Ex Parte Laeseke et al

Board of Patent Appeals and Interferences

Aug 12, 2008

10021622 (B.P.A.I. Aug. 12, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte
PAUL F. LAESEKE, KELLY ROSE STEVENS, THOMAS C. WINTER,
FRED T. LEE, JR., FRANK J. FRONCZAK,
JOHN G. WEBSTER, and CONNIE L. DAVIS
__________

Appeal 2008-3002
Application 10/021,622
Technology Center 3700
__________

Decided: August 12, 2008
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and LORA M. GREEN,
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 5-8 and 10. We have jurisdiction under
35 U.S.C. § 6(b).

Appeal 2008-3002
Application 10/021,622

STATEMENT OF THE CASE
The claims are directed to a biopsy apparatus that can also cauterize
the biopsy area. Claims 5 and 10 are representative of the claims on appeal,
and read as follows:
5. A biopsy needle assembly comprising:
an introducer shaft having a first and second end, and sized for
percutaneous insertion into a patient along an insertion path to locate the
first end at a biopsy site, the first end having an electrically conductive
surface adapted to be exposed to tissue and communicating by means of an
insulated conductor to the second end to connect with a radio frequency
cauterizing electrical source;
a large area electrode adapted to contact the patient without
production of cauterizing temperatures to complete a circuit through the
radio frequency cauterizing electrical source with the electrically conductive
surface of the introducer shaft through a patient; and
a biopsy needle interfitting with the introducer shaft to be guided
thereby, the biopsy needle including a sampling means for removal of a
tissue sample before cauterization of the insertion path using the electrically
conductive surface;
wherein the electrically conductive surface is a conductive stylet
having a first end supported by the introducer shaft.

10. A biopsy needle assembly comprising:
an introducer shaft having a first and second end, and sized for
percutaneous insertion into a patient along an insertion path to locate the
first end at a biopsy site, the first end having an electrically conductive
surface adapted to be exposed to tissue and communicating by means of an
insulated conductor to the second end to connect with a radio frequency
cauterizing electrical source;
a large area electrode adapted to contact the patient without
production of cauterizing temperatures to complete a circuit through the
radio frequency cauterizing electrical source with the electrically conductive
surface of the introducer shaft through a patient; and
a biopsy needle interfitting with the introducer shaft to be guided
thereby, the biopsy needle including a sampling means for removal of a
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tissue sample before cauterization of the insertion path using the electrically
conductive surface;
further including a temperature sensor positioned at the electrically
conductive surface.

The Examiner relies on the following references:
Roberts US 6,261,242B1 Jul. 17, 2001
Lennox US 5,122,137 Jun. 16, 1992

We affirm-in-part.

ISSUE (Anticipation)
The Examiner contends that claim 5 is anticipated by Roberts.
Appellants contend that Roberts fails to teach any element equivalent
to a stylet.
Thus, the issue on appeal is: Does Roberts teach a biopsy needle
assembly that includes a stylet as required by claim 5?

FINDINGS OF FACT (FF)
FF1. Claim 5 stands rejected under 35 U.S.C. § 102(e) as being anticipated
by Roberts.
FF2. The Examiner relies on Roberts for teaching a biopsy sampler which
cauterizes the biopsy site after the biopsy is taken (Ans. 3; Roberts Figures
4a-4c).
FF3. According to the Examiner, the sampler includes “an introducer shaft
(50) that is a hollow tube that is sized for insertion into the patient along an
insertion path to locate a first end of the tube at the biopsy site,” wherein a
“biopsy needle (14) (see Column 6, lines 51-52) including a sampling means
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(30) is fit in the introducer shaft to be guided thereby.” (Ans. 3.) Roberts is
also cited for teaching that the first end of the introducer shaft includes an
electrically conductive surface (22) on a conductive stylet (12) “having a
first end supported by the shaft that is adapted to be exposed to tissue and
communicates by means of an insulated conductor (28) (see Column 4, lines
46-48) with a radio frequency cauterizing electrical source (see Column 4,
lines 40-41).” (Ans. 3, 6.) Roberts is further cited for teaching that a “large
area electrode is adapted to contact the patient without production of
cauterization temperatures to complete a circuit when a monopolar electrode
is used (see Column 6, lines 38-46).”
FF4. As to a “stylet,” the Specification teaches that “a guide may be
employed for the biopsy needle comprising a sharp rod (stylet) that is
housed inside a hollow cylindrical tube (introducer needle).” (Spec. ¶ 0006.)
FF5. Figure 4a of Roberts, as relied upon by the Examiner, is reproduced
below:

Figure 4a shows a side view of the distal portion of the biopsy assembly of
Roberts disposed within an endoscope (Roberts, col. 4, ll. 17-19). Reference
numeral 12 is a sheath (see, e.g., Roberts col. 6, l. 60), but cannot be said to
be a sharp rod.
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PRINCIPLES OF LAW
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).
Moreover, during prosecution before the Office, claims are to be
given their broadest reasonable interpretation consistent with the
Specification as it would be interpreted by one of ordinary skill in the art.
In re American Academy of Science Tech Center, 367 F.3d 1359, 1364 (Fed.
Cir. 2004).

ANALYSIS
The Examiner, quoting the Merriam-Webster online dictionary,
defines stylet as “a ‘slender medical probe’ or ‘a thin wire inserted into a
catheter to maintain rigidity or into a hollow needle to maintain patency.’”
(Ans. 6.) While claims are given their broadest reasonable interpretation
during prosecution before the office, that interpretation has to be consistent
with how the ordinary artisan would interpret the term in view of the
Specification. In the case before us, the Specification clearly equates the
stylet with a sharp rod (FF4), and reference numeral 12 of Figure 4a of
Roberts cannot be said to be a sharp rod (FF5). Thus, the Examiner has not
established that Roberts teaches every element of claim 5.

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CONCLUSION
Thus, we find that the Examiner has not set forth a prima facie case
that claim 5 is anticipated by Roberts, and the rejection is reversed.

ISSUE (Obviousness)
The Examiner contends that claims 5-8 and 10 are rendered obvious
by the combination of Roberts and Lennox.
Appellants contend that the combination of Roberts and Lennox does
not teach all of the elements of the rejected claims.
Thus, the issue on appeal is: Has the Examiner set forth a prima facie
case that claims 5-8 and 10 are rendered obvious by the combination of
Roberts and Lennox?

FINDINGS OF FACT
FF6. Claims 5-8 and 10 stand rejected under 35 U.S.C. § 103(a) as being
obvious over the combination of Roberts and Lennox.
FF7. Claims 6-8 are dependent on claim 5. Claim 10 is a second
independent claim that does not require the stylet of claim 5.
FF8. Roberts is relied upon for the teachings set forth above with respect to
the anticipation rejection (see FF2 and FF3).
FF9. The Examiner finds that Roberts does not teach including a
temperature sensor (29, 36) positioned at the electrically conductive surface
(28, 35) (Ans. 5).
FF10. Lennox is cited for teaching disposing a temperature sensor at the
electrically conductive surface “in order to provide an indirect means of
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measuring and controlling the temperature of the tissue surrounding the
electrode, so as to prevent excessive tissue damage.” (Ans. 5.)
FF11. Figure 1 of Roberts is shown below.

Figure 1 shows a biopsy assembly including a resecting device and a
cauterizing sheath (col. 4, ll. 5-6).
FF12. The biopsy assembly 10 includes a cauterizing sheath 12, wherein a
pair of bipolar electrodes 22a, 22b, are mounted on the outer sheath surface
13 near distal end 20 (Roberts col. 4, ll. 33-44). The sheath 12 also has an
electrical connector 24 for connection to an radio frequency (RF) generator,
and two wires 28 are disposed within the lumen 26 connecting the electrodes
22a and 22b to the electrical connector 24 (id. at ll. 30-46). The wires are
covered with a layer of electrical insulation to prevent electrical contact
between the two of them (id. at ll. 47-48). RF energy may be applied to the
electrodes 22a and 22b through wires 28 and electrical connector 24, causing
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current to pass through the resecting site tissue between 22a and 22b (id. at
col. 6, ll. 14-17). The current heats the resecting site to about 60-100°C,
which is sufficient to coagulate the resecting site tissue (id. at ll. 17-19).
FF13. Moreover, the sheath need not actually be used for percutaneous
insertion, but only need be “sized for percutaneous insertion into a patient.”
(Claims 5 and 10.) Roberts teaches that the outer diameter of the sheath may
be 2.6 mm (Roberts, col. 5, ll. 41-42), and Appellants have not provided any
evidence that 2.6 mm is too large to be used for percutaneous insertion.
FF14. Thus, Roberts teaches:
an introducer shaft [sheath 12] having a first and second
end, and sized for percutaneous insertion into a patient along an
insertion path to locate the first end at a biopsy site, the first end
having an electrically conductive surface adapted to be exposed
to tissue [distal end 20 of shaft 10] and communicating by
means of an insulated conductor [wires 28] to the second end to
connect with a radio frequency cauterizing electrical source;
[and]
a large area electrode [electrodes 22a and 22b] adapted to
contact the patient without production of cauterizing
temperatures to complete a circuit through the radio frequency
cauterizing electrical source with the electrically conductive
surface of the introducer shaft through a patient.

(Claims 5 and 10.)

FF15. Roberts further teaches that the working lumen 16 of sheath 12 of
biopsy assembly 10 is sized to receive a resecting device 14 (Roberts, col. 4,
ll. 35-37). The resecting device 14 includes a cutter such as forceps (30)
(Roberts, col. 4, ll. 49-51), and may also contain a needle (not shown) to
assist in resecting tissue samples (id. at col. 6, ll. 51-52). The cutter device
14 is withdrawn within working lumen 16 before the site is cauterized by the
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electrodes, preventing the heat at the resecting site from coagulating the
tissue specimen (id. at col. 6, ll. 8-28).
FF16. We thus find that Roberts also teaches “a biopsy needle interfitting
with the introducer shaft to be guided thereby, the biopsy needle including a
sampling means for removal of a tissue sample before cauterization of the
insertion path using the electrically conductive surface” (Claims 5 and 10).
FF17. Lennox teaches the use of a temperature sensor positioned at an
electrically conductive surface (Lennox Abstract). The sensor thus “detects
and, by feedback, controls the temperature of the electrode, as an indirect
means of measuring and controlling the temperature of tissue contacting the
electrode.” (Id. at col. 2, ll. 39-42.) The feedback process ensures that the
tissue is not overheated, allowing the heating process to be predictable and
uniform (id. at col. 8, ll. 17-26).

PRINCIPLES OF LAW
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).
The Supreme Court has recently emphasized 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.” KSR
Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007). “The combination of
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familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results.” Id. at 1739. Moreover, 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).

ANALYSIS
As to claim 5-8, as Lennox does not remedy the deficiencies of
Roberts as to the stylet, we conclude that the Examiner has not set forth a
prima facie case of obviousness as to those claims, and we therefore reverse
the rejection as to those claims.
Claim 10, however, stands on a different footing. Claim 10 does not
require a stylet (FF7). Roberts teaches all of the limitations of claim 10
(FF14 and FF16) except for the temperature sensor (FF9). Lennox teaches
the use of a temperature sensor positioned at an electrically conductive
surface that allows for predictable and uniform heating of the tissue
surrounding the electrode (FF17). Thus, it would have been obvious to
position a temperature sensor positioned at the electrically conductive
surface of the biopsy assembly of Roberts in order to obtain predictable and
uniform heating of the resected tissue. We therefore conclude that claim 10
is rendered obvious by the combination of Roberts and Lennox, and thus
turn to Appellants’ arguments in rebuttal.
Appellants argue that Roberts, “by inserting the biopsy assembly into
the colon and through an endoscope, further teaches away from the need for
an element to pierce the skin and the creation of an insertion path that would
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require cauterization.” (App. Br. 11.) Thus, Appellants assert, “it is not
necessary, and indeed not desirable, to include an element to pierce the skin
for insertion, and the only cauterization required, and discussed is
cauterization of the biopsy site.” (Id.).
Appellants’ arguments are drawn to the intended use of the biopsy
assembly, and not the biopsy assembly itself, which is the subject of claim
10. For example, the argument regarding cauterization of the insertion path
is an argument as to intended use, and not the structure of claim 10.
Moreover, as to the argument as to the inclusion of an element to pierce the
skin for insertion, there is nothing in claim 10 that requires an element to
pierce the skin.

CONCLUSIONS OF LAW
As Lennox does not remedy the deficiencies of Roberts as to claim 5,
we conclude that the Examiner has not set forth a prima facie case of
obviousness as to claim 5, nor the claims dependent thereon, i.e., claims 6-8,
and thus reverse the obviousness rejection as to claims 5-8.
We do conclude, however, that the combination of references relied
upon by the Examiner renders obvious the biopsy assembly of claim 10, and
we therefore affirm the rejection as to that claim.

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TIME LIMITS
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv) (2006).

AFFIRMED-IN-PART

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