Ex Parte Krulevitch et al

Board of Patent Appeals and Interferences

Apr 7, 2010

10115676 (B.P.A.I. Apr. 7, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte PETER KRULEVITCH, DENNIS L. POLLA, MARIAM N.
MAGHRIBI, JULIE HAMILTON, and MARK S. HUMAYUN
____________

Appeal 2009-006364
Application 10/115,676
Technology Center 3700
____________

Decided: April 8, 2010
____________

Before JOHN C. KERINS, MICHAEL W. O’NEILL and
STEFAN STAICOVICI, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON APPEAL
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STATEMENT OF THE CASE
Peter Krulevitch et al. (Appellants) appeal under 35 U.S.C. § 134
(2006) from the Examiner’s decision rejecting claims 1, 3-5, 14-18, 24, 25,
31, and 57. Claims 32-56 have been withdrawn by the Examiner and claims
2, 6-13, 19-23, 26-30, and 58-61 have been canceled. We have jurisdiction
over this appeal under 35 U.S.C. § 6 (2006).

THE INVENTION
Appellants’ invention relates to an implantable electrode array system
10 for artificial vision including a compliant substrate material 11 having
embedded electrodes 12, conductive leads 16, and an electronic chip 18.
Spec. 11, para. [0012]; Spec. 18, para. [0019]; and figs. 6 and 9.
Claim 1 is representative of the claimed invention and reads as
follows:
1. An electrode array apparatus adapted to contact tissue,
the electrode array apparatus consisting of:
an electrode array body composed of silicone,
a multiplicity of individual electrodes adapted to contact
the tissue, wherein said electrodes are embedded in said
electrode array body, and
conductive leads connected to said electrodes, wherein
said conductive leads are embedded in said electrode array
body.

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THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
Child US 6,399,155 B2 Jun. 4, 2002
Greenberg US 2002/0111658 A1 Aug. 15, 2002

The following rejections are before us for review:
The Examiner rejected claims 1, 3-5, 14-18, 24, 25, 31, and 57 under
35 U.S.C. § 112, first paragraph, for failing to comply with the written
description requirement.
The Examiner rejected claims 1, 3, 4, 14, 15, 17, 18, 24, 25, 31, and
57 under 35 U.S.C. § 102(e) as anticipated by Greenberg.
The Examiner rejected claims 5, 10, 17, 24, and 31 under 35 U.S.C.
§ 103(a) as unpatentable over Greenberg.
The Examiner rejected claim 16 under 35 U.S.C. § 103(a) as
unpatentable over Greenberg and Child.

THE ISSUES
Appellants argue that although the claims utilize the transitional
phrase “consisting of,” the original specification satisfies the written
description requirement because it “describe[s] the electrode array apparatus
of the claimed invention with the specific elements of the claims.” Reply
Br. 2. See also App. Br. 11. Specifically, Appellants point to Figure 6 of
the Drawings as showing “electrodes 12a and conductive leads 16 embedded
in a PDMS (a form of silicone rubber) substrate 11.” App. Br. 12. In
response, the Examiner takes the position that “the originally-filed
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disclosure does not provide support for the exclusion of other elements from
the [claimed] apparatus.” Ans. 7.
As such, the first issue presented for our consideration in the instant
appeal is whether the originally filed application supports the exclusion of
other elements from the claimed electrode array apparatus such that
Appellants’ use of the transitional phrase “consisting of” in the claims has
adequate written descriptive support.
Appellants further argue that because the claims utilize the transitional
phrase “consisting of” Greenberg does not anticipate Appellants’ claimed
invention because the electrode array of Greenberg includes additional
elements, namely, strain relief tab 12, reinforcing ring 14, and grasping
handle 46. App. Br. 15. See also Reply Br. 3-4. The Examiner responds
that “[t]he strain relief tab (12) and grasping handle (46) are merely
geometric features of the claimed ‘electrode array body,’ and [do] not
[constitute] additional elements.” Ans. 5.
Hence, the second issue presented for our consideration in the instant
appeal is whether the teachings of Greenberg anticipate Appellants’ claimed
invention. The issue turns on whether strain relief tab 12, reinforcing ring
14, and grasping handle 46 of Greenberg constitute separate (additional)
elements from the electrode array body 4.
Lastly, Appellants argue that the Examiner has not provided an
adequate reason why a person of ordinary skill in the art would have used
either polydimethylsiloxane (PDMS) or liquid silicone rubber to make
Greenberg’s electrode array body 4. App. Br. 21and 25. The Examiner
responds that choosing PDMS “would have been an obvious matter of
design choice to a person of ordinary skill in the art…because applicant has
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not disclosed that PDMS provides an advantage, is used for a particular
purpose, or solves a stated problem.” Ans. 6. The Examiner further asserts
that because Child teaches that liquid silicone rubber “is an equivalent
polydimethylsiloxane group elastomer with similar properties to silicone…
substituting one functionally equivalent elastomer for another would have
amounted to an obvious design choice to those of ordinary skill in the art at
the time of the invention.” Ans. 6-7.
Accordingly, the third issue presented for our consideration in the
instant appeal is whether the Examiner has provided an adequate reason why
a person of ordinary skill in the art would have used either
polydimethylsiloxane (PDMS) or liquid silicone rubber to make Greenberg’s
electrode array body.

SUMMARY OF DECISION
We AFFIRM.

OPINION
Issue (1)
Each of claims 1, 3-5, 14-18, 24, 25, 31, and 57 uses in the preamble
the transitional phrase “consisting of.” The transitional phrase “consisting
of” excludes any element, step, or ingredient not specified in the claim. In
re Gray, 53 F.2d 520, 521 (CCPA 1931).1 In this case, each of claims 1, 3-
5, 14-18, 24, 25, 31, and 57 requires a silicone body embedded with

1 See also Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948)
(“consisting of” defined as “closing the claim to the inclusion of materials
other than those recited except for impurities ordinarily associated
therewith.”).

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electrodes and conductive leads connected to the electrodes. See App. Br.,
Claims App’x. 1, 18, 25, and 57.
To satisfy the written description requirement, the disclosure must
convey with reasonable clarity to skilled artisans that the Appellants were in
possession of the claimed invention as of the filing date. Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). “The invention is, for
purposes of the ‘written description’ inquiry, whatever is now claimed.” Id.
at 1564. In this case, Appellants’ Specification describes an electrode array
10 including various elements in addition to the claimed elements. For
example, in Figure 6 of Appellants’ Drawings, which Appellants have relied
on as providing an adequate written description, the electrode array includes
silicone body 11 (PDMS), electrodes 12a, conductive leads 16, and an
additional handle wafer 14. In Figures 7-10, an additional second silicone
layer 17 (PDMS) is shown. Lastly, the embodiments shown in Figures 9
and 10 include, respectively, an additional electronic chip 18, and
additional ribbon cable 24 and connector 25. Hence, we could not find any
description in Appellants’ Specification, and Appellants have not pointed to
any portion of the Specification, that would convey with reasonable clarity
to a person of ordinary skill in the art that Appellants were in possession of
an invention claimed as an electrode array consisting of a silicone body
embedded with electrodes and conductive leads connected to the electrodes.
All of the described embodiments include elements in addition to the
claimed elements.
In conclusion, the rejection of claims 1, 3-5, 14-18, 24, 25, 31, and 57
under 35 U.S.C. § 112, first paragraph, for failing to comply with the written
description requirement is sustained.
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Issue (2)
It is our finding that Greenberg teaches a silicone electrode array body
4 including a plurality of electrodes 6 that are attached to conductors 8.
Greenberg, para. [0043] and fig. 1. Electrode array body 4 is made of
silicone having a hardness of about 50 or less on the Shore A scale.
Greenberg, para. [0044]. Strain relief internal tab 12 is defined by a strain
relief slot 13 that passes through the array body 4. Greenberg, para. [0045].
Reinforcing ring 14 is made from a higher toughness silicone than the
remainder of the electrode array body 4. Id. Lastly, grasping handle 46 is
formed on the surface of array body 4 and is made of silicone having a
hardness of about 50 on the Shore A scale. Greenberg, para. [0047] and fig.
1. As such, because strain relief tab 12 constitutes merely a slot that passes
through array body 4 and reinforcing ring 14 and grasping handle 46 are
made from silicone and constitute parts of the array body 4 of Greenberg, we
agree with the Examiner that they all represent mere “geometric features” of
Greenberg’s electrode array body 4. See Ans. 5. We believe that to interpret
strain relief tab 12, reinforcing ring 14, and grasping handle 46 as separate
elements from the array body, as Appellants argue, would be an
unreasonably narrow reading or interpretation of the Greenberg disclosure.
Accordingly, the rejection of claim 1 is sustained.
Regarding claims 3, 4, 14, 15, 18, 25, and 57, we find that Greenberg
specifically teaches that electrode array body 4 is made of a soft material,
namely, a silicone having a hardness of about 50 or less on the Shore A
scale. Greenberg, para. [0044]. Greenberg further teaches that electrode
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array body 4 conforms to the retina of a patient’s eye. Greenberg, para.
[0050] and fig. 4. Hence, we find that a person of ordinary skill in the art
would have readily appreciated that a silicone material having a hardness of
about 50 or less on the Shore A scale that is capable of conforming to the
retina of a patient’s eye when implanted is flexible and stretchable.
Accordingly, the rejection of claims 3, 4, 14, 15, 18, 25, and 57 under 35
U.S.C. § 102(e) as anticipated by Greenberg is likewise sustained.
With respect to claims 17, 24, and 31, we could not find any portion
in Greenberg, and the Examiner has not pointed to any portion in Greenberg,
which teaches that the silicone material of Greenberg’s array body 4 is
polydimethylsiloxane. "A claim is anticipated only if each and every
element as set forth in the claim is found, either expressly or inherently
described, in a single prior art reference." Verdegaal Bros, Inc.. v. Union
Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987). Since Greenberg does
not teach all the elements of claims 17, 24, and 31, the rejection of claims
17, 24, and 31 under 35 U.S.C. § 102(e) as anticipated by Greenberg cannot
be sustained.

Issue (3)
With regard to the selection of polydimethylsiloxane (PDMS), as per
claims 5, 10, 17, 24, and 31, and liquid silicone rubber, as per claim 16, the
Examiner takes the position that the modification of Greenberg “would be an
obvious matter of design choice.” Ans. 8. We note that the jurisprudence
when used in this manner amounts to a per se rule of unpatentability.
The use of per se rules, while undoubtedly
less laborious than a searching comparison of the
claimed invention--including all its limitations--
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with the teachings of the prior art, flouts section
103 and the fundamental case law applying it. Per
se rules that eliminate the need for fact-specific
analysis of claims and prior art may be
administratively convenient for PTO Examiners
and the Board. Indeed, they have been sanctioned
by the Board as well. But reliance on per se rules
of obviousness is legally incorrect and must cease.
Any such administrative convenience is simply
inconsistent with section 103, which, according to
[Graham v. John Deere Co., 383 U.S. 1, 17-18
(1966)] and its progeny, entitles an applicant to
issuance of an otherwise proper patent unless the
PTO establishes that the invention as claimed in
the application is obvious over cited prior art,
based on the specific comparison of that prior art
with claim limitations. We once again hold today
that our precedents do not establish any rules of
obviousness, just as those precedents themselves
expressly declined to create such rules.
In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995).
Per se rules used in this manner short circuit the Graham inquiry.
These rejections, instead of being based on reasoning with rational
underpinnings, are based on this per se rule. Rejections based on 35 U.S.C.
§ 103 must rest on a factual basis. In making such a rejection, the Examiner
has the initial duty of supplying the requisite factual basis and may not,
because of doubts that the invention is patentable, resort to speculation,
unfounded assumptions or hindsight reconstruction to supply deficiencies in
the factual basis. In re Warner, 379 F.2d 1011, 1017 (CCPA 1967). In this
case, the Examiner has not provided any factual evidence to show why a
person of ordinary skill in the art would have chosen, from a variety of
silicone rubbers, either polydimethylsiloxane or liquid silicone rubber to
make Greenberg’s electrode array body. The Examiner’s statement that
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“PDMS is a very common form of soft silicone used in medical implants”
(see Ans. 6) is not supported in the record by underlying factual evidence,
and thus can not properly serve as a basis for concluding that it would have
been obvious to a person of ordinary skill in the art to specifically use
PDMS instead of other types of medical materials to make Greenberg’s
implantable electrode array body.
Lastly, with respect to the rejection of claim 16 over the combined
teachings of Greenberg and Child, although polydimethylsiloxane and liquid
silicone rubber may have equivalent gas permeability characteristics, as
taught by Child (see Child, col. 4, ll. 38-53), the Examiner has not provided
any factual evidence to show why a person of ordinary skill in the art would
have considered the liquid silicone rubber of Child’s airbag coating to make
Greenberg’s electrode array body. The end uses of Child’s liquid silicone
rubber airbag coating and Greenberg’s silicone electrode array are quite
different. Specifically, the silicone electrode array of Greenberg contacts the
retina of a patient’s eye (Greenberg, para. [0044]), whereas the
polydimethylsiloxane and liquid silicone rubber of Child reduces the gas
permeability of an air bag when it is inflated. The Examiner has further not
established that persons of ordinary skill in the art would consider gas
permeability characteristics as a criterion in selecting an appropriate material
for the electrode array disclosed in Greenberg.
In conclusion, for the foregoing reasons, the rejection of claims 5, 10,
17, 24, and 31 as unpatentable over Greenberg and the rejection of claim 16
as unpatentable over Greenberg and Child cannot be sustained.

CONCLUSIONS
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1. The originally filed application does not support the exclusion of other
elements from the claimed electrode array apparatus such that
Appellants’ use of the transitional phrase “consisting of” in the claims
has adequate written descriptive support.
2. Strain relief tab 12, reinforcing ring 14, and grasping handle 46 of
Greenberg do not constitute separate (additional) elements from the
electrode array body.
3. The Examiner has not provided an adequate reason why a person of
ordinary skill in the art would have used either polydimethylsiloxane
or liquid silicone rubber to make Greenberg’s electrode array body.

DECISION
The Examiner’s decision to reject claims 1, 3-5, 14-18, 24, 25, 31, and
57 under 35 U.S.C. § 112, first paragraph, for failing to comply with the
written description requirement, is affirmed.
The Examiner’s decision to reject claims 1, 3, 4, 14, 15, 18, 25, and
57 under 35 U.S.C. § 102(e) as anticipated by Greenberg is affirmed.
The Examiner’s decision to reject claims 17, 24, and 31 under 35
U.S.C. § 102(e) as anticipated by Greenberg is reversed.
The Examiner’s decision to reject claims 5, 10, 17, 24, and 31 under
35 U.S.C. § 103(a) as unpatentable over Greenberg is reversed.
The Examiner’s decision to reject claim 16 under 35 U.S.C. § 103(a)
as unpatentable over Greenberg and Child is reversed.
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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). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2007).

AFFIRMED

mls

EDDIE SCOTT
LAWRENCE LIVERMORE NATIONAL LABORATORY
P.O. BOX 808, L-703
LIVERMORE, CA 94551