Ex Parte Anderson

Patent Trial and Appeal Board

Dec 17, 2013

11868833 (P.T.A.B. Dec. 17, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte ROBERT S. ANDERSON
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Appeal 2012-002145
Application 11/868,833
Technology Center 3700
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Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims 1-8, 14-19, and
25-45 (App. Br. 3). Examiner entered rejections under 35 U.S.C. § 103(a).
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

1 The Real Party in Interest is Aesthera Corporation of Pleasanton,
California, which has been acquired by Solta Medical, Inc. (App. Br. 3.)
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STATEMENT OF THE CASE
The claims are directed to a medical device and system for treating a
portion of skin. Claims 1, 2, 3, 14, and 18 are representative and are
reproduced in the Claims Appendix of Appellant’s Brief.
Claims 1, 2, 4-8, 14, 18, 19, and 25-45 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Morris.2
Claims 3 and 15-17 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Morris and Utely.3
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Morris’ Figures 1 and 13B are reproduced below:

“FIG. 1 is a lateral view illustrating the placement of a surface treatment
apparatus to treat a tissue mass at or beneath a tissue surface” (Morris 2:
¶ [0014]; Ans. 11-12). Fig. 13B is a “lateral view[] illustrating use of a
vacuum source coupled to porous tissue contacting surface” 14p (id. at
¶ [0026]; id. at 5: ¶ [0094]; Ans. 11-12).

2 Morris et al., US 2009/0076497 A1, published March 19, 2009.
3 Utely et al., US 6,277,116 B1, issued August 21, 2001.
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FF 2. Morris suggests a “surface treatment apparatus 10 to superficially
treat a tumor mass 5" in a target tissue site 5' at or beneath the surface 5s of
tissue 5 by delivering energy to produce an ablation volume 5av” (Morris 4:
¶ [0081]).
FF 3. Morris’ “apparatus 10 includes a housing 12 that has [an outer
housing surface] . . . and an interior space 12i. . . . [H]ousing 12 includes a
tissue contacting [conformable] surface 14 . . . [and] one or more energy
delivery devices [(electrodes)] 18” (id.; id. at 5 ¶ [0094]; see generally Ans.
11-12).
FF 4. The tissue contacting conformable surface 14 of Morris’ device can
“be configured to deliver a vacuum to between tissue contacting surface 14s
and tissue surface 5s . . . by coupling portion 14p and apparatus 10 to a
vacuum source 30v” (id. at 6 ¶ [0097]; Ans. 11-12).
FF 5. Morris’ device “includes a switching device coupled to . . . at least
one electrode, a power supply coupled to the at least one electrode . . . [and]
[i]mpedance measurement circuitry . . . coupled to . . . at least one electrode”
(id. at 1: ¶ [0009]; Ans. 12).
FF 6. The electrodes of Morris’ device “can be operated in a monopolar
mode, a bipolar mode, or a combination of both and can be switchable
between the two” (id. at 13: ¶ [0154]; see generally Ans. 16-18).
FF 7. Morris suggests that “switching between monopolar to bipolar
modes can be achieved by the use of switching circuitry . . . coupled to one
or more electrodes 18” (id. at 14: ¶ [0161]; see generally Ans. 16-18; id. at
16 (“Morris uses an impedance test to determine whether or not to use a
monopolar or bipolar mode during irradiation”)).
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FF 8. Morris suggests that
Switching to bipolar mode . . . serves to keep RF induced
heating closer to tissue surface 5s thus preventing the unwanted
heating of deeper tissue containing healthy tissue and/or
thermally sensitive structures. Thus in use, embodiments
having the ability to have feedback control to switch between
monopolar and bipolar modes present the advantage of more
refined and faster control over the depth of tissue heating to
prevent thermal injury of underlying healthy/sensitive tissue
without having to reposition the electrodes.
(Morris 14: ¶ [0161]; see generally Ans. 16-18.)
FF 9. Morris suggests that the device measures, inter alia, impedance
values and when measured impedance values exceed a predetermined value
“a warning can be given on user interface and display . . . and additionally,
the delivery of RF energy can be reduced, modified or interrupted” (id. at
18: ¶ [0190]; Ans. 17).
FF 10. Examiner finds that “Morris teaches that the needles are at least
partially recessed in the main chamber at all times” (Ans. 13).
FF 11. Morris’ Figure 21 is reproduced below:

“FIG. 21 is a lateral view illustrating an embodiment of an advancement
member comprising one or more pushable advancement members with
coupled electrodes” (Morris 2: ¶ [0033]).
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FF 12. Morris suggests that “[p]ushable member 19 has [a] proximal and a
distal portion 19p and 19d[, wherein] . . . [a]t least a portion of distal portion
19d comprise[s] electrode 18” (Morris 7: ¶ [0107]).
FF 13. Examiner finds that Appellant “does NOT define ‘distal portion’ in
the context of each electrode. Therefore, Examiner interprets ‘distal portion’
to be from the distal piercing tip to the middle of the electrode” (Ans. 18).
FF 14. Examiner finds that Morris fails to suggest “that the controller is
coupled to a return plate,” “spacers,” or “that the distal ends of the needles
are located proximally behind a distal surface of the spacer” and relies on
Utely to make up for these deficiencies in Morris (Ans. 14-15).
ANALYSIS
The rejection over Morris alone:
Based on Morris, Examiner concludes that, at the time Appellant’s
invention was made, it would have been prima facie “obvious to use
impedance to control energy through the needle electrodes, because high
impedance levels can cause damage to the tissue” (Ans. 12). In this regard,
Examiner reasons that
Although Morris does NOT discuss supplying the electrodes
with energy upon a predetermined percentage of them passing
the impedance test, it would have been obvious to make sure a
pre-determined number of electrodes passed the impedance
tests, because doing so would ensure that the tissue wasn’t
damaged and that the tissue still received a meaningful
treatment.
(Ans. 12; see also id. at 17.) Appellant agrees that Morris’ device can be
modified as suggested by Examiner (Reply Br. 7 (“Applicant does not argue
that Morris’[] device cannot be modified as suggested”)). In this regard,
Morris suggests that the device measures, inter alia, impedance values and
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when measured impedance values exceed a predetermined value “the
delivery of RF energy can be reduced, modified or interrupted” (FF 9).

Claim 1:
We recognize, but are not persuaded by Appellant’s contention that
Examiner’s modification of Morris would render Morris’ device
“unsatisfactory for one of its stated purpose[s, i.e.,] to ‘achieve a particular
pattern to precisely treat the tumor while avoiding adjacent critical
anatomical structures’ . . . because such a modification would cause the
resulting ablation volume to deviate from an intended target geometry
resulting in an imprecise treatment” (Reply Br. 6 (emphasis added); App. Br.
10-11). Morris’ device “can be operated in a monopolar mode, a bipolar
mode, or a combination of both and can be switchable between the two” (FF
6 (emphasis added); Cf. Reply Br. 6 (“Examiner’s interpretation of Morris
fails to take into account that the monopolar and bipolar modes are two
different modes of operations that are intended for different treatment
locations and hence different target ablation volumes”)). As Appellant
explains, when one of Morris’ electrodes fails an impedance test, Morris’
device “changes the mode of operation to bipolar mode . . . where only
surface irradiation of the tissue occurs for the electrode that failed the
impedance test” (Reply Br. 7 (emphasis added)). Therefore,
notwithstanding Appellant’s contention to the contrary, Morris permits the
device to deviate, at least to some extent, from “an intended target
geometry,” while still providing treatment (Cf. Reply Br. 6).
As discussed above, Morris suggests that the delivery of RF energy
can be modified if an impedance value exceeds a predetermined value (see
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FF 9; Reply Br. 7). Morris also suggests that the delivery of RF energy can
be interrupted if an impedance value exceeds a predetermined value (FF 9).
This supports Examiner’s reasoning that Morris implicitly suggests, and
makes obvious, that a person of ordinary skill in this art would “make sure a
pre-determined number of electrodes passed the impedance tests, because
doing so would ensure that the tissue wasn’t damaged and that the tissue still
received a meaningful treatment” (Ans. 12).
Appellant’s claim 1 requires the claimed medical device to comprise a
controller that (1) tests an electrode impedance level, (2) determines whether
an electrode failed an impedance test, and (3) supplies energy to functioning
electrodes when a predetermined percentage of electrodes pass the
impedance test (Appellant’s claim 1). Therefore, the controller of
Appellant’s device, like Morris’ device, supplies energy to functioning
electrodes when a predetermined percentage of electrodes pass the
impedance test (see FF 6 and 9).
We agree with Appellant that “Morris teaches . . . a way to
reconfigure the device such that the electrodes do not fail the impedance test
when treatment is being carried out” (Reply Br. 8). We are not, however,
persuaded by Appellant’s contention that “[t]o modify Morris to supply
energy to functioning electrodes when a predetermined percentage of
electrodes pass the impedance test implies that treatment would be initiated
even if some deployed electrodes fail” (App. Br. 10). Appellant’s and
Morris’ device both recognize when an electrode fails an impedance test.
Appellant’s claim 1 does not exclude the controller from changing the mode
in which energy is supplied to an electrode that failed the impedance test
prior to supplying energy (see Appellant’s claim 1). Therefore, we are not
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persuaded by Appellant’s contention that the device of Appellant’s claim 1
differs from Morris’ device because Morris’ “bipolar mode of operation
avoids [supplying energy to functioning electrodes when an electrode fails
the impedance test] by reconfiguring the device to redirect the current flow
in the tissue such [that] the electrodes would no longer fail the impedance
test when treatment is being carried out” (Reply Br. 7; see also App. Br. 11
(“[n]othing in Morris suggests that a meaningful treatment could be
achieved if there are some failed electrodes”)).
We agree with Appellant’s contention that in Morris’ device “[o]nce
the electrode has been switched to the bipolar mode of operation, that
electrode which previously failed the impedance test would no longer fail
the impedance test” (id.). As discussed above, the device of Appellant’s
claim 1 does not exclude switching the mode of operation of an electrode
that failed an impedance test prior to supplying energy. Stated differently,
and notwithstanding Appellant’s contention to the contrary, the device of
Appellant’s claim 1, like Morris’ device, encompasses a device that (1) tests
an electrode impedance level, (2) determines whether an electrode failed an
impedance test, (3) switches the operating mode of the electrode that failed
the impedance test, and (4) supplies energy to functioning electrodes when a
predetermined percentage of electrodes pass the impedance test (Cf. Reply
Br. 7 (“Morris does not teach or suggest supplying the electrodes with
energy when an electrode fails the impedance test”). As discussed above,
Morris suggests that when measured impedance values exceed a
predetermined value “delivery of RF energy can be . . . modified or
interrupted” (FF 9).
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For the foregoing reasons, we are not persuaded by Appellant’s
contention that Morris suggests “avoid[ing] treatment when an electrode
fails the impedance test” (Reply Br. 7; id. at 8). For the same reasons, we
are not persuaded by Appellant’s contention that “modifying Morris’[]
device [as proposed by Examiner] . . . would render the device
unsatisfactory for its intended purpose because the modification would
reduce the precision in which the resulting ablation volume would match the
intended target ablation volume” (id.; App. Br. 9; Cf. FF 8; Ans. 12). We
are also not persuaded by Appellant’s contention that Examiner relies on
improper hindsight reasoning (App. Br. 11; Cf. Ans. 12 and 17).

Claim 2:
Appellant’s claim 2 depends from and further limits claim 1 to require
that, inter alia, the needle electrode remains recessed within the main
chamber when the needle pierces the portion of the skin (Appellant’s claim
2). Examiner finds that “Morris teaches that the needles are at least
partially recessed in the main chamber at all times” (FF 10 (emphasis
added)). This, however, fails to account for Appellant’s claimed invention,
which requires, inter alia, the needle electrode remains recessed, not at least
partially recessed, within the main chamber when the needle pierces the
portion of the skin (see Appellant’s claim 2; Cf. FF 10).

Claim 18:
Appellant’s claim 18 depends from and further limits claim 14 to
require, inter alia, that a distal portion of each of the electrodes remains
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recessed within the housing when each of the electrodes pierces the portion
of the skin (Appellant’s claim 18).
Examiner finds that Appellant “does NOT define ‘distal portion’ in
the context of each electrode. Therefore, Examiner interprets ‘distal portion’
to be from the distal piercing tip to the middle of the electrode” (FF 13). We
are not persuaded. Morris suggests that “[p]ushable member 19 has [a]
proximal and a distal portion 19p and 19d[, wherein] . . . [a]t least a portion
of distal portion 19d comprise[s] electrode 18” (FF 11-12). As illustrated in
Morris’ FIG. 21 pushable member 19 extends to a region outside of Morris’
housing (FF 11). Examiner failed to establish an evidentiary basis on this
record to support a conclusion that Morris suggests that a distal portion of
each electrode, which is associated with at least a portion of the distal
portion 19d of Morris’ pushable member 19, remains recessed within the
device’s housing when the electrodes pierces tissue (see FF 11-12; Cf.
Appellant’s claim 18; Reply Br. 9 (“even under the Examiner’s
interpretation of ‘distal portion,’ Morris still fails to show that a distal
portion of each of the electrodes remains recessed within the housing”)).

The combination of Morris and Utely:
Based on the combination of Morris and Utely, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie obvious to (1) “include the return electrode of Utely with the invention
of [Morris], because return electrode would give [Morris’] invention some
measurement of current in the skin in order to monitor or improve the
therapy,” (2) “include the spacers of Utely with the invention of Morris
because doing so would more uniformly distribute the electrodes’ energy
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over a treatment area,” and (3) “make the chamber height greater than the
length of the needles in order to protect the needles from damage and
because Morris’[] invention uses negative pressure to increase contact
between the membrane of the device and the [tissue], thereby enabling better
contact with the needles” (Ans. 14-15; FF 14).
Having found no deficiency in Examiner’s reliance on Morris, we are
not persuaded by Appellant’s contention that “Utely fails to remedy the
shortcomings of Morris” (App. Br. 12).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with regard to claims 1 and 3.
The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over Morris is affirmed. Claims 4-8, 14, 19, and 25-45 fall with claim 1.
The rejection of claim 3 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Morris and Utely is affirmed. Claims 15-17 fall
with claim 3.
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness with regard to claims 2 and 18. The
rejection of claims 2 and 18 under 35 U.S.C. § 103(a) as unpatentable over
Morris is reversed.

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
Appeal 2012-002145
Application 11/868,833

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