Ex Parte Kadykowski et al

Board of Patent Appeals and Interferences

May 22, 2012

11710370 (B.P.A.I. May. 22, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/710,370 02/23/2007 Randal James Kadykowski 0144(17129) 4869
46909 7590 05/22/2012
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
ATTN: GAEL DIANE TISACK
6200 JACKSON ROAD
ANN ARBOR, MI 48103
EXAMINER
CRONIN, ASHLEY L
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
05/22/2012 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RANDAL JAMES KADYKOWSKI and
LYNE MADELEINE CHARRON-KELLER
__________

Appeal 2011-001697
Application 11/710,370
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to a device for dissecting and/or harvesting a blood vessel.
The Patent Examiner rejected the claims for anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
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STATEMENT OF THE CASE
Claims 1-14 and 21-26 are on appeal. (App. Br. 5.)1 Claim 1 is
representative and reads as follows:
1. A device for dissecting a vessel from any surrounding vessel branch
and/or for harvesting the vessel, the device including:
a capture tool having a capture tube and a capture ring at a distal end
of the capture tube, the capture ring being configured to be at least partially
positioned around a first portion of the vessel and to releasably hold the first
portion of the vessel within the capture ring; and
a sealing tool having a sealing tube and a sealing ring at a distal end of
the sealing tube, the sealing ring being configured to receive a second and
adjacent portion of the vessel and to releasably hold the second portion of
the vessel within the sealing ring,
the sealing tool being capable of being at least axially movable with
respect to the capture tool, the sealing ring and the capture ring being
configured to: i) releasably hold the branch, and ii) to cauterize a branch
from the vessel and to at least seal the cauterized branch.

The Examiner rejected the claims as follows:
 claims 1-5, 7-12, and 21-26 under 35 U.S.C. § 102(b) as anticipated
by Bennett (US 6,019,771, issued Feb. 1, 2000);
 claim 6 under 35 U.S.C. § 103(a) as unpatentable over Bennett and
Truckai (US 2003/0055417 A1, published March 20, 2003); and
 claims 13 and 14 under 35 U.S.C. § 103(a) as unpatentable over
Bennett and Shikinami (US 6,281,262 B1, issued Aug. 28, 2001).

1 The Appeal Brief is inconsistent about which claims are appealed.
Contrast the partial list at pages 2 (Status of Claims) and 10 (Conclusion),
with page 5 (Grounds of Rejection to be Reviewed) where all rejected
claims are listed. We assume page 5 is correct.
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ANTICIPATION
The Issue
A. Claim 1
The Examiner’s position is that Bennett described a device for
dissecting a vessel from any surrounding vessel branch and/or for harvesting
the vessel. (Ans. 3.) The Examiner identified the features of the Bennett
device that anticipate the features in Appellants’ device. (Id. at 3-7.)
Appellants do not dispute that the elements claimed in their own
device correspond to the elements in Bennett’s, but argue that Bennett’s
device lacked a capability their own device possesses. Specifically,
Appellants contend that “the Bennett reference neither discloses nor is
capable of providing the present invention's function to releasably hold a
branch between the rings without damaging the branch as recited in claim
1.” (App. Br. 6.) According to Appellants, bringing Bennett’s blade
members together results in severing the branch vessel, and the blade
members could not releasably hold the branch vessel. Appellants point to
Specification ¶ 35 as describing the rings as releasably holding the branch
vessel without damaging it. (Id.) Thus, Appellants argue the rejection
should be reversed because “[i]n contrast to the present invention, the
Bennett disclosure in no way teaches nor infers the functionality of
releasably holding a branch vessel between its blade members without
damaging the branch vessel.” (Id.)
The issues with respect to this rejection are:
whether Bennett’s blade members could releasably hold a branch
vessel; and if so,
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whether claim 1 defines a device that must releasably hold a branch
vessel between the rings without damaging it; and, if so,
whether Bennett’s blade members could releasably hold a branch
vessel without damaging it.
Findings of Fact
1. Bennett’s patent is titled “Devices And Methods For Minimally
Invasive Harvesting Of A Vessel Especially The Saphenous Vein For
Coronary Bypass Grafting.”
2. Bennett’s Figure 1 is reproduced here:

“FIG. 1 is a basic scissors mechanism having, in this example, two
cooperating blade members where the more distal blade member
separates a vessel from the surrounding tissue, and where the blade
members can used together to sever side branches of a vessel by
positioning the side branch between the two blade members.”

(Bennett, col. 2, ll. 46-52.)
3. Bennett disclosed:
Attached near the proximal end, meaning near or at the handle 1 are
means for remote actuation of the scissors mechanism such as a
plurality of rods 2 or rigid wires 3 running from the handle to the
scissors mechanism. At least one of the rods 2 or rigid wires 3 may be
affixed to the handle 1 to allow precise positioning.
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(Id. at col. 4, ll. 53-59.)
4. Bennett disclosed:
In one embodiment, the scissors mechanism is comprised of two blade
members 4, 5 each of which may be generally circular in shape but
having an interruption or opening 6 therein such that both of the blade
members 4, 5 may be positioned to substantially surround a tubular
vessel structure such as the saphenous vein.

(Id. at col. 4, l. 65 – col. 5, l. 3.)
5. Bennett disclosed:
Selective movement of each blade member 4, 5 provides the
capability to sever the side branches extending at any angle from the
major saphenous vein. Thus, pursuant to this embodiment of the
invention, the side branches may severed by passing the distal blade
member 4 over the segment of the vessel where the side branch exists
while rotating the distal blade member 4, allowing the side branch to
pass through opening 6, rotating the distal blade member 4 in either
direction and then bringing the leading edge 9 of the second blade
member 5 into contact with the trailing edge 8 of the first blade
member 4. Thus, any tissue structure extending from the side of a
vessel may be severed by positioning the structure between the blade
members 4, 5 either by rotation of the handle 1, or by independent
rotation of the remote actuation means 2, 3 followed by bringing the
blade members 4, 5 together or in sufficient proximity to sever the
side vessel.

(Id. at col. 5, ll. 41-44.)
6. Bennett disclosed: “The vessel severing function may be enhanced by
providing bipolar blade members 4, 5 where opposite electric charges
are applied to the respective members.” (Id. at col. 5, ll. 41-44.)

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Principles of Law
“[W]hile it is true that claims are to be interpreted in light of the
specification . . . , it does not follow that limitations from the specification
may be read into the claims. . . . It is the claims that measure the invention.”
Sjolund v. Musland, 847 F.2d 1573, 1581-82 (Fed. Cir. 1988) (emphasis in
original, citation omitted).
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In
re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations
omitted). “A patent applicant is free to recite features of an apparatus
either structurally or functionally. . . . Yet, choosing to define an
element functionally, i.e., by what it does, carries with it a risk. As our
predecessor court stated:
where the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the claimed
subject matter may, in fact, be an inherent characteristic of the prior
art, it possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the
characteristic relied on.

Schrieber at 1478 (citation omitted).

Analysis
The Examiner found, and we agree, that Bennett’s blade members can
releasably hold a branch vessel. Bennett taught the branch vessel must first
be positioned between the blade members by “positioning the [branch
vessel] between the blade members 4, 5 either by rotation of the handle 1, or
by independent rotation of the remote actuation means 2, 3.” (FF 5.) After
positioning, the blade members can be brought “together or in sufficient
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proximity to sever the side vessel” (FF 5), similar to the way in which, after
positioning, the blades of a scissors are brought together or in sufficient
proximity to sever something. Bennett described the device as capable of
“precise positioning.” (FF 3.) We agree with the Examiner that Bennett’s
blades have the same capability, like scissor blades that can hold an object
without severing it, and can be moved to a different position on the object
before a cut is made.
Appellants further contend that that the claimed device must
releasably hold a branch vessel between the rings “without damaging it.”
The feature “without damaging it” is not recited in the claims, and it is not
imported from the Specification to limit the claims. As it is not a claimed
limitation, it is unnecessary to decide whether Bennett’s blades can hold a
vessel without damaging it.
We find the rejection’s evidence sufficient to have shifted the burden
to Appellants to show “that the prior art structure did not inherently possess
the functionally defined limitations of his claimed apparatus.” Schrieber,
128 F.3d at 1478.
Claims 2-5, 7-12, 21, and 24 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

B. Claims 22 and 23
Appellants dispute whether Bennett described “the device being
capable of releasably holding, and subsequently cauterizing the branch . . .”
as recited in claims 22 and 23. (App. Br. 6-8.)
First, Appellants repeat the argument that Bennett’s device is not
capable of releasably holding the branch, but that argument was found
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unpersuasive for the reasons explained above with regard to claim 1. (App.
Br. 6.)
Next, Appellants contend that “[c]laim 22 is further distinguishable
from Bennett on the basis that claim 22 recites, ‘the device is capable of
releasably holding, and subsequently cauterizing, the branch.’” (Id. at 7.)
Appellants point to Bennett’s disclosure that “[t]he vessel severing function
may be enhanced by providing bipolar blade members 4, 5 where opposite
electric charges are applied to the respective members.” (Id., quoting
Bennett, col. 5, ll. 41-44.) Appellants contend this is evidence that Bennett
disclosed using electrical energy to enhance the severing function, but
“Bennett does not disclose cauterization as a step subsequent to holding the
branch as does the present invention.” (Id.) The Examiner responds: “the
sealing and capturing rings 4, 5 exemplified in Figure 1 of Bennett et al. are
releasably holding the vessel therein (before the ‘scissor action’ occurs) and
subsequently cauterize the branch when the rings are brought into direct
contact and the electrical energy is applied (cauterizing the branch).” (Ans.
9.)
We find the Examiner has the more reasonable interpretation of the
reference. Bennett explained that the blade members would first be
positioned around the vessel, and then brought into sufficient proximity to
sever the vessel. (FF 5.) Bennett taught how to achieve precise positioning.
(FF 3.) The operator would not logically engage the cauterizing mechanism
until after the vessel was held in the desired position. Re-positioning to a
desired position would have been within ordinary skill in view of Bennett’s
instructions.

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C. Claims 25 and 26
Claims 25 and 26 further limit the device of claim 24 by defining the
rings as having “generally planar surfaces whereby, when the sealing ring is
adjacent to the capture ring, the generally planar surfaces are configured to
releasably hold the branch of vessel without substantially damaging the
branch or vessel.”
Appellants contend “[t]here is a clear distinction between the flat
surfaces of the present invention's rings, which are expressly configured to
releasably hold the branch without damaging it, versus the blade members
of Bennett which have sharpened edges to form a scissors mechanism for
severing.” (App. Br. 8.) The Examiner responds: “the inner circumference
surfaces of [Bennett’s] capture and sealing rings 4, 5 are generally planar
surfaces that releasably hold the vessel therein.” (Ans. 9.)
We find Appellants’ position is more consistent with the evidence.
Bennett’s leading and trailing edges 9 and 8, not the inner circumferences,
make contact with and hold the vessel. (FF 5.) Further, there is no evidence
that a person of ordinary skill in the art would have considered either the
cutting edges or the inner circumferences to be planar.

OBVIOUSNESS
A. Claim 6
Claim 6 further limits the device of claim by reciting “the sealing tool
comprises an ultrasonic cauterizing tool.”
The Examiner’s position is that although Bennett did not use
ultrasonic energy for cauterizing, “Truckai et al. teaches the use of a
waveguide 140 (paragraph [0058]) advanced over jaw elements such that the
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jaw elements are able to deliver ultrasonic energy in order to coagulate, seal,
or weld small blood vessels (paragraph [0058]).” (Ans. 7.)
Appellants reiterate their contention that “Bennett lacks the teaching,
suggestion, or motivation for the need or the capability to releasably hold
vessel branches” and argue “Truckai adds nothing in that regard.” (App. Br.
8-9.) Appellants state:
The supplemental energy supplied to the blade members, whether that
energy be electrical (as in Bennett) or ultrasonic (as in Truckai),
serves only to enhance the preexisting severing function. The severing
function being enhanced is still the fundamental scissors mechanism.
The distinctions between Bennett's scissors mechanism and the
present invention's capability to releasably hold without damaging a
branch vessel is described above. The teachings of Truckai do not
address those fundamental operational differences. Therefore, Bennett
in view of Truckai does not render claim 6 obvious.

(Id. at 9.)
The Examiner responds that “Truckai was merely used to teach that
an ultrasonic cauterizing tool is well known in the art and that the sealing
tool of Bennett et al. (which cauterizes due to electrical energy applied
thereto) can be that of the ultrasonic type.” (Ans. 9.)
Findings of Fact
7. Truckai’s patent is “Surgical System For Applying Ultrasonic Energy
To Tissue.”
8. Truckai disclosed:
The waveguide when advanced over the jaw elements to any partly
extended position can still acoustically couple sufficiently with the
jaws to delivery ultrasonic energy to tissue for purposes of
coagulation, sealing or welding of small blood vessels. Thus, it is
contemplated that the jaw structure can be used effectively in
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surgeries as a general tool for grasping, dissecting and cauterizing
tissues . . . .

(Truckai 6, ¶ 58.)
Analysis
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
There is no dispute that replacing electrical energy with ultrasonic
energy to cauterize a branch vessel would have been obvious. Instead,
Appellants again contend that Bennett’s cutting edges did not have the
capability of releasably holding a vessel. We disagree, for the reasons
discussed in the anticipation section above.

B. Claims 13 and 14
Claims 13 and 14 further limit the device of claim 1 by reciting “at
least the sealing ring is configured to be reduced in diameter,” and “at least
the sealing ring is made of a shape memory alloy,” respectively.
The Issue
The Examiner’s position is that Bennett did not teach a sealing ring
configured to be reduced in diameter, or made of a shape memory alloy, but
“Shikinami teaches a vascular ligating/sealing ring 5 (Fig. 8) made of a
shape memory alloy and configured to be reduced in diameter (column 17,
lines 8-20) in order to ligate a blood vessel (column 17, lines 8-20; Figs. 6-
8).” (Ans. 7.)
Appellants contend “Bennett does not provide any teaching,
suggestion, or motivation for the need of the capability to reduce the
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diameter of its blade members 4 and 5,” and “it is not the present invention's
object to constrict or ‘tightly ligate’ the vessel as in Shikinami.” (App. Br.
9.)
The Examiner responds that “the intended use of the present invention
is irrelevant when the structure is met by prior art,” and “one of ordinary
skill in the art can appreciate that a reduction in the ring diameter once the
vessel is held therein would be advantageous to keeping it held therein for
the subsequent cauterizing that occurs.” (Ans. 10.)
Further Findings of Fact
9. Shikinami’s patent is titled “Shape-Memory, Biodegradable And
Absorbable Material.”
10. Shikinami disclosed:
This shape-memory material for vascular ligation (5) in the shape of a
large diameter ring is put into the end of a blood vessel and reheated
by bringing into contact with a hot air stream or hot water (sterilized
physiological saline) at deformation temperature (Tf) or above. As a
result, it is immediately recovered to the original shape of a small
diameter ring and thus the end of the blood vessel can be tightly
ligated, thus achieving stanching.

(Shikinami, col. 17, ll. 13-20.)
Principles of Law
An invention
composed of several elements is not proved obvious merely by
demonstrating that each of its elements was, independently, known in
the prior art….[I]t can be important to identify a reason that would
have prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention does.

KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
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Analysis
Appellants’ arguments are persuasive. See App. Br. 9-10. We reverse
for the reasons stated in Appellants’ Brief.

SUMMARY
We affirm the rejection of claims 1-5, 7-12, and 21-24 under
35 U.S.C. § 102(b) as anticipated by Bennett.
We reverse the rejection of claims 25 and 26 under 35 U.S.C. § 102(b)
as anticipated by Bennett.
We affirm the rejection of claim 6 under 35 U.S.C. § 103(a) as
unpatentable over Bennett and Truckai.
We reverse the rejection of claims 13 and 14 under 35 U.S.C. § 103(a)
as unpatentable over Bennett and Shikinami.

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

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