Ex Parte Salvas et al

Patent Trial and Appeal Board

Sep 26, 2018

13072329 (P.T.A.B. Sep. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/072,329 03/25/2011
100935 7590 09/28/2018
Dickinson Wright
Smith & Nephew, Inc.
7000 W. William Cannon Drive
Building 1
Austin, TX 78735
FIRST NAMED INVENTOR
Paul L. Salvas
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
PT-3790-US-NP 5764
EXAMINER
HARVEY, TIJLIANNA NANCY
ART UNIT PAPER NUMBER
3733
NOTIFICATION DATE DELIVERY MODE
09/28/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
dwpatents@dickinsonwright.com
Patents.Dept. US@smith-nephew.com
smith-nephew _pair@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAULL. SALVAS and RICHARD M. LUNN 1
Appeal2017-009849
Application 13/072,329
Technology Center 3700
Before JEFFREY N. FRED MAN, MICHAEL J. FITZPATRICK, and
JOHN G. NEW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state that the real party-in-interest is Smith & Nephew, Inc. of
Memphis, Tennessee. App. Br. 3.
Appeal2017-009849
Application 13/072,329
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1, 6-8, 11, 15, and 19. Specifically,
the claims stand rejected as unpatentable under 35 U.S.C. § 112, first
paragraph, for failing to comply with the written description requirement.
Claims 1 and 6-8 also stand rejected as unpatentable under 35 U.S.C.
§ 103 (a) as being obvious over the combination of Golub et al. (US
5,514,133, May 7, 1996) ("Golub") and Kaji (US 6,033,426, March 7, 2000)
("Kaji").
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE and enter a NEW GROUND OF REJECTION.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed generally to surgical cannulas, and
specifically, to an adjustable cannula for effectively engaging a tissue and
for establishing a repeatable instrument path within a patient's body. Spec.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A cannula comprising:
a tubular body having a proximal end and a distal end and
a central axis defined therethrough, the body including axially
extendable bellows configured to enable a length of the tubular
body to adjust along the central axis;
wherein the tubular body has a bore formed therethrough;
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Application 13/072,329
a deformable first protruding member coupled to an outer
surface of a region of the proximal end of the tubular body, the
first protruding member including a first protruding member top
surface and a first protruding member bottom surface, the first
protruding member bottom surface designed to engage an
exterior tissue surface of a body when the deformable first
protruding member is reformed into an original shape; and
a deformable second protruding member coupled to the
outer surface of a region of the distal end of the tubular body, the
second protruding member including a second protruding
member top surface and a second protruding member bottom
surface, the second protruding member top surface designed to
engage an interior tissue surface of the body when the
deformable second protruding member is reformed to an original
shape;
a diameter of the first protruding member coupled to the
outer surface of the region of the proximal end of the tubular
body and a diameter of the second protruding member coupled
to the outer surface of the region of the distal end of the tubular
body larger than an outer diameter of the tubular body.
App. Br. 9. Independent claim 11 is directed to a method of using a cannula
and recites:
11. A method of inserting a cannula into a tissue, the method
compnsmg:
providing a tubular body having a central axis defined
therethrough and a bore formed therethrough, the body including
axially extendable bellows configured to allow the length of the
body to adjust along the central axis;
piercing an outer tissue layer of the body, forming an
opening in the outer tissue layer of the body;
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Application 13/072,329
deforming a deformable first protruding member and a
deformable second protruding member, wherein the deformable
first protruding member and a deformable second protruding
member are coupled to opposite ends of an outer surface of the
tubular body and a diameter of the first protruding member and
a diameter of the second protruding member are larger than an
outer diameter of the tubular body, the first protruding member
including a first protruding member top surface and a first
protruding member bottom surface, and the second protruding
member including a second protruding member top surface and
a second protruding member bottom surface;
inserting the tubular body into the opening of the outer
tissue layer of the body and into the tissue; and
reforming the deformable first protruding member and a
deformable second protruding member into respective original
shapes such that the first protruding member bottom surface
engages an exterior tissue surface of a body and the second
protruding top surface engages an interior tissue surface of the
body.
Id. at 16-17.
ISSUES AND ANALYSES
We do not adopt the Examiner's conclusion that the claims are
unpatentable as lacking adequate descriptive support. Nor are we persuaded
by the Examiner's conclusion that Appellants' claims are primafacie
obvious over the cited prior art. However, we enter a new ground of
rejection concluding that the claims are prima facie obvious over the
combined cited prior art. We address the arguments raised by Appellants
below.
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Application 13/072,329
A.
Issue
Rejection of claims 1, 6-8, 11, 15, and 19 for lack of written
descriptive support
Appellants argue that the Examiner erred in finding that Appellants'
Specification does not support the idea that the first protruding member is
designed such that its bottom surface engages an exterior tissue surface of
the body when the first protruding member is reformed to its original shape.
App. Br. 7-8.
Analysis
Appellants initially point to paragraph [0017] of their Specification,
which discloses, in relevant part:
As shown, each of the first protruding member 111 and the
second protruding member 121 are coupled to an outer surface
of the tubular body 101 and may be flexible/deformable. Those
having ordinary skill in the art will appreciate that the first
protruding member 111 and the second protruding member 121
may be made of plastic or any material known in the art that may
be deformed, flexed or deflected.... [I]n one or more
embodiments, the first protruding member 111 may be
configured to engage with an exterior tissue surface ... of a body.
Appellants next point to Figure 4 B of their Specification, which is
reproduced below:
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Application 13/072,329
FIG. 4B
Appellants' Figure 4B depicts a side view of an adjustable
cannula that is engaged with a layer of tissue of a body
Appellants argue that the Specification expressly or, alternatively,
implicitly or inherently supports: "the idea that the first protruding member
is designed such that its bottom surface engages an exterior tissue surface of
the body when the first protruding member is reformed to its original shape."
App. Br. 9.
The Examiner responds, with respect to claims 1 and 6-8, that
paragraph [0017] of Appellants' Specification discloses that: (a) the first
protruding member may be deformable; (b) the first protruding member may
be made of a material that may be deformable; and ( c) the first protruding
member may be configured to engage with an exterior tissue surface of a
body. Ans. 8. The Examiner finds that paragraph [0017] does not state that
the first protruding member is designed to engage an exterior tissue surface
of a body when the first protruding member is reformed into its original
shape, as recited in claim 1. Id.
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The Examiner finds that the Specification does not refer to an
"original shape" with respect to the first protruding member, and notes that
the only reference to an "original shape" is with respect to the second
protruding member. Ans. 8 ( citing Spec. ,r 25). Therefore, the Examiner
finds, the Specification does not provide explicit support for the contested
limitation. Id.
The Examiner does not dispute that the first protruding member is
configured to engage with an exterior tissue surface of a body: both
paragraph [0017] and Figure 4B of Appellants' Specification provide
support for such engagement. Ans. 8. However, the Examiner finds, the
Specification does not set forth whether such engagement occurs: (a) when
the first protruding member is in its deformed shape or (b) when the first
protruding member is in its original shape. Id. The Examiner finds that,
because there are two possibilities for when such engagement with the
exterior tissue surface occurs, the Specification does not expressly,
inherently, or implicitly provide support for the contested limitation. Id.
With respect to claims 11, 15, and 19, the Examiner finds that
paragraph [0017] of Appellants' Specification does not recite: (a) the step of
deforming the first protruding member; or (b) the step of reforming the first
protruding member into its original shape such that the first protruding
member bottom surface engages an exterior tissue of a body as recited in
claim 11. Ans. 9--10. The Examiner finds that, although paragraph [0025]
of the Specification expressly recites deforming and reforming the second
protruding member, no such deforming and reforming of the first protruding
member is described as occurring. Id. at 10. The Examiner therefore finds
that, even though the first protruding member may be deformable, the
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Application 13/072,329
Specification does not provide support for performing the steps of deforming
the first protruding member and then reforming the first protruding member
to an original shape. Id.
The Examiner therefore concludes that the claims, as written, lack
adequate written support in the Specification, as required by the first
paragraph of 35 U.S.C. § 112. Ans. 11-12.
With respect to claim 1 and its dependent claims, Appellants reply
that the only issue is whether the Specification expressly, implicitly, or
inherently supports the claims' requirement that, when the first protruding
member engages the exterior tissue, that engagement by the first protruding
member can be in the original shape. Reply Br. 5. Appellants contend that,
given that the protruding members of the cannula, as depicted in Figures 1
and 2 are identical, and given that the second protruding member in Figure
4 B above is in its original shape, the only logical conclusion is that the first
protruding member in Figure 4B is in its original shape when engaged with
the exterior tissue.
With respect to independent claim 11 and its dependent claims,
Appellants argue that, even if deformation of the first protruding member
during insertion is not expressly supported, such a deformation is at least
implicit or inherent. Reply Br. 6. Appellants contend that the inventor
would not have described the first protruding member as deformable if the
inventor did not understand that the first protruding member could be
deformed as part of installation. Id.
We find Appellants' arguments persuasive. Paragraph [0017] of
Appellants' Specification discloses, in relevant part:
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Application 13/072,329
As shown, each of the first protruding member 111 and the
second protruding member 121 are coupled to an outer surface
of the tubular body 101 and may be flexible/deformable. Those
having ordinary skill in the art will appreciate that the first
protruding member 111 and the second protruding member 121
may be made of plastic or any material known in the art that may
be deformed, flexed, or deflected. In one or more embodiments,
a diameter of the first protruding member and/or a diameter of
the second protruding member may be larger than an outer
diameter of the tubular body 101.
Paragraph [0025] of Appellants' Specification discloses that:
Upon insertion into the opening, the second protruding member
of the tubular body of the adjustable cannula may be deformed
such that the tubular body of the adjustable cannula may traverse
through interior tissue of the body to the area of interest within
the body, e.g., a joint. Once the adjustable cannula has been
positioned within the body, the second protruding member of the
tubular body of the adjustable cannula may reform into its
original shape and the top surface of the second protruding
member may engage with an interior tissue surface of the body.
Appellants' Specification thus discloses that both first and second
protruding members are made of deformable or flexible material and that,
during insertion, the second member is deformed and, when reformed to its
original state, engages with the interior tissue surface. We agree with
Appellants that a person of ordinary skill in the art would implicitly
understand that the first protruding member may be similarly deformed
during insertion, and when in contact with the exterior tissue surface, the
protruding member returns to its original, non-deformed state to engage with
the outer tissue surface.
For the same reasons, we agree with Appellants that claim 11 is
supported by the disclosures. Although Appellants' Specification does not
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expressly disclose the step of deforming of the first protruding member, the
claim explicitly describes this step, and the Specification expressly discloses
that both the first and second protruding members are made of deformable
material. See Spec. ,r 1 7. We agree with Appellants that a person of
ordinary skill would understand that the first protruding member, expressly
made of deformable material, could be deformed during the insertion of the
cannula into a body, in a manner similar to the second member and, when
the cannula is inserted, return to its original non-deformed state and engage
the outer tissue surface. We therefore reverse the Examiner's rejection of
the claims on this ground.
B. Rejection of claims 1, and 6-8 as obvious over Golub and Kaji
Issue
The Examiner finds that Golub teaches all of the subject matter of
claim 1 save that the first protruding member is deformable and designed to
engage the exterior tissue surface of the body when it is reformed into its
original shape. Ans. 4---6 ( citing Golub passim). The Examiner finds that
Kaji teaches, inter alia, a cannula comprising a deformable (swelling
member 40 is deformable) and a second protruding member (ring 6) in
which the first protruding member is deformable such that it is inserted in an
uninflated deformed shape and reformed to an original inflated swollen
shape after insertion to allow the tissue (abdominal wall 12) to be
sandwiched between the first and second protruding members and fix the
cannula to the tissue while preventing gas leakage between the tissue and
tubular body. Ans. 6 ( citing Kaji col. 11, 11. 43-50, Fig. 17).
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The Examiner concludes that it would have been obvious to one of
ordinary skill in the art to modify the first protruding member taught by
Golub that it could be deformable such that the first protruding member
bottom surface is designed to engage the exterior tissue surface of the body
when the deformable first protruding member is reformed into an original
shape, as suggested by Kaji, in order to fix the cannula to the tissue while
preventing gas leakage between the tissue and tubular body. Ans. 6.
Appellants point to Figure 17 of Kaji, which is reproduced below:
Figure 17 of Kaji depicts perspective view showing a state in
which the access device for the surgical treatment is attached on
the abdominal wall, the view being accompanied by a cross
section of the access device
Appellants argue that, in Figure 17, the swelling member 40 is
coupled to the flange part 5a defined by a rigid sleeve fixing member (not
numbered in the figure). App. Br. 9 (citing Kaji col. 7, 11. 33--44; col. 11, 11.
44--50). Appellants assert that the swelling member 40 is in a deflated state
during installation (i.e., deflated is the original shape of the swelling member
40 not only as built but also during installation) and, after the device is
inserted through the tissue, the swelling member is inflated with fluid. Id. at
10 (citing Kaji col 11, 11. 33-50). According to Appellants, in this
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embodiment of Kaji, the sectioned part 15 does not appear to be adjustable
along the central axis - the force to provide sealing of the internal features
against the inside of the patient is provided by the dislocation of the swelling
member. Id.
Appellants elaborate that the original shape of Kaji's swelling
member 40, both at construction and during installation, is in the deflated
condition. App. Br. 10-11. According to Appellants, there is no teaching or
suggestion in Kaji that the swelling member 40 could or should be inflated
prior to insertion through tissue. Id. at 11. Appellants assert that only after
the device is inserted through the tissue is the swelling member 40 inflated
with fluid. Id. (citing Kaji col 11, 11. 33-50). Appellants contend that it
logically follows, contrary to the Examiner's findings, that the original shape
of the swollen member 40 is deflated. Id. Furthermore, Appellants argue, a
person of ordinary skill in the art would not have considered a swelling
member 40 inflated with fluid for the first time and after insertion of the
cannula into tissue to be a "reformation" of the swelling member 40 to its
original state. Id. at 12.
Finally, Appellants argue, the sequence of events set forth in the
Examiner's findings, i.e., deflating the Kaji swelling member 40, inserting
the cannula and, finally, re-inflating the swelling member 40 with fluid so
that the cannula is "reformed to an original inflated swollen shape" after
insertion is nontextual, nonsensical, and therefore changes the principle of
operation of Kaji. App. Br. 13 (quoting Final Act. 6).
The Examiner responds that it would have been readily apparent to
one of ordinary skill that swelling member 40, must be fluid-tight to prevent
the escape of fluid into the nearby surgical site. Ans. 12. The Examiner
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finds that it would not be unreasonable to test whether swelling member 40
and swollen member 39 are fluid-tight prior to the first use of the cannula,
and that it would be reasonable for such a test to occur by inflating swelling
member 40. Id. The Examiner finds that this inflated state could therefore
be considered the claimed "original shape," as recited in the claims.
We do not find the Examiner's reasoning persuasive. Kaji teaches,
with respect to Figure 17, that:
On the upper surface and the lower surface of the flange part Sa
on the side outside of the body, a donut-like swollen member is
arranged which member is swollen with a fluid which is injected
with an injection route 42 .... [A]fter the access device is set on
the sectioned part 15, the swelling member 40 on the lower
surface of the flange part Sa is swollen so that the abdominal wall
12 is sandwiched with the removal prevention ring 6 and the
swollen member 40 thereby being fixed to the sectioned part 15
with certitude and, at the same time, serving to prevent the gas
leakage between the sectioned part 15 and the sleeve 3.
Kaji col. 11, 11. 33-51. We find that the most logical interpretation of this
embodiment of Kaji is that the uninflated state of the swelling members is
the "original state" and that, after insertion of the cannula into the tissue, the
swelling members are inflated with fluid via the injection route 42, so as to
hold the cannula more firmly in place. The Examiner speculates that the
apparatus of Kaji may be inflated for testing prior to use and that the inflated
state is, therefore, the "original state." See Ans. 12. But the Examiner's
speculation is without evidentiary support and, absent supporting evidence,
we decline to adopt that line of reasoning. We consequently reverse the
Examiner's rejection of claims 1 and 6-8 on this ground.
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NEW GROUND OF REJECTION
Claim 1 is rejected as unpatentable under 35 U.S.C. § 103(a) as being
obvious over the combination of Golub and Kaji.
Figure 1 of Kaji is reproduced below:
Figure 1 of Kaji depicts a perspective, cross-sectional view of
an embodiment of the present invention attached on an
abdominal wall
With respect to Figure 1, Kaji teaches:
The first valve 1 is fixed to a half solid sleeve fixing member (first
support part) 5 having a flange part Sa, and a side of the sleeve 3
which side is arranged on the outside of the body is fit into the
flange part Sa and is fixed thereto.
A half-solid removal prevention ring ( a second support part) 6
connected to the other end of the sleeve 3 is inserted into the
abdominal cavity thereby serving as a function of preventing the
removal of the sleeve 3 from the abdominal [wall].
Kaji col. 6, 11. 29--47 (emphases added). We find that the half solid sleeve
fixing member 5 of Ka j i's apparatus corresponds to the first protruding
member recited in Appellants' claim 1. Furthermore, we find that a person
of ordinary skill would have understood that the term "half solid" suggests a
material that is flexible or deformable, i.e., semi-solid. We therefore
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conclude that Kaji teaches a: "first protruding member bottom surface
designed to engage an exterior tissue surface of a body when the deformable
first protruding member is reformed into an original shape," as recited in
claim 1. Claim 1 is consequently rejected as being obvious over Golub and
Kaji.
We have entered the new ground only for independent claim 1 and
leave it to the Examiner to evaluate the patentability of claims 6-8 in view
of these references alone or in combination with other newly found or
previously cited references
DECISION
The Examiner's rejection of claims 1, 6-8, 11, 15, and 19 under 35
U.S.C. § 112, first paragraph, is reversed.
The Examiner's rejection of claims 1, and 6-8 under 35 U.S.C.
§ 103(a) is reversed.
We have also entered a new ground of rejection under 37 C.F.R.
§ 4I.50(b) for claim 1.
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b), which provides that "[a] new ground of rejection ...
shall not be considered final for judicial review."
37 C.F.R. § 4I.50(b) also provides that Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new evidence relating to the claims so
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rejected, or both, and have the matter reconsidered by the
examiner, in which event the proceeding will be remanded to the
exammer ....
(2) Request rehearing. Request that the proceeding be reheard
under§ 41.52 by the Board upon the same record ....
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R.
§ 1.136(a)(l)(iv) (2010).
REVERSED
37 C.F.R. § 4I.50(b)
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