Ex Parte Mongeon et al

Board of Patent Appeals and Interferences

Jul 20, 2012

10663570 (B.P.A.I. Jul. 20, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte LUC R. MONGEON, JESUS CASAS-BEJAR,
H. TOBY MARKOWITZ, DAISY P. CROSS, JANELLE BLUM,
MICHAEL EBERT, and TIMOTHY G. LASKE
__________

Appeal 2011-003497
Application 10/663,570
Technology Center 3700
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 21-24, 26, 29-33, 35-42, and 46-54. We have
jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
Claim 21 is representative of the claims on appeal, and reads as
follows:
21. A medical lead comprising:
a lead body;
a porous electrode mounted on the lead body to deliver electrical
stimulation to a stimulation site within a patient;
a genetic material that causes expression of at least one of a connexin
or a gap-junction by the tissue at the stimulation site, wherein the expression
of the at least one of the connexin or the gap-junction by the tissue at the
stimulation site increases the conductivity of the tissue; and
a chamber body that defines a chamber, the chamber containing a
polymeric matrix that absorbs the genetic material and degrades to elute the
genetic material to tissue at the stimulation site via the porous electrode.

The following ground of rejection is before us for review:
Claims 21-24, 26, 29-33, 35-42, and 46-57 stand rejected under 35
U.S.C. § 103(a) as being rendered obvious by the combination of Soykan,1
Heil,2 and Girouard3 (Ans. 5).
We affirm.
ANALYSIS
We adopt the Examiner’s findings and conclusions as our own, and
highlight the following:
The Examiner relies on Soykan for teaching a system “comprising a
lead for delivering electrical stimulation to a tissue . . . and eluting genetic
material from a polymeric matrix . . . comprising extracellular collagen”

1 Soykan et al., US 6,151,525, issued Nov. 21, 2000.
2 Heil, Jr. et al., US 4,819,662, issued Apr. 11, 1989.
3 Girouard et al., US 2004/0158289 A1, published Aug. 12, 2004.
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(Ans. 5). The Examiner notes that “Soykan does not disclose a separable
chamber that elutes material from a porous electrode or that the genetic
material causes expression of connexin-43 or a gap-junction” (id. at 6).
The Examiner cites Heil for teaching “a lead with a removable
chamber that elutes substances through a porous electrode for the purpose of
providing controlled release of pharmacological agents at the site of
electrical therapy” (id.). The Examiner relies on Girouard for teaching that
expression of connein-43 repairs damaged heart tissue (id.).
The Examiner concludes:
it would have been obvious to one having ordinary skill in the
art at the time the invention was made to modify Soykan’s
invention by providing a lead with a chamber that elutes
substances through a porous electrode for the purpose of
providing controlled release of pharmacological agents at the
site of electrical therapy and providing a cardiac therapy
comprising delivering connexin for the purpose of repairing
damaged heart tissue.

(Id.)
Appellants argue claims 21-24, 26, and 29-33 as a group, of which we
choose claim 21 as representative. Appellants assert that “the Examiner has
failed to establish an apparent reason with a rational underpinning for
modifying Soykan in view of Heil and Girouard, and, thus, failed to
establish a prima facie case of obviousness of claim 21” (App. Br. 8).
Appellants assert that the Examiner’s reasoning that the ordinary artisan
“would have looked to Heil to modify Soykan in order to provide ‘controlled
release of pharmacological agents at the site of electrical therapy’” ignores
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the “fact that the system disclosed by Soykan already provides controlled
release of a genetic material at the site of electrical therapy” (id.).
Appellants argue further that contrary to the Examiner’s finding that
Soykan is silent as to where the polymeric carrier for the genetic material
resides on the electrical stimulation device, Soykan teaches “that genetic
material may be coated on or otherwise incorporated into a carrier, such as
an electrical stimulator capsule or a catheter, and, therefore, Soykan
discloses a carrier configuration” (id. at 8-9). Appellants assert that
“[a]bsent access to Appellant’s disclosure, one having ordinary skill in the
art would not have had any apparent reason to incorporate the electrical
stimulator coating disclosed by Soykan into a chamber of the lead disclosed
by Heil” (id. at 9).
According to Appellants, the “coating disclosed by Soykan differs in
operation from the chamber delivery system disclosed by Heil” (id.).
Appellants further assert that “Heil does not provide any indication that the
porous electrode is advantageous over the coating disclosed by Soykan for
releasing a genetic material, or provides some expected beneficial result over
the coating disclosed by Soykan,” and thus there is no reason to modify
Soykan with Heil (id.). Appellants further assert that Soykan already
discloses an electrical stimulation device that carries genetic material as a
coating, and thus again there is no reason to modify Soykan with Heil (id. at
9-10).
Appellants’ arguments have been carefully considered, but are not
found to be convincing. “The combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
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predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416
(2007).
If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability. For the same
reason, if a technique has been used to improve one device, and
a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond his
or her skill.

Id. at 417.
While holding that some rationale must be supplied for a conclusion
of obviousness, the Supreme Court nonetheless rejected a “rigid approach”
to the obviousness question, and instead emphasized that “[t]hroughout this
Court’s engagement with the question of obviousness, our cases have set
forth an expansive and flexible approach . . . .” Id. at 415. The Court also
rejected the use of “rigid and mandatory formulas” as being “incompatible
with our precedents.” Id. at 419; see also id. at 421 (“Rigid preventative
rules that deny factfinders recourse to common sense, however, are neither
necessary under our case law nor consistent with it.”). The Court thus
reasoned that the analysis under 35 U.S.C. § 103 “need not seek out precise
teachings directed to the specific subject matter of the challenged claim, for
a court can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” Id. at 418; see also id. at 421.

On this record, both Soykan and Heil deliver a therapeutic material to
a patient’s heart tissue using a polymeric carrier (see, e.g., Soykan, col. 11,
ll. 15-21; Heil col. 4, ll. 45-51). The polymeric material of Soykan appears
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to surround the lead (see, e.g., Soykan, Fig. 1), whereas, as found by the
Examiner, the polymeric material of Heil uses a cavity behind a porous
electrode (see, e.g., Heil, col. 4, ll. 45-53). But as both allow for the
therapeutic material to be delivered to the cardiac tissue, we agree with the
Examiner to use a chamber disposed behind a porous lead to place the
polymeric material containing the genetic material to be delivered as taught
by Soykan as both Soykan and Heil teach the lead allows for delivery of the
therapeutic tissue to the cardiac tissue.
Appellants also assert that the drug disclosed by Heil and the genetic
material taught by Soykan “may have different purposes and different
properties,” and thus “there may be different considerations and objectives
for elution of a drug versus elution of a genetic material” (App. Br. 10).
According to Appellants, “[n]either the Heil nor Soykan disclosures provide
reasonable support for asserting that modifying Soykan in view of Heil to
include a matrix that elutes a genetic material to tissue at a stimulation site
via a porous electrode would reasonably be expected to be successful” (id. at
11).
Again, Appellants’ arguments are not convincing. As noted above,
both the lead of Soykan and the lead of Heil allow for delivery of a
therapeutic material from a polymeric matrix to surrounding cardiac tissue.
Thus, the method of delivery of both references is the same—the only thing
that differs is the location of the polymeric matrix, in Soykan it surrounds
the lead, and in Heil it is located behind a porous electrode. Thus, the
ordinary artisan would have had a reasonable expectation that the using the
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structure of Heil, wherein the polymeric material is in a chamber behind a
porous electrode, would allow for delivery of the genetic material of Soykan.
See In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988) (noting that all that
is required is a reasonable expectation of success, not absolute predictability
of success).
Appellants argue further that the Examiner does not “provide any
articulated reasoning for why one having ordinary skill in the art would have
looked to Girouard to modify Soykan” (App. Br. 11). Appellants assert that
the Examiner’s reasoning that the ordinary artisan would have modified
Soykan with Girouard to provide a cardiac therapy to deliver connexin to
repair heart tissue is circular and “lacks a rational underpinning” (id.).
Specifically, Appellants assert that “Girouard does not provide any
indication that connexin is advantageous over the genetic material disclosed
by Soykan, or provides some expected beneficial result over the coating
disclosed by Soykan” (id.).
Appellants assert further that Girouard proposes the use of the genetic
material than Soykan, as Girouard conditions donor cells, prior to
administration to the area to be treated, whereas Soykan discloses that the
cells are converted in vivo (id. at 12). Appellants argue that “[n]either
Soykan nor Girouard provides any indication that expression of connexin,
which takes place ex vivo in the Girouard reference, may be simply
substituted in the in vivo technique disclosed by Soykan, as asserted by the
Examiner” (id. at 13).
Appellants’ arguments are not convincing. Soykan teaches the
delivery of nucleic acids to cardiac tissue, wherein the nucleic acid converts
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noncontracting cells to contracting cells (Soykan, col. 7, ll. 53-63). Girouard
is drawn to combined cell and electrical therapy of cardiac tissue (Girouard,
p. 1, ¶ 8). Girouard teaches that the cells may be conditioned with a
transgene, encoding, for example, contractile proteins, or a connexin, such as
connexin-43 (id. at p. 12, ¶146). Girouard also teaches that the delivery of
the transgene may be accomplished by any means (id. at p. 13, ¶153).
Although Girouard teaches in vitro conditioning of the cells, Soykan teaches
direct delivery of the genetic material to the cardiac tissue in vivo by means
of the polymeric material surrounding the lead. Thus, the ordinary artisan,
reading Soykan, Girouard, and Heil, would understand that any desired
gene, such as the contractile proteins or connexins of Girouard, may be
delivered by the device taught by Soykan and Heil, as Soykan teaches the
direct delivery of genetic material to cardiac tissue in vivo.
As to claim 46, Appellants argue that the Examiner relies on
inherency, reasoning “that ‘[b]ecause Soykan is in effect creating new
contractile tissue around the stimulation device, this inherently creates a new
arbitrary ‘preferred conduction pathway’’” (App. Br. 17). Appellants argue
the fact that a certain characteristic may be present is not sufficient to
support a finding of inherency (id.). Appellants assert that “claim 46
recognizes that delivering a genetic material that causes expression of at
least one of a connexin or a gap-junction by the tissue at the stimulation site
to increase the conductivity of the tissue at the stimulation site can form a
preferential conduction pathway to the bundle of His or a Purkinje fiber by
increasing the conductivity of the tissue relative to other (e.g., adjacent)
tissue through which the stimulation may also traverse” (id. at 18-19).
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Claim 46 is drawn to the lead of claim 21,
wherein the genetic material is adapted to cause expression of at
least one of a connexin or a gap-junction by the tissue at the
stimulation site to increase the conductivity of the tissue at the
stimulation site and create a preferential conduction pathway
between the stimulation site and at least one of a bundle of His
or a Purkinje fiber of a heart of the patient.

As noted by the Examiner (Ans. 12), claim 46 is thus drawn to an apparatus
claim, wherein the function of the genetic material is recited. That is, as
found by the Examiner, “[t]here is no method step of applying the genetic
material to a certain location to create a preferred pathway, but merely a
genetic material adapted to create a preferential conduction pathway” (id.).
As Appellants have not explained how the functional limitation limits the
structure of the apparatus, we affirm the rejection as to claim 46 as well.
As to claims 35-42, Appellants essentially reiterate the arguments
made with respect to claim 21, and as to claim 54, Appellants essentially
reiterate the arguments made with respect to claim 46 (App. Br. 20). Those
arguments are not found to be convincing for the reasons set forth above.

SUMMARY
We affirm the rejection of claims 21-24, 26, 29-33, 35-42, and 46-57
under 35 U.S.C. § 103(a) as being rendered obvious by the combination of
Soykan, Heil, and Girouard.

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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).

AFFIRMED

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