Ex Parte Janzig et al

Board of Patent Appeals and Interferences

Apr 29, 2010

10731699 (B.P.A.I. Apr. 29, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte DARREN A. JANZIG, CARL D. WAHLSTRAND,
ROBERT M. SKIME, MARK S. LENT,
KEITH A. MIESEL, and JAMES E. CABAK
____________________

Appeal 2009-005345
Application 10/731,699
Technology Center 3700
____________________

Decided: April 30, 2010
____________________

Before: WILLIAM F. PATE III, KEN B. BARRETT, and
FRED A. SILVERBERG, Administrative Patent Judges.

PATE III, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1,
3-11, 13-15 and 17-25. App. Br. 3. We have jurisdiction under 35 U.S.C.
§ 6(b).
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The claims are directed to implantable medical device (“IMD”).
Claim 1, reproduced below, is illustrative of the claimed subject matter:
1. An implantable medical device comprising:

at least two modules, each of the modules comprising a
respective one of at least two housings;

a coupling module coupled to each of the modules, the
coupling module defining at least one lumen between the
housings; and

an overmold that at least partially encapsulates each of
the housings and the coupling module,

wherein the coupling module permits motion of the two
modules along at least one axis of motion.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Lynch
Hirschberg
Meltzer
Wahlstrand
US 4,934,368
US 5,312,440
US 5,645,586
US 7,212,864 B2
Jun. 19, 1990
May 17, 1994
Jul. 8, 1997
May 1, 2007

REJECTIONS
Claim 25 stands rejected under 35 U.S.C. § 102(b) as being
anticipated by Lynch. Ans. 3.
Claims 7-11, 14, 15, 17 and 20-23 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by Hirschberg. Ans. 3.
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Claims 1, 3-6 and 24 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Lynch. Ans. 3.
Claims 13, 18 and 19 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Hirschberg1. Ans. 4.
Claims 7, 8, 19 and 25 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Meltzer. Ans. 4.
Claim 1 stands rejected under the judicially-created doctrine of
obviousness-type double patenting as being unpatentable over claim 1 of
U.S. Patent number 7,212,864. Ans. 5.

OPINION
The rejection of claim 25 as being anticipated by Lynch is reversed.
Appellants contend that the Examiner’s finding that Lynch inherently
discloses hermetic sealing of the coupling module because Lynch discloses
an “environmental” seal within the body, is erroneous because an
“environmental” seal within the body, does not necessarily require
“hermetic” sealing. App. Br. 7-10.
“To establish inherency, the extrinsic evidence must make clear that
the missing descriptive matter is necessarily present in the thing described in
the reference. Inherency, however, may not be established by probabilities
or possibilities. The mere fact that a certain thing may result from a given set
of circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed.
Cir. 1999) (citations and internal quotations omitted).
Appellants’ Specification discusses the ability to provide protection
within the body without necessarily providing a “hermetic” seal. Spec. p. 14,

1 Claim 12 has been cancelled. App. Br. 14.
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para. [0061]. Similarly, Lynch describes certain structures 6 as
“hermetically” sealed, while describing other seals 13, 14 as
“environmental.” Cf. Lynch col. 6, ll. 20-22, col. 7, ll. 46-47. Lynch goes on
to say that seals 13, 14 are exceptionally resistant against moisture, but
Lynch does not describe these seals as “hermetic.” Col. 8, ll. 1-2. The ability
to exclude “moisture” does not necessarily make a seal “hermetic.” There is
no evidence to support the Examiner’s contention that every seal within the
body must be hermetic. Ans. 5-6, 7. This finding is contrary to both the
teachings of the Specification and the prior art. If the structures within seals
13, 14 required a less than hermetic level of protection from the
environment, hermetic sealing of those structures would not be necessary.
Since Lynch is silent regarding that subject we must conclude that the
hermetic sealing of Lynch’s leads 3, read as the claimed “coupling module”
is not necessarily present, and therefore not an inherent feature of Lynch as
was found by the Examiner.
Appellants’ and the Examiner’s discussion of “teaching away” (App.
Br. 8; Ans. 5) is not relevant to a rejection under 35 U.S.C. § 102(b). See
Seachange Intern., Inc. v. C-COR, Inc. 413 F.3d 1361, 1380 (Fed. Cir.
2005). Nor is Appellants’ and the Examiner’s discussion of the reasons why
or why not one would incorporate hermetic seals into Lynch’s device. Ans.
6; App. Br. 10.

The rejection of claims 7-11, 14, 15, 17 and 20-23 as being anticipated by
Hirschberg is reversed.
For reasons similar to those discussed above regarding the rejection of
claim 25 as being anticipated by Lynch, the Examiner also erred by finding
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that, due to its presence in the body, Hirchberg’s lead 9, read as the claimed
“coupling module,” was inherently “hermetically fixed” to the housing 15
and the defibrillator 1, read as the claimed “housings.”

The rejection of claims 1, 3-6 and 24 as being unpatentable over Lynch is
reversed
The Examiner opines that based upon the fact that Lynch’s cuff 2 may
be sealed to the lead 3 with a final dip coat, it would have been obvious to
apply a dip coat to both the case 12 and the lead 3. Ans. 3-4; Lynch col. 8, ll.
32-35. Claim 1 requires that an overmold at least partially encapsulates
“each” of the housing and the coupling module. The Examiner does not
specify what structure of Lynch is regarded as the claimed housings and
coupling modules. Based upon the Examiner’s analysis of claim 25, Lynch’s
case 12 and nerve cuff 2 are read as the claimed modules comprising
respective housings, and leads 3 are read as the claimed “coupling module.”
Thus, to meet the claim Lynch’s dip coat, read as the claimed “overmold”
would need to at least partially encapsulate case 12, nerve cuff 2 and leads 3.
Lynch’s device is designed so that nerve cuffs 2 may be selectively placed at
various distances from the master circuitry case 12. See e.g., Fig. 1.
Additionally, an important feature of Lynch’s invention is the ability to
replace leads without replacing the entire system. Col. 3, ll. 40-51. Providing
a dip coat over Lynch’s case 12, leads 3 and nerve cuff 2 would restrict the
flexibility of Lynch’s system and might prevent the separability of the leads.
Since there would have been no rationale basis to destroy this functionality
of Lynch, the Examiner has failed to articulate any reason with a rationale
underpinning to support the conclusion of obviousness. App. Br. 16-18. See
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In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness), cited with approval in KSR International Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).

The rejection of claims 13, 18 and 19 as being unpatentable over Hirschberg
is reversed.
Contrary to the Examiner’s finding regarding the rejection of claim 7
as being anticipated by Hirschberg, in the rejection of claims 13, 18 and 19
the Examiner indicates that hermetic fixation is not disclosed by Hirschberg
but that it would have been an obvious variant. Ans. 4. Claims 13, 18 and 19
do not further limit features related to hermetic fixation. Only parent claim 7
contains this limitation. Neither the Examiner nor the Appellants adequately
addresses the issue of whether hermetic fixation would have been an obvious
modification to Hirschberg. App. Br. 11-12, 15-16; Ans. 8. We will not
assume that the Examiner intended claim 7 to be rejected in the alternative
under 35 U.S.C. § 103(a) as being unpatentable over Hirschberg. Appellants
have not had a fair opportunity to react to such a rejection. We therefore do
not reach the issue of whether hermetic fixation would have been an obvious
modification to Hirschberg’s device. Instead, we reverse the rejection of
claims 13, 18 and 19 as being unpatentable over Hirschberg because the
examiner erred in determining the scope and content of the prior art with
respect to parent claim 7, as indicated above.

Regarding the rejections discussed below, we find that the following
enumerated facts are supported by at least a preponderance of the evidence.
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Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the
general evidentiary standard for proceedings before the Office).
1. Rigidity of an implantable medical device (“IMD”) housing is a problem
perceived by the inventors of the claimed subject matter. Spec. 2, para.
[0004].
2. Meltzer discloses an implantable medical device that is adapted to
conform to the contour of an implantation site and/or to flex in
compliance with movement at such an implantation site. Col. 1, ll. 6-10.
Meltzer acknowledges the desirability of manufacturing low-profile
implants. Col. 1, ll. 56-57.
3. Appellants recognize that in order to avoid potentially harmful
interactions between the components of an IMD and bodily fluids, IMD
housings are typically hermetically sealed. Spec. 2, para. [0004].
4. Meltzer discloses an IMD housing 38, for a defibrillator or other device.
Col. 3, ll. 5-9, 55-60. The housing 38, which may be constructed from a
biocompatible material such as titanium or stainless steel, includes three
segments 23, 24, 25 interconnected by, and pivotable about, hinge axes
27, 28. The hinge axes are constructed so as not to compromise the
integrity of the enclosure seal, which is typically made by welding the
half shells together to form a hermetic seal. Col. 3, ll. 19-51; fig. 2.
5. According to one embodiment described by Meltzer, a hinge arrangement
including a transverse cylinder 34 within a transverse channel 35 is
employed to electrically connect segments 31, 32 of the housing while
maintaining the integrity of the housing seal. Col. 3, l. 65 – col. 4, l. 35;
fig. 3.
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6. In an alternative embodiment Meltzer discloses that an encapsulated
interconnect cable 43, such as a ribbon cable, may be used at the hinge
axis to mechanically and electrically interconnect the segments. Col. 4, ll.
29-30; fig. 4.
7. Meltzer further discloses that either the housing segments or the entire
housing may be coated with a biocompatible polymer, such as silicone
rubber for sealing the device. Col. 4, ll. 45-48
8. In another alternative embodiment Meltzer discloses that a highly
compliant flexible housing 50, 51 can form a sealed enclosure for various
electrical components of the device. Col. 4, ll. 49-60; fig. 5.
9. Meltzer teaches that it is known to include a battery 55 in an IMD.

The rejection of claims 7, 8, 19 and 25 as being unpatentable over Meltzer is
affirmed.
Regarding the Examiner’s rejection of claims 7, 8, 19 and 25, the
Examiner incorrectly found that Meltzer fails to disclose “a coupling module
that defines at least one lumen between the first and second housings.” Ans.
4-5. It is readily apparent from Meltzer that hinge 33 is a “coupling module”
that defines, by way of transverse cylinder 34, “at least one lumen between
the first and second housings,” 31, 32, wherein at least one of the housings
contains control electronics. Facts 4 and 5. Meltzer’s encapsulated
interconnect, or ribbon, cable would also define a “lumen between the first
and second housings.” Fact 6. Both the embodiment depicted in Figure 3 of
Meltzer and the embodiment depicted in Figure 4 of Meltzer would therefore
have anticipated claim 25. Since anticipation is the epitome of obviousness
the Examiner did not err in concluding that the subject matter of claim 25
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would have been obvious. In re Baxter Travenol Labs 952 F.2d 388, 390-91
(Fed. Cir. 1991).
Appellants argue claims 7, 8 and 19 as a group. Claim 7 is
representative. 37 C.F.R. § 41.37(c)(1)(vii). Appellants’ conclusion that the
rejection of claim 7 should be withdrawn because the Examiner failed to
identify metal as a known material in the prior art is unpersuasive. It is
readily apparent from Meltzer that metals, such as titanium and stainless
steel are known in the art. See Fact 4. As Appellants point out, Meltzer only
describes these materials as materials that may be used for constructing the
housing 38 and does not describe a specific embodiment wherein those
materials are used in the connector member, hinge 33. Including a metal
defining a lumen in the connecting member is a modification that would
have been obvious to one having ordinary skill in the art. While Meltzer
prefers polymetric compositions for the connector member, one of ordinary
skill in the art would recognize that known metallic compositions may also
be used in the connecting member in order to, for example, to physically
protect or electronically shield, the cables contained therein. Thus the
Examiner did not err in concluding that the subject matter of claim 7 would
have been obvious to one having ordinary skill in the art.

The rejection of claim 1 under the judicially-created doctrine of
obviousness-type double patenting is reversed.
Appellants correctly point out that, if the Examiner has assessed the
differences between the claims alleged to be patentably indistinct, those
findings have not been made explicit in the Examiner’s rejection. App. Br.
21-22; Ans. 5. Under that facet of the doctrine of double patenting, we must
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direct our inquiry to whether the claimed invention in the application for the
second patent would have been obvious from the subject matter of the
claims in the first patent, in light of the prior art. Carman Industries Inc. v.
Wahl, 724 F.2d 932, 940 (Fed. Cir. 1983). The examiner bears the initial
burden of factually supporting any prima facie conclusion of obviousness.
The key to supporting any prima facie conclusion of obviousness under 35
U.S.C. § 103 is the clear articulation of the reason(s) why the claimed
invention would have been obvious. The Court in KSR International Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007) noted that the analysis supporting a
rejection under 35 U.S.C.§ 103 should be made explicit. The Federal Circuit
has stated that “rejections on obviousness grounds cannot be sustained by
mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with
approval in KSR, 550 U.S. at 418. Since the Examiner has not made of
record any analysis, the Examiner has failed to articulate any reasoning with
a rational underpinning to support the legal conclusion of obviousness. Ans.
5.

Pursuant to our authority under 37 C.F.R. § 41.50(b), we enter a new
ground of rejection of claims 1, 3-5, 9, 11, and 21-24 under 35 U.S.C.
§ 102(b) as being anticipated by Meltzer.
Meltzer discloses each and every limitation of claims 1, 3-5, 9, 11,
and 21-24. Facts 2 and 4-8. Regarding claim 1, as noted above, Meltzer’s
encapsulated interconnect, or ribbon, defines a “lumen between the
housings.” See Fact 6. Both the biocompatible polymer coating, or the sealed
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enclosure, are reasonably read as “an overmold that at least partially
encapsulates each of the housings and coupling module.” See Facts 7 and 8.
Regarding claims 3, 4, 9, 11, 23, and 24 ribbon cables, an example of which
is illustrated in Figure 5, although not discussed in detail by Meltzer, are
known to define “at least two lumens” having a “circular cross-sectional
shape” and “a conductor passing through the lumen.” Regarding claim 22,
when used as a hinge, they include “at least one bend.” Regarding claim 5, a
defibrillator is, or includes, “a control module containing electronic
components.” See Fact 4. Regarding claim 21, Meltzer discloses the
coupling module “fixedly coupled to portions of the housings that are
adjacent one another.” Fact 4.

Pursuant to our authority under 37 C.F.R. § 41.50(b), we enter a new
ground of rejection of claims 6, 17, 18, and 20 under 35 U.S.C. § 103(a) as
being unpatentable over Meltzer.
Regarding claim 6, Meltzer acknowledges the desirability of making
low profile implants and suggests making implants that conform to the
contours of the implantation site. Fact 2. In light of this suggestion, it would
have been obvious to one having ordinary skill in the art to select the
appropriate dimensions to predictably conform to the implantation site.
Thus, providing an IMD with a maximum thickness of between 4 and 8
millimeters would have been obvious to one having ordinary skill in the art.
Regarding claims 17, 18, and 20 Meltzer demonstrates that titanium,
weld joints, and batteries are known in the art. See Facts 4 and 9. It would
have been obvious to one of ordinary skill in the art to select the appropriate
material, fastening method and power supply, respectively. The use of these
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elements amounts to no more than the predictable use of prior art elements
according to their known functions and would have been obvious to one
having ordinary skill in the art.
The Board of Patent Appeals and Interferences is a review body,
rather than a place of initial examination. We have made a rejection above
under 37 C.F.R. § 41.50(b) based on the applied prior art references.
However, we have not reviewed the remaining claims to the extent
necessary to determine whether these claims are unpatentable over the
applied prior art references and other patents cited in the record. We leave it
to the instant Examiner to determine the appropriateness of any further
rejections based on these references.

DECISION
The rejection of claim 25 as being anticipated by Lynch is reversed.
The rejection of claims 7-11, 14, 15, 17 and 20-23 as being
anticipated by Hirschberg is reversed.
The rejection of claims 1, 3-6 and 24 as being unpatentable over
Lynch is reversed.
The rejection of claims 13, 18 and 19 as being unpatentable over
Hirschberg is reversed.
The rejection of claims 7, 8, 19 and 25 as being unpatentable over
Meltzer is affirmed.
The rejection of claim 1 under the judicially-created doctrine of
obviousness-type double patenting is reversed.
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Pursuant to our authority under 37 C.F.R. § 41.50(b), we enter new
grounds of rejection of claims 1, 3-5, 9, 11, and 21-24 under 35 U.S.C. §
102(b) as being anticipated by Meltzer.
Pursuant to our authority under 37 C.F.R. § 41.50(b), we enter new
grounds of rejection of claims 6, 17, 18, and 20 under 35 U.S.C. § 103(a) as
being unpatentable over Meltzer.

FINALITY OF DECISION
Regarding the affirmed rejection(s), 37 C.F.R. § 41.52(a)(1) provides
“Appellant may file a single request for rehearing within two months from
the date of the original decision of the Board.”
In addition to affirming the Examiner's rejections of one or more
claims, this decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b) (2008). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the
Examiner, in which event the proceeding will be remanded to
the Examiner. . . .
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(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same record. . . .
Should Appellants elect to prosecute further before the Examiner
pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
prosecution before the Examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
If Appellants elect prosecution before the Examiner and this does not
result in allowance of the application, abandonment or a second appeal, this
case should be returned to the Board of Patent Appeals and Interferences for
final action on the affirmed rejection, including any timely request for
rehearing thereof.
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) (2007).

AFFIRMED-IN-PART; § 41.50(b)

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