Ex Parte Gerrans et al

Patent Trial and Appeal Board

Oct 11, 2017

14033181 (P.T.A.B. Oct. 11, 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.
14/033,181 09/20/2013 Lawrence J. Gerrans 04530-P0002H 5664
24126 7590 10/13/2017
ST. ONGE STEWARD JOHNSTON & REENS, LLC
986 BEDFORD STREET
STAMFORD, CT 06905-5619
EXAMINER
FLICK, JASON E
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
10/13/2017 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):
patentpto@ ssjr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LAWRENCE J. GERRANS and ERHAN H. GUNDAY
Appeal 2016-001996
Application 14/033,181
Technology Center 3700
Before MICHAEL L. HOELTER, JEFFREY A. STEPHENS, and
ERIC C. JESCHKE, Administrative Patent Judges.
JESCHKE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Lawrence J. Gerrans and Erhan H. Gunday (“Appellants”)1 seek
review under 35 U.S.C. § 134(a) of the Examiner’s decision, as set forth in
the Final Office Action dated December 15, 2014 (“Final Act.”), and as
further explained in the Advisory Action dated March 6, 2015, rejecting
claims 1—4 and 6—35. The Examiner objects to claim 5 but indicates that it
would be allowable if rewritten in independent form. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify Sanovas, Inc. as the real party in interest.
Appeal Br. 2.
Appeal 2016-001996
Application 14/033,181
BACKGROUND
The disclosed subject matter “relates to methods and systems for
delivering therapeutic and diagnostic agents to specific cellular locations
within and adjacent to bodily tissues and cavities.” Spec. 11. Claims 1 and
10 are independent. Claim 1 is reproduced below, with emphasis added and
with bracketed letters added to identify each clause:
1. A method of extravasated delivery of a
therapeutic and/or diagnostic agent to tissue,
comprising the steps of:
[a] inserting a catheter into a bodily cavity,
said catheter comprising
a first balloon;
a second balloon; and
a third balloon positioned between the
first and second balloons and having a wall
with an abrasive outer surface;
[b] inflating the first and second balloons to
create a chamber between the first balloon and the
second balloon, wherein the boundaries of the
chamber are defined by an inner surface of the
cavity wall and the catheter;
[c] stimulating a flow of blood cells by
repeatedly inflating and deflating the third balloon
by supplying fluid to the third balloon such that
the abrasive outer surface abrades tissue in the
bodily cavity as the third balloon is repeatedly
inflated and deflated; and
[d] delivering the therapeutic and/or
diagnostic agent to the chamber and external of the
third balloon after stimulating the flow of blood
cells.
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Application 14/033,181
EVIDENCE RELIED ON BY THE EXAMINER
Rishton US 3,720,199 Mar. 13, 1973
Wolinsky US 4,824,436 Apr. 25, 1989
Hart US 5,868,708 Feb. 9, 1999
Rosenthal US 2003/0114791 Al June 19, 2003
Kramer US 2006/0135984 Al June 22, 2006
Lary US 2006/0189930 Al Aug. 24, 2006
Smithrud US 2007/0027075 Al Feb. 1,2007
Zadno-Azizi US 2007/0060942 A2 Mar. 15,2007
Goldman US 2008/0208118 Al Aug. 28, 2008
LePivert US 2008/0300571 Al Dec. 4, 2008
Wellman US 7,611,484 B2 Nov. 3, 2009
Petricoin, III US 2010/0074895 Al Mar. 25, 2010
Golzarian US 2011/0082427 Al Apr. 7,2011
Sih US 8,052,668 B2 Nov. 8,2011
Bastid US 2011/0293629 Al Dec. 1,2011
Meric A. Altinoz et al., Noscapine and Diltiazem Augment Taxol and
Radiation-Induced S-Phase Arrest and Clonogenic Death of C6 Glioma In
Vitro, 65 Surgical Neurology 478-485 (2006) (hereinafter “Altinoz”).
REJECTIONS
1. Claims 1, 2, 7, 10, 11, 14, 15, and 20 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Lary and Rosenthal.
2. Claims 3, 4, 21, and 22 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Lary, Rosenthal, and Hart.
3. Claims 6, 12, 16, and 17 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Lary, Rosenthal, and Rishton.
4. Claims 8 and 13 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Lary, Rosenthal, and Zadno-Azizi.
5. Claims 18, 33, and 34 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Lary, Rosenthal, and Goldman.
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Application 14/033,181
6. Claim 9 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Lary, Rosenthal, and Sih.
7. Claim 19 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Lary, Rosenthal, and Wellman.
8. Claims 23, 31, and 32 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Lary, Rosenthal, and Golzarian.
9. Claim 24 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Lary, Rosenthal, and LePivert.
10. Claim 25 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Lary, Rosenthal, and Smithrud.
11. Claim 26 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Lary, Rosenthal, and Kramer.
12. Claim 27 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Lary, Rosenthal, and Altinoz.
13. Claims 28 and 30 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Lary, Rosenthal, and Bastid.
14. Claim 29 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Lary, Rosenthal, and Petricoin, III.
15. Claim 35 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Lary, Rosenthal, and Wolinsky.
DISCUSSION
Appellants argue the patentability of the two independent claims in
Rejection 1 as a group and do not separately argue any dependent claims.
Appeal Br. 6—12. We select independent claim 1 as representative, with the
remaining claims in Rejection 1 standing or falling with claim 1. See 37
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Application 14/033,181
C.F.R. § 41.37(c)(l)(iv) (2014). Appellants do not present any additional
arguments for the patentability of dependent claims 3, 4, 6, 8, 9, 12, 13, 16—
19, and 21—35, at issue in Rejections 2 through 15. Appeal Br. 12.
Accordingly, the outcome of this appeal turns on our analysis of the
rejection of independent claim 1.
For claim 1, the Examiner relied on Lary for certain limitations (Final
Act. 3—4), but stated that “Lary does not specifically disclose the process of
inflating and deflating the third balloon is repeated” {id. at 4). See also
Appeal Br. 14 (Claims App.) (clause c). The Examiner found, however, that
Rosenthal teaches “an apparatus and method which utilizes a balloon
catheter for drug delivery to tissue at a desired location” and “further
discloses that the balloon (figures 7, 7a, and 7b; item 15) may be repeatedly
inflated and deflated in order to deliver a drug (figure[s] 7a and 7b, item 16)
to a specific tissue location.” Final Act. 4 (citing Rosenthal Tflf 46, 67).
According to the Examiner, it would have been obvious for one of ordinary
skill in the art at the time of the invention
to modify the method taught by Lary, with the method step of
repeatedly increasing and decreasing the fluid pressure within
the chamber by at least partially inflating and at least partially
deflating the third balloon, as taught by Rosenthal, in order to
provide increased efficiency and effectiveness of drug delivery
by allowing for a means to ensure proper and sufficient drug
saturation within treated tissue before and after a treatment
procedure.
Id.
First, Appellants state that claim 1 is “not [an] apparatus claim[]
reciting structure that performs a particular function, which may be
anticipated by prior art that simply discloses the claimed structure if it is
capable of performing the recited function,” but rather, is a “method claim[],
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Application 14/033,181
which recite[s] specific method steps.” Appeal Br. 6. Appellants then recite
clauses c and d in claim 1 (emphasizing the language in italics above), and
argue that “while the Office Action identifies various disclosures concerning
inflation/deflation, drug delivery, and abrasion, it does not address these
specific steps.” Id. at 6—7.
To the extent Appellants contend that the Examiner has failed to
establish a prima facie case of obviousness as to clauses c and d, we
disagree. Below, we provide our understanding of the modified process of
Lary and Rosenthal relied on by the Examiner.
As to clause a, we understand the Examiner to rely on the process
shown in Figure 7 of Lary, as modified by the presence of abrasive surface
231 shown in Figure 8 of Lary (to address the “abrasive outer surface”
limitation). See Final Act. 3 (paragraph beginning “inserting a catheter”), 4
(“Lary discloses the third balloon (figures 7 and 8, item 128/228) has a wall
with an abrasive outer surface (figure 8, item 231).”). As to clause b, we
understand the Examiner to rely on the process described in, for example,
paragraphs 55 and 56 of Lary, which discuss Figure 7. See Final Act. 3.
As to clause c, we understand the Examiner to rely on the process of
Lary, as modified by certain teachings of Rosenthal. Specifically, in the
modified process, the relied-upon structures of Lary (as discussed regarding
clauses a and b) would be operated by repeatedly inflating and deflating (as
taught by Rosenthal Tflf 46, 67) the identified “third balloon” 128/228 (in
Lary, Figures 7 and 8, respectively). See Final Act. 4 (“It would have been
obvious to one of ordinary skill in the art at the time of the invention to
modify the method taught by Lary, with the method step of repeatedly
increasing and decreasing the fluid pressure within the chamber by at least
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Application 14/033,181
partially inflating and at least partially deflating the third balloon, as taught
by Rosenthal. . . We understand the Examiner to take the position that,
while repeatedly inflating and deflating the identified “third balloon,” the
identified “abrasive outer surface” (element 231 of Lary) would—based on
its location on the “third balloon”—“abrade[] tissue in the bodily cavity” and
thereby “stimulate^ a flow of blood cells” as recited in clause c. See Final
Act. 4; Ans. 16—17 (“It is clear that the repeated inflating and deflating of
the balloon is not what would stimulate the flow of blood cells, but the
abrasive outer surface of the balloon which actually abrades the tissue.”).
As to clause d, we understand the modified process to deliver agent
with each inflation step for each cycle of inflating and deflating. See Ans.
17 (“[T]he [EJxaminer has relied upon the prior art to Rosenthal to teach the
method step of repeatedly inflating and deflating a balloon in order to
facilitate the delivery of a drug”); see also Final Act. 4 (“Rosenthal further
discloses that the balloon (figures 7, 7a, and 7b; item 15) may be repeatedly
inflated and deflated in order to deliver a drug (figure[s] 7a and 7b, item 16)
to a specific tissue location.”); Final Act. 4 (concluding that one of ordinary
skill in the art would have modified Fary with Rosenthal “in order to provide
increased efficiency and effectiveness of drug delivery by allowing for a
means to ensure proper and sufficient drug saturation within treated tissue
before and after a treatment procedure” (emphasis added)). For the
“stimulating the flow of blood cells” limitation in clause d, we understand
the Examiner to rely on a certain inflation step (for example, at a time t),
which would include (1) abrasion of tissue and thus stimulation of a flow of
blood cells (relied upon to address clause c) and (2) delivery of an agent (not
relied upon to address clause d). For the “delivering the therapeutic and/or
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Application 14/033,181
diagnostic agent. . . after stimulating the flow of blood cells” in clause d, we
understand the Examiner to rely on a later inflation step (for example, at
time t which would again include (1) abrasion of tissue and thus
stimulation of a flow of blood cells (not relied upon to address clause c) and
(2) delivery of an agent (relied upon to address clause d). See Ans. 17 (“In
this light, the limitation of ‘repeatedly inflating and deflating’ could be met
simply by two inflation/deflation cycles.”).
For these reasons, we determine that the Examiner provided sufficient
explanation so that Appellants were “properly notified and able to respond.”
Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007), quoted in In re Jung,
637 F.3d 1356, 1362 (Fed. Cir. 2011). Further, we do not understand the
Examiner to have rejected claim 1 based on a determination that the relied-
upon structures are merely capable of performing the recited steps.
Second, Appellants identify certain statements in the Office Action,
and argue that the Examiner is “essentially omitting parts of’ clause c
because “[ujnless the balloon is inflated and deflated, the abrasive outer
surface would not come into contact with the tissue and abrade it thereby
stimulating the flow of blood cells.” Appeal Br. 7—8. Appellants argue that
the Examiner “appears to be parsing out [clause c] into two separate steps of
‘stimulating a flow of blood cells’ and ‘repeatedly inflating and deflating the
third balloon.’” Id. at 10. According to Appellants, “a person of skill in the
art would not understand the step of ‘stimulating a flow of blood cells by
repeatedly inflating and deflating’ the balloon as being two separate method
steps.” Id. at 11.
We are not apprised of error by the Examiner based on this argument.
Clause c requires three causally linked events: (1) a “third balloon” being
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“repeatedly inflated and deflated” causes (2) an “abrasive outer surface” to
“abrade[] tissue,” which causes (3) “stimulating a flow of blood cells.” See
Ans. 16 (“With regards to the step of ‘stimulating a flow of blood cells,’ the
currently recited claim limitation indicates this is achieved ‘by repeatedly
inflating and deflating the third balloon by supplying fluid to the third
balloon such that the abrasive outer surface abrades tissue in the bodily
cavity . . . Appeal Br. 7—8 (“Unless the balloon is inflated and deflated,
the abrasive outer surface would not come into contact with the tissue and
abrade it thereby stimulating the flow of blood cells.”). Contrary to
Appellants’ argument, however, the Examiner need not identify a single
prior art reference that alone discloses all three events in clause c. Cf. Reply
Br. 2 (arguing that “the Examiner does not cite any prior art in which the
flow of blood cells is stimulated by repeatedly inflating and deflating a
balloon”). As discussed above, we understand the Examiner to rely on Lary
as modified by Rosenthal, rather than Lary alone, to address clause c. See In
re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references.”).
As to the statements identified by Appellants,2 we understand the
Examiner to be discussing how abrasion of tissue—even if provided by
moving a balloon along the tissue surface (see Final Act. 4 (discussing Lary
2 In the statements identified, the Examiner stated (1) that “the
repeated inflating and deflating of the balloon is not what would stimulate
the flow of blood cells, but the abrasive outer surface of the balloon” (Final
Act. 17) and (2) that Lary discloses the “step of abrading tissue (simulating a
flow of blood cells)... by contacting the tissue with the abrasive surface
when the third balloon is inflated” (id. at 18).
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1 57)) rather than inflating and deflating a balloon—would still necessarily
lead to stimulating a flow of blood cells. See Ans. 16—17 (“It is clear that
the repeated inflating and deflating of the balloon is not what would
stimulate the flow of blood cells, but the abrasive outer surface of the
balloon which actually abrades the tissue.”), 17—18 (“[WJherein a reference
discloses the terms of the recited method steps, and such steps necessarily
result in the desired and recited effect, that the reference does not describe
the recited effect (i.e.[,] stimulating a flow of blood cells) in haec verba is of
no significance as the reference meets the claim under the doctrine of
inherency.”).
Third, Appellants argue that “[t]he method of delivering a sclerosing
agent to a blood vessel disclosed in Lary is very different from the method
of extravasated delivery of a therapeutic and/or diagnostic agent to tissue of
the present invention.” Appeal Br. 8. Appellants also argue that “Lary does
not disclose repeatedly inflating and deflating the balloon to cause the
abrasive surface of the balloon to abrade tissue” and “[therefore, [Lary]
does not disclose stimulating the flow of blood cells in this wav in order to
facilitate extravasation of a drug subsequently delivered to the target site, as
is recited in the claims.” Id. at 8—9. Appellants argue that “similarly to
Lary, Rosenthal fails to disclose the step of stimulating the flow of blood
cells by repeatedly inflating and deflating the balloon to cause the abrasive
surface of the balloon to abrade tissue, as recited in the claims.” Id. at 9.
Appellants contend that “[t]he balloon i[n] Rosenthal is deflated and
expanded again only to refill the balloon and deliver more drug” and that
“the balloon of Rosenthal does not have an abrasive outer surface and thus,
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Application 14/033,181
the repeated inflation and deflation of the balloon does not and could not
abrade tissue and stimulate the flow of blood cells.” Id. at 9-10.
We are not apprised of error based on this argument. Nonobviousness
cannot be established by attacking references individually when the rejection
is based on a combination of prior art. See Merck, 800 F.2d at 1097. Here,
by arguing that neither Lary nor Rosenthal, alone, teaches all aspects of
clauses c and d, Appellants do not address the rejection as articulated, in
which the Examiner relies on certain combined teachings of the prior art (as
discussed above regarding Appellants’ first argument).
Fourth, Appellants contend that “Rosenthal specifically teaches away
from abrading tissue, by any means, as it can cause restenosis or closing of
the vessel.” Appeal Br. 10 (citing Rosenthal 15).3 According to Appellants,
“Rosenthal teaches away from abrading tissue and instead teaches a gentle
application [of drug] to avoid injury or disruption to the vessel wall.” Id.
(citing Rosenthal ^fl[ 44, 46, 65).
A reference teaches away “when a person of ordinary skill, upon
reading the reference, would be discouraged from following the path set out
in the reference, or would be led in a direction divergent from the path that
was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir.
1994). Evidence concerning whether the prior art teaches away from an
invention must relate to and be commensurate in scope with the claims at
3 Paragraph 5 of Rosenthal provides, inter alia: “The aftermath of
angioplasty in many cases is problematic, due to restenosis, or closing of the
vessel, that can occur from causes including mechanical abrasion and the
proliferation of smooth muscle cells stimulated by the angioplasty
treatment.”
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issue. See MeadWestVaco Corp. v. Rexam Beauty & Closures, Inc., 731
F.3d 1258, 1264—65 (Fed. Cir. 2013); In re Kahn, 441 F.3d 977, 990 (Fed.
Cir. 2006); In re Zhang, 654 F. App’x 488, 490 (Fed. Cir. 2016)
(nonprecedential) (“While a prior art reference may indicate that a particular
combination is undesirable for its own purposes, the reference can
nevertheless teach that combination if it remains suitable for the claimed
invention^ (emphasis added)).
Rosenthal teaches that “mechanical abrasion” during angioplasty can
cause “restenosis” and teaches “delivery of drugs to a desired location within
the body” instead of performing angioplasty. Rosenthal H 2, 5. Although
Rosenthal teaches that “mechanical abrasion” may have disadvantages in
certain contexts, it does not address the use of abrasion with the subsequent
delivery of drugs, as in claim 1. On the current record, we determine that
Rosenthal does not teach away from the claimed invention.
Fifth, Appellants argue that neither Lary nor Rosenthal discloses
clause d (emphasizing the language in italics above). Appeal Br. 11.
Appellants argue that “the device of Lary first delivers the drug to the
chamber between the distal and proximal balloons, and then the drug is
massaged into tissue by moving the middle balloon back and forth or along
the vessel, which may also abrade tissue.” Id. In addition, Appellants argue,
“[similarly, in Rosenthal, the drug is first released from the hydrogel layer
and then the balloon may be deflated, refilled with more drug and
reinflated.” Id. Thus, according to Appellants, “neither reference discloses
the step of delivering an agent ‘after stimulating the flow of blood cells.’”
Id. at 12.
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We are not apprised of error based on this argument. By arguing that
neither Lary nor Rosenthal, alone, teaches all aspects of clause d, Appellants
do not address the rejection as articulated, in which the Examiner relies on
certain combined teachings of the prior art. See Merck, 800 F.2d at 1097.
As discussed above regarding Appellants’ first argument, in the context of
the modified process, clause d would be satisfied by a first inflation step
“stimulating the flow of blood cells” and a second inflation step “delivering
the therapeutic and/or diagnostic agent.” We note that clauses c and d do not
preclude additional stimulation of the flow of blood cells during delivery of
the therapeutic and/or diagnostic agent and also do not preclude additional
delivery of the therapeutic and/or diagnostic agent during stimulation of the
flow of blood cells.
As to Appellants’ arguments that the Examiner failed to address the
“after stimulating the flow of blood cells” limitation in clause d (Appeal Br.
12; Reply Br. 2), for the reasons discussed above regarding Appellants’ first
argument, we determine that the Examiner provided sufficient explanation
so that Appellants were “properly notified and able to respond.” Hyatt, 492
F.3d at 1370, quoted in In re Jung, 637 F.3d at 1362.
For these reasons, we sustain the rejection of independent claim 1 as
unpatentable. Claims 2-4 and 6—35 fall with claim 1.
DECISION
We affirm the decision to reject claims 1—4 and 6—35.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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