Ex Parte Pensel

Board of Patent Appeals and Interferences

Sep 15, 2008

10374365 (B.P.A.I. Sep. 15, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte JUERGEN PENSEL
____________

Appeal 2008-3679
Application 10/374,365
Technology Center 1600
____________

Decided: September 15, 2008
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 22-29 and 32-43.
Pending claims 30 and 31 have been withdrawn from consideration (App.
Br. 2). We have jurisdiction under 35 U.S.C. § 6(b).

Appeal 2008-3679
Application 10/374,365

INTRODUCTION
The claims are directed to a medical device. Claim 22 is illustrative:
22. A medical device comprising:
a surgical microscope defining a surface exposed to the surrounding
environment, said surface being passively germiphobal by having a plurality
of elevations or indentations spaced from one another to achieve a lotus
blossom effect.

The Examiner relies on the following prior art references to show
unpatentability:
Yan et al. US 4,960,425 Oct. 2, 1990
Davidson US 5,649,951 Jul. 22, 1997
Burrell et al. (Burrell I) US 5,681,575 Oct. 28, 1997

Burrell et al. (Burrell II) WO 92/11043 Jul. 9, 1992

The rejections as presented by the Examiner are as follows:
1. Claims 22-24, 27-29, 32, and 36-43 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Davidson and Yan.
2. Claims 22-29 and 32-43 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Burrell I and Burrell II.
We reverse.

CLAIM INTERPRETATION
Claim 22 is drawn to a medical device. The claimed device comprises
a surgical microscope. The surgical microscope defines a surface that is
exposed to the surrounding environment. “Explicitly not comprised in the
invention are non-optical instruments for invasive interventions” (Spec. 1: 9-
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10). Claim 22 requires that the surface defined by the surgical microscope is
passively germiphobal (e.g., germ-repellent (see App. Br. 2)). The surface is
made passively germiphobal by having a plurality of elevations or
indentations spaced from one another to achieve, what Appellant refers to as,
a “lotus blossom effect” (Claim 22).
As to the “lotus blossom effect” Appellant’s Specification explains
that:
In a special surface formation according to the invention-
-primarily also for ceramic surfaces--the following principle is
employed: The surface is physically (e.g. chemically and/or
micro-mechanically) structured such that undesirable
substances cannot adhere. A possible configuration thus
provides the intentional arrangement of elevations with specific
geometric dimensions that offer substances (e.g. liquids) no
support on the surface due to their surface tension. The
substances therefore cannot exert any adhesive forces on the
surface.
Comparable effects are known in nature, e.g. in the
natural surface formation of lotus leaves (surface structure) . . .
on which water beads up without dampening the leaf when
picking up any kind of adjacent dirt particles.
. . .
A surface with the following geometric structure is
indicated as an example of such a surface structure (in some
cases it does not have to be in a mathematically exact
configuration):
Sin(x) x Cos(y).
The resulting surface has a regular mound structure, the
peaks of which preferably have the following interval: 1-100
µm, in particular 3-60 µm.
Alternatively, the elevations can also have a cubic or
conical structure.
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The invention nevertheless also encompasses mixed
forms that one skilled in the art can determine in routine
experiments.

(Spec. 5: 24 - 6: 22.)
In addition, Appellant’s Specification discloses that “[t]he
effectiveness of such surfaces formed according to the invention can be
strengthened by combination with other measures according to the
invention, such as a germicidal dressing (e.g., metal or metallic salt
coating)” (Spec. 6: 24-26). According to Appellant, germicidal substances
“are all of those substances that have been traditionally used or will be used
in the future to kill germs or to disinfect” (Spec. 7: 5-7).
Therefore, the surface defined by the surgical microscope must have a
plurality of elevations or indentations that are spaced from one another such
that substances (e.g., germs) cannot exert any adhesive forces on the surface
(e.g., the lotus blossom effect). Thus, while the surface defined by the
surgical microscope may comprise germicidal substances, the surface itself
is passively germiphobal.
Claims 23-29 and 32-43 depend directly or indirectly from claim 22.

FINDINGS OF FACT (FF)
1. Davidson teaches “stents of enhanced biocompatibility” (Davidson, col.
1, l. 16).
2. Yan teaches a surgical prosthesis for use in “mammary and other
implants” (Yan, Abstract).
3. Burrell I teaches anti-microbial coatings for medical devices (Burrell I,
Abstract; Ans. 5).
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4. Burrell I teaches that the term “medical devices” extends to products
such as medical devices used by physicians and surgeons; “appliances
ranging from orthopaedic pins, plates and implants”; “wound
dressings”; “urinary catheters”; “consumer healthcare and personal
hygiene products”; and “biomedical/biotechnical laboratory equipment”
(Burrell I, col. 1, ll. 23-28).
5. Burrell I teaches that the coatings on the medical devices “are formed
by depositing a biocombatible metal by vapor deposition techniques to
produce atomic disorder in the coating such that a sustained release of
metal ions sufficient to produce an anti-microbial effect is achieved”
(Burrell I, Abstract).
6. Burrell I teaches that “[a]tomic disorder leads to irregularities in surface
topography and inhomogenieties in the structure on a nanometer scale”
(Burrell I, col. 3, ll. 56-57).
7. Burrell I teaches that “[t]he term ‘atomic disorder’ . . . includes high
concentrations of: point defects in a crystal lattice, vacancies, line
defects such as dislocations, interstitial atoms, amorphous regions, grain
and sub grain boundaries and the like relative to its normal ordered
crystalline state” (Burrell I, col. 3, ll. 51-55).
8. Burrell I teaches that “the anti-microbial effects of metallic ions such as
Ag, Au, Pt, Pd, Ir (i.e., the nobel metals), Cu, Sn, Sb, Bi and Zn are
known” (Burrell I, col. 1, ll. 29-31) and that “the metal ions exhibiting
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the greatest anti-microbial effect are the noble metals, such as Ag, Au,
Pt and Pd” (Burrell I, col. 2, ll. 51-53).1
9. Burrell I teaches that “anti-microbial composite materials are also
preferably prepared by co- or sequentially depositing an anti-microbial
metal with one or more inert biocompatible metals selected from Ta, Ti,
Nb, Zn, V, Hf, Mo, Si, and Al” (Burrell I, col. 6, ll. 59-62).
10. Burrell I teaches that anti-microbial powders “may be incorporated into
a polymeric, ceramic or metallic matrix to be used as a material for
medical devices or coatings therefore” (Burrell I, col. 10, ll. 40-42).
Burrell I teaches that “[t]he anti-microbial coatings so produced were
found to provide sustained release of anti-microbial metal species into
solution so as to produce an anti-microbial effect” (Burrell I, col. 3, ll.
36-39).
11. Burrell I teaches that the medical devices formed from, incorporating,
carrying or coated with the anti-microbial material exhibit atomic
disorder that “results in enhanced solubility (release) of the metal as
ions, atoms, molecules or clusters into an appropriate solvent” (Burrell
I, col. 7, ll. 17-20).
12. Burrell I teaches that “[t]he medical devices formed from,
incorporating, carrying or coated with the anti-microbial material of this
invention generally come into contact with an alcohol or water based
electrolyte including a body fluid . . . or body tissue . . . for any period

1 Burrell I discloses that “the terms ‘metal’ or ‘metals’ as used herein are
meant to include one or more metals whether in the form of substantially
pure metals, alloys or compounds such as oxides, nitrides, borides,
sulphides, halides or hydrides” (Burrell I, col. 4, ll. 1-4).
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of time such that microorganism growth on the device surface is
possible” (Burrell I, col. 7, ll. 23-29).
13. Burrell II teaches “actively antimicrobial surfaces” (Burrell II, 1: 4) for
use as “surgical dressings, bandages and the like, . . . microbial
treatments, such as water purification and killing of microorganisms in
various fluids such as blood” (Burrell II, 16: 4-9).
14. Burrell II teaches that “[c]atheters, implants, bandages, diapers, diaper
liners, dressings, and the like can be readily coated with thin films of
active elements which, when in contact with body fluids, release
substances and ions which stop the growth of or kill various types of
microorganisms” (Burrell II, 4: 29-33).
15. Burrell II teaches that “[t]he microlayers, as developed on the substrate,
can have a thickness of a few molecules and hence be in the range of 5
to 500 nanometers in thickness. Preferred, however, is a total film
thickness of about 1 u consisting, say, of ten layers each of about 1000
A thick” (Burrell II, 10: 12-18).
16. Burrell II teaches that
[b]y building on the substrate a plurality of layers of a selected
active element or metal, in combination with layers of an
element metal or alloy more noble in the electrochemical scale
than the selective active element, galvanic action is produced in
the presence of biological fluids causing release of ions of the
active element. For example, silver may be used as the element
for building a first layer and then the nobler gold or platinum
may be used for the adjacent layer, etc.

(Burrell II, 8:8-15.)

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17. According to Burrell II, “[a] textured or open film composition can be
created” (Burrell II, 10: 27); where, for example, peaks and valleys “are
formed in the surface and expose layers throughout the film” (Burrell,
13: 28-29). For clarity, we reproduce Burrell II’s Figure 1b below:

“Figure 1b is an enlarged and enhanced section through the layers of
Figure 1a showing the peaks and valleys of an ion etched surface”
(Burrell II, 12: 32-34).
18. Burrell II teaches that “[t]he significance of surface texturing of the
element microlaminates in producing enhanced release of metal ions,
and hence antimicrobial efficacy” (Burrell II, 16: 14-16).

DISCUSSION
1. Claims 22-24, 27-29, 32, and 36-43 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Davidson and Yan.
Davidson teaches “stents of enhanced biocompatibility” (FF 1). The
Examiner finds that “Davidson teaches a stent comprising a coating of
zirconium oxide (ceramic) . . . to improve friction and wear characteristics”
(Ans. 3-4).
Yan teaches a surgical prosthesis for use in “mammary and other
implants” (FF 2). The Examiner finds that “Yan teaches a medical device
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comprising a coated surface having minute indentations . . . [to] minimize
friction irritation” (Ans. 4).
Based on these facts the Examiner concludes that it would have been
obvious to one of ordinary skill in the art at the time the invention was made
to utilize Yan’s surface texture on Davidson’s stent (id.). According to the
Examiner since “Davidson teaches a stent that is used to prop open vessels
including blood vessels” “the combination of Davidson and Yan . . . teaches
a surgical microscope having a surface as set forth in claim 22” (Ans. 6).
We are not persuaded.
The Examiner has failed to provide an evidentiary foundation to
support the assertion that a person of ordinary skill in this art would consider
a surgical microscope to read on Davidson’s stent or Yan’s prosthesis usable
for mammary or other implants (Cf. App. Br. 5 (“The combination of
references fails to disclose a surgical microscope having a surface as set
forth in claim 22”)). Stated differently, the Examiner has not identified, and
we do not find, a teaching of a surgical microscope in either Davidson or
Yan. Accordingly, the combination of references fails to teach a device that
comprises a surgical microscope as is required by the claims before us on
appeal.
For the foregoing reasons we reverse the rejection of claims 22-24,
27-29, 32, and 36-43 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Davidson and Yan.

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2. Claims 22-29 and 32-43 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Burrell I and Burrell II.
Appellant does not dispute and therefore concedes that the medical
devices of Burrell I (FF 3 and 4) read on a surgical microscope.2
As discussed above, while the surface defined by the claimed surgical
microscope is passively germiphobal, it may comprise germicidal
substances. Stated differently, Appellant’s claims do not exclude the
presence of active anti-microbial agents as part of the surgical microscope’s
surface structure. Therefore, while Appellant asserts that “Burrell I
describes actively anti-microbial coatings formed by vapor deposition
techniques producing atomic disorder in the coatings such that a sustained
release of metal ions is achieved” (App. Br. 7), we note that Burrell I also
discloses that the active anti-microbial agent may be co- or sequentially
deposited with an inert (e.g., non-biologically active) biocompatible metal
(FF 9) or “incorporated into a polymeric, ceramic or metallic matrix to be
used as a material for medical devices or coatings therefore” (FF 10).
Therefore, the issue is not whether Burrell I’s surface comprises
active anti-microbial agents (see FF 8), instead the issue is whether Burrell
I’s surface is configured in a manner that would be passively germiphobal.
Accordingly, we are not satisfied with the Examiner’s conclusion that
simply because Burrell I may use similar materials as Appellant, “the
coating composition of Burrell I is passively germiphobal as claimed” (Ans.
8 (emphasis added)).

2 Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii) (“Any
arguments or authorities not included in the brief or a reply brief ... will be
refused consideration by the Board, unless good cause is shown.”).
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The coatings on Burrell I’s medical devices are formed by a process
that produces atomic disorder, which leads to irregularities in surface
topography and inhomogenieties in the structure on a nanometer scale (FF 5-
7). The defining question, therefore, is whether Burrell I’s surface structure
is passively germiphobal, e.g., “[t]he surface is physically (e.g. chemically
and/or micro-mechanically) structured such that undesirable substances
cannot adhere” (Spec. 5: 25-26). Burrell I teaches that it is not.
Burrell I expressly teaches that it is possible for microorganisms to
grow on the surface of the devices (FF 12). Further, as the Examiner
recognizes, Burrell I does not teach a passively germiphobal surface having
a plurality of elevations or indentations spaced from one another to achieve a
lotus blossom effect, such that substances (e.g., germs) cannot exert any
adhesive forces on the surface as it is defined in Appellant’s Specification
(see Ans. 5 (“Burrell I does not teach the claimed surface having
indentations or elevations”)).
To the contrary, Burrell I teaches that the structure of the medical
device’s surface is intended to enhance the release of “metal as ions, atoms,
molecules or clusters into an appropriate solvent” (FF 11).
Nevertheless, to make up for the deficiency in Burrell I, the Examiner
relies on Burrell II for the sole purpose of teaching of a coating surface
having “valleys and peaks” (Ans. 5 and 9). The Examiner asserts that
“similar the [sic] Burrell I, Burrell II teaches a coating for medical devices
that is germiphobal” (Ans. 9). However, as discussed above, Burrell I
expressly teaches that the coating for medical devices is not passively
germiphobal.
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Thus, the defining question is whether Burrell II’s surface structure is
passively germiphobal and, if so, would it have been prima facie obvious to
a person of ordinary skill in the art at the time the invention was made to
modify Burrell I’s surface coating with the surface coating taught by Burrell
II. In this regard, the Examiner asserts that since the valleys and peaks on
the coating surface of Burrell II resemble the sinusoidal and cosinusoidal
structure contemplated by Appellant “the lotus blossom effect is necessitated
by similar indentations” (Ans. 10). We are not persuaded.
The Examiner recognizes that the coatings of Burrell I and Burrell II
are similar (Ans. 9). Contrary to the claimed invention, Burrell I expressly
teaches that it is possible for microorganisms to grow on the surface of the
devices (FF 12). Rather than provide a passively germiphobal surface,
Burrell I teaches that the anti-microbial coatings provide sustained release of
anti-microbial metal species into solution so as to produce an anti-microbial
effect (FF 10). Similarly, Burrell II teaches that the coating will stop the
growth of or kill various types of microorganisms through the enhanced
release of metal ions from the coating (FF 14 and 18). However, neither
Burrell reference expressly teaches a surface structure that is physically
structured such that undesirable substances cannot adhere, e.g., the lotus
blossom effect.
As to the similarity between Appellant’s claimed invention and the
peaks and valleys of Burrell II’s coating, we find that the Examiner has not
provided a sufficient evidentiary basis to conclude that Burrell II’s coating
would be passively germiphobal as required by Appellant’s claimed
invention. To the extent that the Examiner is somehow relying on an
inherency theory, we note that, “[i]nherency, however, may not be
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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
Oelrich, 666 F.2d 578, 581 (CCPA 1981)
The initial burden of presenting a prima facie case of obviousness
rests on the Examiner. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
On this record, we are constrained to reach the conclusion that the Examiner
has failed to provide the evidence necessary to support a prima facie case of
obviousness.
For the foregoing reasons, we reverse the rejection of claims 22-29
and 32-43 under 35 U.S.C. § 103(a) as unpatentable over the combination of
Burrell I and Burrell II.

CONCLUSION
In summary, we reverse the rejections of record.

REVERSED

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Hodgson Russ LLP
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