Ex Parte Dent et al

Board of Patent Appeals and Interferences

Jun 11, 2009

10327328 (B.P.A.I. Jun. 11, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte WANDA FAYE DENT,
J. RICHARD GYORY, and MICHAEL JOSEPH GRACE
__________

Appeal 2008-005664
Application 10/327,328
Technology Center 3700
__________

Decided:1 June 11, 2009
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
JEFFREY N. FREDMAN, 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 final rejection of claims 1, 3-5, 8, 12-14, 16, 17, and 21-29. We
have jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2008-005664
Application 10/327,328

STATEMENT OF THE CASE2
The claims are directed to an iontophoretic drug delivery device.
Claims 1, 4 and 16 are representative of the claims on appeal, and read as
follows:
1. A reservoir housing for an iontophoretic drug delivery device
comprising:
a cavity and an interior and exterior surface; said reservoir housing at
least partially formed of a non-conductive material; and
a monolithic conductive element disposed within a portion of said
reservoir housing, the monolithic conductive element integrally formed with
the reservoir housing to provide a liquid and moisture tight interface
between said conductive element and said reservoir housing.

4. A reservoir housing for an iontophoretic drug delivery device
comprising:
a cavity and an interior and exterior surface; said reservoir housing at
least partially formed of a non-conductive material; and
a monolithic conductive element disposed within a portion of said
reservoir housing to provide a moisture tight interface between said
conductive element and said reservoir housing, the monolithic conductive
element further comprising a peripheral portion that extends radially
outwards over the outer surface of said reservoir housing.

16. A reservoir housing for an iontophoretic drug delivery device
comprising:
a cavity and an interior and exterior surface; said reservoir housing at
least partially formed of a plastic, non-conductive material; and
a plastic conductive element plastically bonded within a portion of
said plastic, non-conductive material of said reservoir housing to provide a
moisture tight interface between said plastic conductive element and said

2 The papers considered in deciding this appeal are the Supplemental Appeal
Brief (App. Br.) dated January 16, 2007, and the Supplemental Examiner’s
Answer (Ans.) dated September 24, 2007.
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reservoir housing, said plastic conductive element having a volume
resistivity less than about 10,000 ohms-cm.

The Examiner relies on the following evidence:
Bremer US 4,215,696 Aug. 5, 1980
Jones US 4,911,688 Mar. 27, 1990
Untereker US 5,395,310 Mar. 7, 1995
Wright US 5,499,628 Mar. 19, 1996

We affirm-in-part.

ISSUE (New Matter)
The Examiner find that claims 16, 27 and 28 contain new matter in
their recitation of the phrase “plastically bonded.”
Appellants contend that the term “plastically bonded” is supported by
paragraphs 23, 26 and 28 of the disclosure as filed.
Thus, the issue on appeal is: Have Appellants demonstrated that the
Examiner erred in finding that the phrase “plastically bonded” is not
supported by the disclosure as filed?

FINDINGS OF FACT
FF1 According to the Specification, the “present invention relates to a
transdermal therapeutic agent delivery and sampling device having a
reservoir housing having an electrically conductive element integrally
molded with the generally non-conductive housing.” (Spec. ¶1.)
FF2 The Specification defines “electrotransport” as “the delivery or
extraction of a therapeutic agent (charged, uncharged, or mixtures thereof)
through a body surface (such as skin, mucous membrane, or nails) wherein
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the delivery or extraction is at least partially induced or aided by the
application of an electric potential.” (Id. at ¶2.)
FF3 The Specification teaches:
The present invention provides an electrotransport
reservoir housing having a conductive element integrally
molded within the insulated housing. This integral molding
enables placing the drug reservoir and electrode in electrical
communication with the power source without the need for an
opening in the reservoir housing. Because the molding process
is performed at high heat and pressure, there is very tight, liquid
and moisture impermeable bond between the material forming
the reservoir housing and the conductive element. This results
in a reservoir housing that is essentially a single integral
component with no openings or other passages through the
housing which would require subsequent sealing. By having a
conductive element molded into the housing during
manufacture, it eliminates problems of water and/or moisture
from the drug reservoir contained within the interior of the
reservoir housing leaking through or otherwise coming in
contact with the electrical and/or mechanical components. In
addition, the molded design allows electrical and/or mechanical
connections to be formed as an integral part of the reservoir.

(Id. at ¶23 (emphasis added).)
FF4 The Specification teaches further that the reservoir housing assembly
“may be produced by a multi-shot injection molding process,” wherein
multiple materials are injected into a single mold (id. at ¶26).
FF5 In one embodiment of the Specification, an electrode is placed into the
mold at the start of the molding process (id. at ¶28). Then plastics are
injected into the mold, flowing around the electrode, securing the electrode
at the bottom of the reservoir cavity and sealed within it (id.).
FF6 The Examiner rejects claims 16, 27 and 28 under 35 U.S.C. § 112,
first paragraph, as containing new matter (Ans. 4).
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FF7 The Examiner finds that “‘[p]lastically bonded’ and ‘plastically
sealed’ have not been described in the specification or drawings.” (Id.)
FF8 The Examiner notes that “a skilled artisan would understand the term
‘plastically’, with no description or definition in the specification upon
which to rely, to be a property of the bond, i.e. capable of undergoing non-
reversible deformation.” (Id. at 10.)
FF9 The Examiner finds that “Appellant only has support in the
specification for the molding and bonding together of two plastic materials
but does not have support for ‘plastically bonded.’” (Id.)

PRINCIPLES OF LAW
The disclosure as originally filed need not provide “in haec verba
support for the claimed subject matter at issue,” rather, the disclosure should
convey to one skilled in the art that the inventor was had possession of the
invention at the time of filing. Purdue Pharma L.P. v. Faulding Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000) (citations omitted).

ANALYSIS
Appellants argue that “plastically bonded” is supported by paragraphs
23, 26 and 28 of the instant Specification.
We find that Appellants have the better position. Paragraph 23 of the
Specification discusses bonding in the context of the injection molding
process, and paragraph 28 discusses placing an electrode in the mold before
the injection molding process. Thus, the ordinary artisan would understand
from the disclosure as originally filed that “plastically bonded” requires the
conductive element to be placed in the mold during the injection molding
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process, resulting in a reservoir housing that is essentially a single integral
component with no openings or other passages through the housing which
would require subsequent sealing.

CONCLUSION OF LAW
We find that Appellants demonstrated that the Examiner erred in
finding that the phrase “plastically bonded” is not supported by the
disclosure as filed.
We thus reverse the rejection of claims 16, 27 and 28 under 35 U.S.C.
§ 112, first paragraph, as containing new matter.

ISSUES (Art Rejections)
The Examiner finds that the claims on appeal are anticipated by, or
rendered obvious by, Jones, Bremer, Untereker, and Wright, either alone, or
in combination.
Appellants contend as to independent claims 1, 3, 5, 16, 27, and 28,
that none of the references relied upon by the Examiner, either alone or in
combination, teach or suggest a reservoir and conductive element that are
“integrally formed” or “plastically bonded” and provide a moisture tight
interface between the conductive element and the reservoir housing; and
further, as to independent claims 4, 17 and 29, that a liquid tight interface is
not necessarily a water vapor tight interface.
Thus, the issues on appeal are:
Have Appellants demonstrated that the Examiner erred in finding as to
claims 1, 3, 5, 16, 27, and 28, that the references, either alone or in
combination, teach or suggest a reservoir and conductive element that are
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“integrally formed” or “plastically bonded” and provide a moisture tight
interface between the conductive element and the reservoir housing; and
Have Appellants demonstrated that the Examiner erred in finding as to
claims 4, 17 and 29, that a liquid tight interface reads on a moisture tight
interface?

FINDINGS OF FACT
FF10 The Examiner rejects claims 1, 4, 5, and 8 under 35 U.S.C. § 102(b)
as being anticipated by Jones (Ans. 5).
FF11 The Examiner interprets the “integrally formed” as a product-by-
process limitation, which is not limited to a single integral component that
has no openings or passages through the housing (id. at 11).
FF12 The Examiner finds that “Jones discloses a reservoir housing (see
figures 4D and 4E) that includes a cavity (2) with an interior and exterior
surface which is formed of a non-conductive material . . . and a monolithic
conductive element (40,47) disposed within a portion of the reservoir (52).”
(Id. at 5.)
FF13 The Examiner finds that the conductive element is integral with the
housing as it forms one unit, and that the conductive element and the
housing form a liquid and moisture tight interface, finding further that a fluid
tight seal reads on moisture tight (id.).
FF14 As to claim 4, the Examiner finds that the “conductive element has a
peripheral portion or lip (40) that extends radially outward over the outer
surface of the housing and an electrical component (42).” (Id.)
FF15 Jones relates to “covers to be placed on the human body, and around a
wound, to contain healing fluid in contact with the wound; and, in particular,
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to such covers which include electrical circuits for ion generation.” (Jones,
col. 1, ll. 5-9.)
FF16 Figures 4D and 4E of Jones are reproduced below:

Figure 4D is a pictorial view of the cover, and Figure 4E is a cross-sectional
view of a multiple junction thermoelectric assembly (Jones, col. 2, ll. 20-29).
FF17 The thermoelectric assembly is built around an anode rivet with a
broad head 47 that is mounted through a hole in the top of the fluid chamber
(id. at col. 4, ll. 7-15).
FF18 The Examiner rejects claims 1, 4, 5, 8, 27, and 28 under 35 U.S.C.
§ 103(a) as being obvious over the combination of Bremer and Jones (Ans.
5).
FF19 The Examiner finds that “Bremer discloses a connector that has a
moisture tight interface with a housing with a cavity.” (Id. at 5-6 (citing
Bremer, col. 3, ll. 45-50, and Figure 3).)
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FF20 Bremer is drawn to an electrode that “ensures effective and sustained
conductive contact, at low impedence, between the body surface and the
terminal of the electrode.” (Bremer. col. 1, ll. 42-45.)
FF21 Figure 3 of Bremer is reproduced below:

Figure 3 is a cross-sectional view of an electrode of Bremer (id. at col. 2, ll.
54-57).
FF22 According to Bremer:
As illustrated in the cross-sectional view of FIG. 3, the
terminal 34 constitutes a male snap fastener assembly
consisting of a lower washer-like disk 38 with a central,
integrally formed upwardly extending stud 40. The second
snap fastener element is a surmounting flanged conductive cap
44 formed with an upwardly projecting downwardly opening
stud receiving socket 46. To secure the terminal 34 to the roof
30 of the housing 24, the stud 40 of the lower component 38 is
inserted upwardly to extend through an opening 50 at the apex
of the roof 30 of the housing 24 and into the cooperating socket
46 of the cap 44. The two parts 38 and 44 are then forcibly
pressed or crimped together to establish a mechanical interlock
and to form a fluid-tight seal with the interposed plastic housing
24.

(Id. at col. 3, ll. 34-49.)
FF23 The Examiner notes that Bremer fails to teach a monolithic
conductive element, but finds that Jones teaches such a device (Ans. 6).
FF24 The Examiner finds that “the conductive element of Jones forms a
seal with the housing and thus would form a moisture tight seal when used
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in the device of Bremer. Combining the references would not destroy the
seal; rather, the combination would provide one seal in place of another.”
(Id. at 11.)
FF25 The Examiner rejects claims 12-14, 16, 17, 21-26, and 29 under 35
U.S.C. § 103(a) as being obvious over the combination of Bremer and Jones,
as further combined with Wright (Ans. 8).
FF26 The Examiner relies on the combination of Bremer and Jones as set
forth above, notes that the combination “fails to include the conductive
element comprising a polymer/plastic.” (Id.)
FF27 The Examiner cites Wright for teaching the use of a conductive
element that is a plastic loaded with a carbon fiber that is disposed within a
portion of a housing (id. at 8-9).
FF28 The Examiner concludes that “it would have been obvious to make
the conductive element of Bremer in view of Jones from the material
(polypropylene-carbon fiber) as disclosed by Wright” as the “references are
analogous in the art of medical electrodes for placement on a patient’s
body.” (Id. at 9.)
FF29 The Examiner rejects claim 3 under 35 U.S.C. § 103(a) as being
obvious over the combination of Untereker and Jones (Ans. 7).
FF30 The Examiner finds that Untereker “discloses a housing (10) having a
cavity (portion of housing that contains reservoir 16 and electrode 12),”
wherein a “conductive element (14) is disposed within a portion of the
housing (portion of element 14 that extends through the opening in the
housing 10 to between the housing and electrode 12; see figure).” (Id.)
FF31 The Examiner notes that Untereker fails to teach a monolithic
conductive element, but finds that Jones teaches such a device (id. at 7-8).
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FF32 The Examiner concludes that “the conductive element of Jones forms
a fluid tight seal with the housing of Jones and in the same way would form
a fluid tight seal with the housing of Untereker.” (Id. at 12.)

PRINCIPLES OF LAW
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
[T]he PTO applies to the verbiage of the proposed claims the
broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of
definitions or otherwise that may be afforded by the written
description contained in the applicant’s specification.

In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
To anticipate, every element and limitation of the claimed invention
must be found in a single prior art reference, arranged as in the claim.
Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir.
2001).
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court rejected a rigid application of a teaching-suggestion-
motivation test in the obviousness determination. The Court emphasized
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that “the [obviousness] analysis 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. Thus, an “[e]xpress suggestion to
substitute one equivalent for another need not be present to render such
substitution obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982).
Further,
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.

KSR, 550 U.S. at 417.
While the analysis under 35 U.S.C. § 103 allows flexibility in
determining whether a claimed invention would have been obvious, it still
requires showing that “there was an apparent reason to combine the known
elements in the fashion claimed by the patent at issue.” Id. at 418. “We
must still be careful not to allow hindsight reconstruction of references to
reach the claimed invention without any explanation as to how or why the
references would be combined to produce the claimed invention.”
Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir.
2008).

ANALYSIS
The independent claims on appeal are 1, 3-5, 16, 17, and 27-29.
Claims 1, 3 and 5 require that the monolithic element is “integrally formed”
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with at least a portion of the reservoir, such that a moisture tight interface is
formed between the conductive element and the reservoir housing. Claims
16, 27 and 28 require a conductive element being “plastically bonded” with
at least a portion of the reservoir housing. The Examiner interprets those
limitations as product by process limitations that do not limit the claimed
structure. We disagree with that interpretation. We interpret both
“integrally formed” and “plastically bonded,” consistent with our analysis
under the new matter rejection, as requiring the conductive element to be
placed in the mold during the injection molding process, resulting in a
reservoir housing that is essentially a single integral component with no
openings or other passages through the housing which would require
subsequent sealing, and resulting in a moisture tight interface between the
conductive element and the reservoir housing. This claim interpretation is
also consistent with Appellants’ arguments regarding both the new matter
and prior art rejections.
Appellants argue that none of the references relied upon by the
Examiner, either alone or in combination, teach or suggest “a reservoir and
conductive element that are ‘integrally formed’ and provide a moisture tight
interface between the conductive element and the reservoir housing.” (App.
Br. 11-19.)
Specifically, as to Jones, Appellants argue that Jones “requires a hole
through the housing to secure the rivet to the cover top.” (Id. at 11.)
Bremer, Appellants assert, like Jones, “teaches separate components that are
mechanically crimped together.” (Id. at 14.) Finally, as to Untereker,
Appellants assert that “Untereker (like Bremer . . .) requires a snap
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connector 14 that fits through a hole in the housing (like in Jones).” (Id. at
17.)
The Examiner does not refute Appellants characterization of the
Jones, Bremer and Untereker references, but instead argues that the features
that Appellants rely on to differentiate the claimed structure from those of
the cited references, that is, a single integral component with no openings or
other passages through the housing are not recited in the claims, and
interprets “integrally formed” and “plastically bonded” as process
limitations that do not limit the structure (Ans. 11-12). As noted above, we
disagree with the Examiner’s interpretation, and interpret “integrally
formed” and “plastically bonded” as limiting the structure as set forth in the
above claim interpretation. We thus reverse the art rejections as to claims 1,
3, 5, 16, 27, and 28, as well as the claims dependent thereon.
Claims 4, 17 and 29, and the claims dependent thereon, however,
stand on a different footing. Those claims do not contain the above
discussed limitations of “integrally formed” or “plastically bonded,” but
merely require that a conductive element is disposed within a portion of said
reservoir housing to provide a moisture tight interface.
As to the rejection of claim 4 as being anticipated by Jones,
Appellants argue that “fluid tight as disclosed in Jones does not read on
moisture tight.” (App. Br. 12.) Appellants argue that since the components
are bonded or sealed together during the injection molding process, the
device is both liquid and moisture tight (id. at 12-13).
Appellants’ arguments are not convincing, as claim 4 does not require
that the conductive element be “integrally formed” or “plastically bonded”
within the reservoir housing, but only requires that the conductive element
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be “disposed within” a portion of the reservoir housing. As found by the
Examiner, and Appellants do not dispute, Jones teaches a conductive
element disposed within a reservoir housing to provide a “fluid tight”
barrier. While Appellants argue that “fluid tight” does not necessarily mean
“moisture tight,” they have not provided any evidence to that effect, and
arguments of counsel cannot take the place of evidence in the record. In re
Scarbrough, 500 F.2d 560, 566 (CCPA 1974).
Appellants argue further that “the electrode in Jones does not extend
radially over the outer surface of the reservoir housing as required by . . .
claim 4.” (App.Br. 13.) Appellants assert that in Jones, “the rivet stem 40
extends outwards over the thermoelectric stack 42, not the outer surface of
the reservoir.” (Id.)
Here, we find that Appellants have the better argument. While the
rivet stem 40 arguably extends over the anode rivet 47, the Examiner has not
explained how it extends outwardly over the outer surface of the reservoir
housing.
As to the rejection of claim 4 over Bremer and Jones, Appellants
argue that one could not use one conductive element in the device of
Bremer, because Bremer requires two conductive parts 38 and 42 to be
crimped together to make the seal with housing 24, and thus Jones and
Bremer cannot be combined as suggested by the Examiner (App. Br. 13).
Appellants argue further that Bremer teaches a fluid tight seal, which is not
necessarily a moisture tight seal (id. at 14).
Appellants’ arguments are not convincing. The seal of Bremer is very
simple—crimping together of two parts with the housing to form a moisture
tight seal, and Appellants have not demonstrated that it would have been
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beyond the level of skill in the art to modify the device of Bremer with a
monolithic conductive element as taught by Jones. In addition, as to the
requirement for a moisture tight seal, as noted with the anticipation rejection
of claim 4 over Jones, claim 4 only requires that the conductive element be
“disposed within” a portion of the reservoir housing. As found by the
Examiner, and Appellants do not dispute, Bremer and Jones teach a
conductive element disposed within a reservoir housing to provide a “fluid
tight” barrier. While Appellants argue that “fluid tight” does not necessarily
mean “moisture tight,” they have not provided any evidence to that effect,
and arguments of counsel cannot take the place of evidence in the record.
As to the rejection of claims 17 and 29 over Bremer, Jones and
Wright, Appellants argue that Bremer, Jones and Wright teach components
that are crimped together, and thus there is no bond between the conductive
element and the housing (App. Br. 18). Appellants again further argue that a
“liquid tight interface is not necessarily a water vapor tight interface.” (Id.)
Claim 17 requires “a conductive element which is disposed within a
portion of said reservoir housing, the conductive element being made from a
polymeric material having a molded bond with said reservoir housing.”
Claim 29 has similar language. Claims 17 and 29 are thus not limited to the
conductive element being “integrally formed” or “plastically bonded” within
the reservoir housing, but only that the conductive element have a “molded
bond” with said housing. Giving “molded bond” its broadest reasonable
interpretation, we find that it reads on a crimp as the polymeric material is
“molded” when it is crimped with other materials to form the fluid tight seal.
As to Appellants’ argument that a liquid tight interface is not necessarily a
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moisture tight interface, that argument is not convincing for the reasons set
forth above.

CONCLUSIONS OF LAW
We conclude that:
Appellants have demonstrated that the Examiner erred in finding as to
claims 1, 3, 5, 16, 27, and 28, that the references, either alone or in
combination, teach or suggest a reservoir and conductive element that are
“integrally formed” or “plastically bonded” and provide a moisture tight
interface between the conductive element and the reservoir housing;
But that Appellants have not demonstrated that the Examiner erred in
finding as to claims 4, 17 and 29, that a liquid tight interface reads on a
moisture tight interface.
We thus:
Reverse the rejection of claims 1, 4, 5, and 8 under 35 U.S.C. § 102(b)
as being anticipated by Jones as to all of the claims;
Reverse the rejection of claims 1, 4, 5, 8, 27, and 28 under 35 U.S.C.
§ 103(a) as being obvious over the combination of Bremer and Jones as to
claims 1, 5, 8, 27, and 28, but affirm as to claim 4;
Reverse the rejection of claims 12-14, 16, 17, 21-26, and 29 under 35
U.S.C. § 103(a) as being obvious over the combination of Bremer and Jones,
as further combined with Wright as to claims 12-14, 16, 21-26, but affirm as
to claims 17 and 29; and
Reverse the rejection of claim 3 under 35 U.S.C. § 103(a) as being
obvious over the combination of Untereker and Jones.

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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-IN-PART

cdc

Diehl Servilla LLC
77 Brant Avenue, Suite 210
Clark NJ 07066

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