t]he real party in interest is the Nicholas A. Rojo
Credit Shelter Trust, with Patricia G. Rojo as the trustee, the owner of
U.S. Patent Application No. 11/256,362 through succession from the
deceased inventor, Dr. Nicholas Rojo who passed on July 18, 2013.”
Appeal Br. 4.
Appeal 2015-005844
Application 11/256,362
We AFFIRM-IN-PART.
BACKGROUND
According to Appellant,
The present invention relates to implantable systems that
include various devices. Examples of such devices include
stents, stent grafts, and vascular grafts. The devices contain cells
capable of delivering therapeutic agents to a host in need. Such
cells are optionally capable of producing and releasing a
therapeutic agent in response to changing physiological cues
within a host. Such stents and devices may optionally contain
port, catheter, and containment envelope systems.
Spec. 12.
CLAIMS
Claims 8—12, 15—22, and 29—31 are on appeal. Claim 8 is illustrative
of the appealed claims and recites:
8. A medical device comprising:
an elongated catheter comprising an intravascularly
implantable tip end and a port end; and
a porous sac radially disposed about and enclosing said tip
end thereby forming a containment envelope between said sac
and said tip; said tip having openings or side holes in
communication with said containment envelope within said sac;
said sac capable of eluting one or more therapeutic agents that
elute through said sac in response to a stimulus when biologically
active cells for containing one or more therapeutic agents are
optionally disposed in said containment envelope.
Appeal Br. 26.
REJECTIONS
1. The Examiner rejects claim 31 under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement.
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Application 11/256,362
2. The Examiner rejects claims 30 and 31 under 35 U.S.C. § 112, second
paragraph, as indefinite.
3. The Examiner rejects claims 8, 11, 12, 15, 17—22, 29, and 30 under
35 U.S.C. § 102(e) as anticipated by Herweck.3
4. The Examiner rejects claims 8, 9, 11, 12, 15-18 and 22 under 35 U.S.C.
§ 102(b) as anticipated by Valli.4
5. The Examiner rejects claims 8, 10-12, 15-22, and 30 under 35 U.S.C.
§ 103(a) as unpatentable over Bae5 in view of Koenig.6
6. The Examiner rejects claim 31 under 35 U.S.C. § 103(a) as unpatentable
over Valli in view of Herweck or Jacobs.7
DISCUSSION
Written Description
With respect to claim 31, the Examiner finds,
The “sac” having a diameter of “approximately 2-5 mm” lacks
original support in that only the stent was originally disclosed as
having this diameter; see paragraph [0060] of the present
specification. Furthermore the “sac” at this diameter would have
to be capable of allowing transfer of nutrients from the
surrounding medium to the cells and the “sac” would have to
form a containment envelope.
Final Act. 2.
Appellant argues that the Specification either explicitly or implicitly
discloses that the sac has a diameter of approximately 2—5 mm because:
3 Herweck et al., US 6,955,661 Bl, iss. Oct. 18, 2005.
4 Valli, US 4,437,856, iss. Mar. 20, 1984.
5 Bae et al., US 5,262,055, iss. Nov. 16, 1993.
6 Koenig, US 4,084,588, iss. Apr. 18, 1978.
7 Jacobs, US 3,794,026, iss. Feb. 26, 1974.
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Appeal 2015-005844
Application 11/256,362
Figure 4 illustrates a stent 11 enclosing a sac 30. The
specification states that “[t]he diameter of the collapsed stent can
be approximately 2-5 mm.” (| [0060].) The specification further
states that the sac (reservoir) may reside in a stent (| [0068]).
Therefore, the specification clearly provides support for “the sac
having a diameter of approximately 2-5 mm” because the sac can
be enclosed within the stent.
Appeal Br. 14.
“Adequate written description means that the applicant, in the
specification, must ‘convey with reasonable clarity to those skilled in the art
that, as of the filing date sought, he or she was in possession of the [claimed]
invention.’” Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1379
(Fed. Cir. 2009) (citation omitted) (brackets in original), reh ’g en banc
denied Sept. 18, 2009. We agree with the Examiner that the Specification
does not convey with reasonable clarity that Appellant was in possession of
a device as claimed at the time the application was filed because the
Specification does not clearly disclose, either explicitly or implicitly, a sac
having a diameter of approximately 2—5 mm. The Specification does
disclose that the stent has a diameter of approximately 2—5 mm in a
collapsed state, and the Specification separately discloses that Figure 4
shows a stent enclosing a sac. See Spec. ^fl[ 60, 63. However, we are not
aware of any disclosure regarding the dimensions of the stent in its expanded
state or whether the stent depicted in Figure 4 is in a collapsed or expanded
state. Thus, it is unclear whether the sac in Figure 4 is depicted in relation to
a collapsed stent or an expanded stent. For this reason, we agree that the
Specification does not support the claimed sac having a diameter of
approximately 2—5 mm with reasonable clarity, and we sustain the rejection
of claim 31 under 35 U.S.C. § 112, first paragraph.
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Appeal 2015-005844
Application 11/256,362
Indefiniteness
The Examiner finds that claims 30 and 31 are indefinite because the
language ‘“the surrounding medium’ lacks antecedent basis and it is unclear
whether this limitation refers to the porous sac, the space within the porous
sac but outside the cells, or the space outside the porous sac.” Final Act. 3.
In response to Appellant’s arguments, the Examiner proposes that the claim
language be amended to read “medium surrounding the sac.” Ans. 4. In
reply, Appellant indicates that the claim will be amended “as indicated if it
is required for allowance.” Reply Br. 3. For this reason, we will sustain the
rejection of claims 30 and 31 under 35 U.S.C. § 112, second paragraph.
Anticipation: Herweck
With respect to independent claims 8 and 30, the Examiner finds that
Herweck discloses a catheter and porous sac as claimed, and more
specifically, the Examiner finds that “the tip end as claimed is the portion of
the catheter touching extensible member (12) (it has to have side holes in it
as required by the present claim language).” Final Act. 4 (citing Herweck
Figs. 1, 2, 12; col. 7,11. 30-54; col. 14,11. 25—57). The Examiner also finds
that “the tip end includes side holes so it is not limited to the edge of the
catheter, and the claims do not require that the entire tip end including the
edge [is enclosed by a porous sac].” Final Act. 9.
We are persuaded of reversible error by Appellant’s argument that the
rejection relies on an unreasonably broad interpretation of the claim.
Specifically, we agree with Appellant that the broadest reasonable
interpretation of the claim consistent with the Specification requires that the
most distal portion, or end, of the catheter is surrounded by the porous sac.
Appeal Br. 16—18. We agree that the plain meaning of the words in the
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Application 11/256,362
claim would indicate that the distal-most edge of the catheter is enclosed by
the porous sac, and this interpretation is consistent with the Specification,
which only depicts the porous sac enclosing the distal edge of the catheter.
See Figs. 7—9. Because the Examiner erred in interpreting the claim and
because Herweck clearly does not disclose a sac enclosing the distal-most
portion of the catheter (see Herweck Figs. 1, 2, 12), we do not sustain the
rejection of claims 8, 11, 12, 15, 17—22, 29, and 30 as anticipated by
Herweck.
Anticipation: Valli
The Examiner relies on the same erroneous interpretation of the
claims in finding that Valli anticipates claims 8, 9, 11, 12, 15—18, and 22.
Final Act. 5—6, 9-10 (citing Valli Fig. 1; Abstract). For the reasons
discussed above and because Valli clearly does not disclose a sac enclosing
the distal-most portion of the catheter (see Valli Figs. 1—4), we do not
sustain the rejection of claims 8, 9, 11, 12, 15—18, and 22 as anticipated by
Valli.
Obviousness: Bae and Koenig
With respect to independent claims 8 and 30, the Examiner finds,
inter alia,
Bae et al meets the claim language where the catheter as claimed
is the tubing (13) and of Bae et al, the tip end as claimed is the []
portion of needle (27) within the device (20) (see Figure 7 and
column 5, lines 14 et seq.), the port end as claimed is the syringe
end adjacent piston (29), the porous sac as claimed is the pouch
(10), and the biologically active cells as claimed are the islets
(15) that are tissue cells of islets of Langerhaus (see column 2,
lines 1-8).
Final Act. 6.
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We are persuaded of error in the rejection at least because we agree
with Appellant that the Examiner has not shown the alleged porous sac 10 of
Bae is disposed about and encloses the tip end of the needle 27. Appeal
Br. 22; see also Bae Figs. 7. In fact, the rejection does not specifically
address this claim requirement and we see no indication in the rejection or
Bae’s disclosure persuading us that such would have been obvious. We also
see no indication that Koenig addresses this deficiency. Accordingly, we do
not sustain the rejection of claims 8, 10-12, 15—22, and 30 over Bae in view
of Koenig.
Obviousness: Valli and Herweck or Jacobs
Claim 31 is directed to a medical device including a catheter and a
porous sac “radially disposed and enveloping the intravascular tip end” of
the catheter. This claim requirement is substantially the same as the
limitations of claim 8 addressed above, and the Examiner relies on the same
findings with respect to Valli addressed above. We are persuaded that the
Examiner erred in rejecting claim 31 for the reasons discussed previously,
i.e. that the Examiner has relied on an unreasonably broad interpretation of
the claims. Thus, we do not sustain the rejection of claim 31.
CONCLUSION
For the reasons set forth above, we conclude as follows.
We AFFIRM the rejection of claim 31 under 35U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
We AFFIRM the rejection of claims 30 and 31 under 35 U.S.C. § 112,
second paragraph, as indefinite.
We REVERSE the rejection of claims 8, 11, 12, 15, 17—22, 29, and 30
under 35 U.S.C. § 102(e) as anticipated by Herweck.
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We REVERSE the rejection of claims 8, 9, 11, 12, 15-18 and 22
under 35 U.S.C. § 102(b) as anticipated by Valli.
We REVERSE the rejection of claims 8, 10-12, 15-22, and 30 under
35 U.S.C. § 103(a) as unpatentable over Bae in view of Koenig.
We REVERSE the rejection of claim 31 under 35 U.S.C. § 103(a) as
unpatentable over Valli in view of Herweck or Jacobs.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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