Ex Parte Kim et al

Patent Trial and Appeal Board

Jul 31, 2013

11698801 (P.T.A.B. Jul. 31, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DAVID KIM, THOMAS DAIGLE, DARRIN DICKERSON,
JAMES SKARDA, ADAM PODBELSKI, and MARK BILITZ
__________

Appeal 2012-006880
Application 11/698,801
Technology Center 3700
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for lack of written description, lack of claim clarity, and
obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF CASE
1. A device for ablating tissue at a desired location in a body, the device
comprising:
a pair of floating jaws moveable between a spaced apart open position
and a closed position, the pair of jaws comprising at least one ablating
element for ablating tissue located between the jaws;
a handle comprising controls for remotely controlling the movement
of the jaws and the at least one ablative element; and
a flexible neck connecting the jaws and handle, wherein the neck is
floppy in nature so as to be sufficiently flexible along a length of the neck so
as to permit the neck to be flexed along its length for changing the curvature
of the neck along a delivery path without respect to where the jaws and the
handle are oriented and positioned relative to one another.

9. A device for ablating tissue, the device comprising:
a pair of independently floating jaws moveable between a spaced apart open
position and a closed position, the pair of jaws comprising at least one
ablating element for ablating tissue located between the jaws, wherein the
open position of the jaws is scissor-like in configuration and the closed
position is parallel in configuration and as the jaws are moved from the open
position to the closed position, the jaws follow a guided path including a
first portion that causes the jaws to move in a scissor-like manner initially
and then a second portion that causes the jaws to move in a parallel manner,
wherein when following the guided path, the jaws are adjustable in
orientation relative to one another based upon counter-pressure that may be
applied to the jaws from engagement with tissue, the jaws thus being able to
independently float to accommodate variations in tissue;
a handle comprising controls for remotely controlling the movement
of the jaws and the at least one ablative element; and
a neck connecting the jaws and handle.

Cited References

Latterell et al. US 2006/0271042 A1 Nov. 30, 2006
Couture et al. US 2002/0188294 A1 Dec. 12, 2002
Slater US 5,683,388 Nov. 4, 1997
Dalbec et al. US 7,200,445 B1 Apr. 3, 2007
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Mulier et al., US 2002/0169446 A1 Nov. 14, 2002
Parker et al., US 2002/0032408 A1 Mar. 14, 2002

Grounds of Rejection

1. Claims 1-8 and 21 are rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement.
2. Claims 1-8 and 21 are rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which applicant regards as the invention.
3. Claims 9, 12-16 and 20 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Latterell as in view of Couture.
4. Claims 1-2, 4-8, 10 and 22 are rejected under 35 U.S.C. §103(a) as
being unpatentable over Latterell in view of Couture, Slater and Dalbec.
5. Claim 3 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Latterell in view of Couture, Slater and Dalbec, as applied to claim 1
above and further in view of Mulier.
6. Claim 21 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Latterell in view of Couture, Slater and Dalbec, as
applied to claim 1 above and further in view of Parker.
7. Claim 11 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Latterell and Couture as applied to claim 9 above, and
further in view of Mulier.
8. Claim 23 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Latterell and Couture as applied to claim 9 above, and
further in view of Parker.
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FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 5-
18.
PRINCIPLES OF LAW
Written Description
The purpose of the written description requirement is to “ensure that
the scope of the right to exclude, as set forth in the claims does not
overreach the scope of the inventor's contribution to the field as far as
described in the patent specification.” Reiffin v. Microsoft Corp., 214 F.3d
1342, 1345 (Fed. Cir. 2000). To that end, to satisfy the written description
requirement, the inventor “must convey with reasonable clarity to those
skilled in the art that, as of the filing date sought , he or she was in
possession of the invention” [first emphasis added]. Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). “One shows that one is
'in possession' of the invention by describing the invention, with all its
claimed limitations” [emphases in original]. Lockwood v. American
Airlines. 107 F.3d 1565, 1572 (Fed. Cir. 1997). It is not necessary for the
specification to describe the claimed invention ipsissimis verbis; all that is
required is that it reasonably convey to those skilled in the art that, as of the
filing date sought, the inventor was in possession of the claimed invention.
Union Oil of California v. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed.
Cir. 2000).
Distinct claiming
Claims are in compliance with 35 U.S.C. § 112, second paragraph, if
“the claims, read in light of the specification, reasonably apprise those
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skilled in the art and are as precise as the subject matter permits.”
Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1385 (Fed.
Cir. 1987).
“The definiteness of the language employed must be analyzed—not in
a vacuum, but always in light of the teachings of the prior art and of the
particular application disclosure as it would be interpreted by one possessing
the ordinary level of skill in the pertinent art.” In re Moore, 439 F.2d 1232,
1235 (CCPA 1971).

Obviousness
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“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).
In KSR, the Supreme Court also addressed the “obvious to try” issue:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
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solutions, a person of ordinary skill has good reason to pursue the
known options within his or her technical grasp. If this leads to the
anticipated success, it is likely the product not of innovation but of
ordinary skill and common sense. In that instance the fact that a
combination was obvious to try might show that it was obvious under
§ 103.

Id. at 421.
Where . . . the claimed and prior art products are identical or
substantially identical, or are produced by identical or substantially
identical processes, the PTO can require an applicant to prove that the
prior art products do not necessarily or inherently possess the
characteristics of his claimed product…. Whether the rejection is
based on “inherency” under 35 U.S.C. § 102, on “prima facie
obviousness” under 35 U.S.C. § 103, jointly or alternatively, the
burden of proof is the same, and its fairness is evidenced by the PTO’s
inability to manufacture products or to obtain and compare prior art
products.

In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added.)

ANALYSIS
Written Description
We do not find that the Examiner has set forth a prima facie case of
lack of written description. The Examiner admits in the Answer, page 6 that
Paragraphs [0016]-[0017] and [0090] of the published
application only refer to the neck of the device as being
flexible. Paragraph [0018] states that there is “a flexible
neck connecting the jaws and handle, wherein the neck is
flexible so as to permit the jaws to be maneuverable in
the body with respect to the handle”. Paragraph [0115]
states that “The neck 22, which attaches the jaw
assembly 20 to the handle 24, is preferably flexible or
“floppy” in nature. In one embodiment, the neck 22 may
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be flexible or floppy like a rope, for example. The
flexible or “floppy” nature may thereby allow a guide
member or device to be used to easily position the jaw
assembly 20 of the ablation device 12 into a position to
ablate tissue”. Lastly, paragraph [0147] states that “In
one embodiment, the guide member 14 or 16 may be
used to safely pull the jaws 28a, 28b of the ablation
device 12 into place if the neck 22 of the ablation device
12 is loose or floppy, e.g., the user cannot actively push
or poke the jaws 28a, 28b into tissue, thereby causing
undesirable tissue damage”.

Fig. 2 of the Appellants’ Specification is reproduced below.

Figure 2 shows Appellants’ ablation device having a floppy neck 22
The Examiner argues that Applicants’ Specification was carefully
reviewed for support, either explicit or implicit, for the limitation of claim 1
that the flexible neck is floppy so as to allow the neck to be flexed and the
curvature changed along a delivery path “without respect to where the jaws
and the handle are oriented and positioned relative to one another,” but none
has been found. (Ans. 6.)
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We are not persuaded. In our view, when one of ordinary skill in the
art reviews the Specification and the indication that the ablation device neck
is “floppy” of “flexible” like a rope, and views Figure 2 of the Specification,
one of ordinary skill in the art would readily understand that “neck is floppy
in nature so as to be sufficiently flexible along a length of the neck so as to
permit the neck to be flexed along its length for changing the curvature of
the neck along a delivery path without respect to where the jaws and the
handle are oriented and positioned relative to one another.” In other words,
the floppy neck of the claimed ablation device does not orient the jaws and
handle to move relative to one another, as shown in Fig. 2 of the
Specification. It is not necessary for the Specification to describe the
claimed invention ipsissimis verbis; all that is required is that it reasonably
conveys to those skilled in the art that, as of the filing date sought, the
inventor was in possession of the claimed invention. Union Oil of California
v. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000). The pending
claim language reasonably conveys to those skilled in the art that, as of the
filing date sought, the inventor was in possession of the claimed invention.
In view of the above, the written description rejection is reversed.

Claim Clarity
The Examiner rejects claims 1-8 and 21 are rejected under 35 U.S.C.
§ 112, second paragraph, as being indefinite for failing to particularly point
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out and distinctly claim the subject matter which applicant regards as the
invention. The Examiner argues that,
It is unclear to the Examiner how the neck, regardless of how
“floppy” it is being interpreted, can flex without respect to the
handle and jaws or their relative positioning when the neck is
connected at one end to the jaws and at the other to the handle. It
is the Examiner's position that the flexing of the neck and the
subsequent changing of the curvature along a delivery path
would occur with at least some degree of respect to the handle
and jaws and their orientation and position relative to one
another. If the neck was a flexible or floppy portion completely
separate or isolated from the jaws and handle, it would be
understandable how it could be flexed without respect to the jaws
or handle but due to the clear connection of the parts in claim 1,
such is not the case.

(Ans. 8.)

We do not find that the Examiner has set forth a prima facie case of
lack of lack of claim clarity under 35 USC §112, second paragraph.
According to Appellants’ Specification page 15, “The ablation device 12
may be used alone or with one or both 10 of the guide members 14, 16,
which may attach or connect to the ablation device 12 and may pull the
ablation device 12 into a desired position where ablation may take place.”
Thus, the guide member of the claimed ablation device pulls the device into
position and does not require movement of the handle of the device to orient
the jaws. One of ordinary skill in the art would understand this from reading
the claims in light of the Specification and therefore the claims do not lack
clarity.
The rejection of the claims under 35 USC § 112, second paragraph is
reversed.
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Obviousness
Discussion
ISSUE
The dispositive issues in the case with respect to the obviousness
rejections of claims 1 and 9 are
1. Whether the combination of Latterell and Couture discloses jaws
that independently float as claimed.
2. Whether the combination of Latterell and Couture discloses a
flexible neck that is floppy in nature that connects the jaws and
handle.

With respect to rejections 3 and 4 in the Grounds of Rejection,
Appellants do not provide separate arguments for individual claims. We
select claims 9 and 1 respectfully, as representative claims with respect to
these rejections. Appellants do not provide separate argument for rejections
5-8, other than arguing the positions taken with respect to claims 1 and 9.
(Br. 20-22.)

Claim 9
Claims 9, 12-16 and 20 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Latterell as in view of Couture.
The Examiner argues that Latterell teaches each element claimed
except
Latterell fails to specifically recite the handle to comprise a
control for controlling the at least one ablative element or that
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control to comprise a trigger. Couture et al discloses a similar
ablative device with a pair of jaws, a handle with associated
controls, and a neck. Couture et al further discloses a trigger
(trigger assembly 70) with associated switch (handswitch 1200)
activating the ablative element. Therefore, it would have been
obvious to incorporate the trigger/handswitch assembly of
Couture et al with the ablative device of Latterell to provide for a
device with remote controls for the jaw movement and energy
application on the handle. Such a device allows for easier and
less complicated use of the device and further allows the user to
easily locate the activation switch, increasing the user's ability to
maintain a field of vision on the treatment area.

(Ans. 10.)
Appellants argue that Latterell lacks any disclosure of jaws that
independently float, as do the jaws of the ablation device of the present
claims. “By floating, a jaw, as claimed, requires the ability to reorient
relative to tissue while also being guided along a specific closing path.” (Br.
17.)

Claim Interpretation
We begin our discussion with interpretation of the claim term
“independently floats.”
During ex parte prosecution, claims are to be given their broadest
reasonable interpretation consistent with the description of the invention in
the specification. See In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989).
Appellants’ Specification page 17 discloses that “The design of the
jaw assembly 20 is preferably configured so that the jaws 28a, 28b close in
an independently floating fashion.” Appellants’ Specification page 23
indicates that, “This arrangement of pins and slots also permits the jaws 28a,
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28b to float to the degree permitted by the interaction of the pins and slots so
that the jaws 28a, 29b can adjust in orientation relative to one another based
upon counter-pressure applied to the jaws surfaces from the engagement
with tissue.” No specific structure or arrangement of pins and slots or
degree of independent floating or movement is present in claim 9 to be
responsible for the independent floating nature of the claimed jaws.
However, Appellants’ Specification would reasonably appear to attribute the
independent floating nature of the jaws generally to a slot and pin
configuration.
While we acknowledge that Fig. 25 of the Specification further shows
one embodiment of the independent floating nature of the jaws, we do not
find that Appellants have claimed such an independent floating nature in a
structural or functional manner which distinguishes from that of the jaws of
Latterell.
Fig. 6 of Latterell is reproduced below.

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Latterell discloses in Figs. 6A-E, the jaw movement based on a slot
and pin system. The Examiner argues that
At most, claim 9 requires that the adjustability in
orientation occurs when the jaws are following the guided path
(lines 8-11 of the claim) but fails to positively recite or limit
how the each of the independently floating jaws accomplish the
adjustment based on counter-pressure that may be applied to
each jaw due to engagement with tissue.
In view of this interpretation above, it is remains the
Examiner's position that the jaws are able to independently float
to accommodate variations in tissue in such an instance as when
either of jaws 26 or 28 of Latterell are in contact with tissue
while the other is out of contact wherein such a condition can
occur dependent on tissue topography and thickness.

(Ans. 23.)
The Examiner contends that
in the course of the jaws of the device of Latterell
closing to contact and/or compress a portion of tissue placed
between the first and second jaws, one of the jaws is capable of
coming into contact with tissue prior to the other due to tissue
of varying thickness and/or topology being placed there
between. In such an instance the Examiner believes that when
one or both jaws come into contact with the tissue, a counter-
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pressure due to the contact between the jaw that is in contact
with the tissue and the tissue itself will occur. As the jaws
continue to move to the closed position, each jaw is capable of
moving relative the tissue dependent upon the level of counter-
pressure applied to the jaw/jaws by the tissue, tissue thickness
and tissue topology while the two jaws are moving in relation to
one another.

(Ans. 24.) The claims before us to do not require any specific degree of
floating and thus a minimal degree of independent action and floating as
described by the Examiner is within the scope of the claim. Both the jaws of
Latterell and those claimed operate on a pin and slot system. There is no
requirement in the claims that such pin and slot system be separate or
unlinked, only that the jaws may minimally act independently. Appellants
claims and arguments do not distinguish the claimed independent floating
jaws from the jaws having the pin and slot system of Latterell. Appellants
provide no convincing rebuttal argument to the minimal floating and
independent jaw activity argument presented by the Examiner. Appellants
have the burden of distinguishing Latterell’s pin and slot system for jaw
movement from the claimed jaw movement which encompasses pin and slot
jaw movement. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). They have
not done so.
Therefore, the rejection of claim 9 is affirmed.

Claim 1
Claims 1-2, 4-8, 10 and 22 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Latterell in view of Couture, Slater and Dalbec.
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We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellants’ arguments as set forth in the Answer. We find
that the Examiner has provided evidence to support a prima facie case of
obviousness. We provide the following additional comment.
Appellants argue, among other things, that the Examiner has engaged
in hindsight reconstruction of Appellants’ invention (Br. 18), that the Slater
reference is an endoscopic device not an ablation device which is
sufficiently rigid to be controlled by a handle portion (Br. 19), and that the
neck of Dalbec is not used for navigational purposes in any sense (Br. 20).
Appellants argue that “Dalbec, column 14, lines 59 to 63 provide that the
rigid sheath 102 allows for advancement within the anatomy, and not the
highly flexible shaft 104.” (Reply Br. 3.)
We are not persuaded by Appellants’ arguments. We agree with the
Examiner that the cited references support that, in the medical instruments
art where internal navigation is required, that it is well known to use a
flexible coil or floppy shaft for navigation (Ans. 26, Slater, cols. 3 and 4.)
Dalbec uses a highly flexible shaft 104 (col. 14, l. 67) or floppy shaft (col.
14, l. 45) to move to a treatment location (col. 14, ll. 54-55.) As stated in
KSR, “When there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp.”
In the present case, Dalbec establishes there is a need in the market for
a floppy or flexible internal navigation means, and the prior art such as
Slater and Dalbec identified predictable solutions which a person of ordinary
skill has good reason to pursue the known options within his or her technical
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grasp, to solve this problem. We find it of no consequence that the Couture
device is an endoscopic device. Therefore, we find no evidence of hindsight
reconstruction of Appellants’ invention on the record before us. Appellants’
other arguments are not persuasive for the reasons of record. Arguments not
made are waived.
We affirm the rejections of claim 1 and other pending rejections for
the reasons of record.

CONCLUSION OF LAW
The written description and 35 USC § 112, second paragraph
rejections are reversed. The Examiner’s obviousness rejections 3-8 are
affirmed.
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

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