Ex Parte Sargeant et al

Patent Trial and Appeal Board

Jun 9, 2017

12897011 (P.T.A.B. Jun. 9, 2017)

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.
12/897,011 10/04/2010 Timothy Sargeant H-US-02118 (203-7145) 1038
50855 7590
Covidien LP
60 Middletown Avenue
c/o Legal - Mailstop MS 54
North Haven, CT 06473
06/13/2017 EXAMINER
LYNCH, ROBERT A
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
06/13/2017 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):
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
mail @ cdfslaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TIMOTHY SARGEANT, JOSHUA STOPEK,
MICHAEL BETTUCHI, ARP AN DESAI, ATU AGAWU, and
SAUMYA BANERJEE1
Appeal 2016-002294
Application 12/897,011
Technology Center 3700
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
DAVID COTTA, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellants state the real party-in-interest is Covidien LP. App. Br. 2.
Appeal 2016-002294
Application 12/897,011
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 25 40 and 42-47.2 Specifically,
claims 25—30, 33—36, 39, 40, 42-45 and 47 stand rejected as unpatentable
under 35 U.S.C. § 102(b) as being anticipated by King et al. (US 3,874,388,
April 1, 1975, 2006) (“King”).
Claims 25, 33, 45, and 46 also stand rejected as unpatentable under 35
U.S.C. § 102(b) as being anticipated by Tomkinson. (US 1,805,319, May 13,
1931) (“Tomkinson”).
Claims 31, 32, 37 and 38 stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over the combination of King and
Milbocker (US 2002/0049503 Al, April 25, 2002) (“Milbocker”).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
NATURE OF THE CFAIMED INVENTION
Appellants’ invention is directed to a biocompatible wound closure
devices including an elongate body and a plug member useful for wound
repair. Abstract.
REPRESENTATIVE CLAIM
Claim 25 is representative of the claims on appeal and recites:
25. A wound closure device comprising:
2 Claims 1—24 and 41 are canceled. App. Br. 15, 17.
2
Appeal 2016-002294
Application 12/897,011
an elongate body that extends longitudinally between a
proximal end and a distal end, the elongate body having a pair of
planar side surfaces;
a plug member including a first section and a second
section, each of the first and second sections being hingedly and
directly connected to one of the pair of planar side surfaces of the
elongate body, the first and second sections being independently
movable relative to one another, the first and second sections
being movable between a deployed position in which the first
and second sections extend at a predetermined angle relative to
the elongate body, and a collapsed position in which the first and
second sections extend at an angle relative to the elongate body,
the angle being less than the predetermined angle of the deployed
position; and
a stop member at the distal end of the elongate body
configured to prevent the first and second sections of the plug
member from extending beyond the predetermined angle of the
deployed position.
App. Br. 15.
A, Claims 25-30. 33-36. 39. 40. 42-A5 and 47 under 35 U.S.C. $1020?)
over King
Issue
Appellants argue the Examiner erred in finding that King teaches or
suggests the limitation of claim 25 reciting “a plug member including a first
section and a second section, each of the first and second sections being
hingedly and directly connected to one of the pair of planar side surfaces of
the elongate body.” App. Br. 7.
3
Appeal 2016-002294
Application 12/897,011
Analysis
The Examiner finds King discloses (see Figs. 2A-2C, 9A-9E and 11) a
cardiac septal defect closure system comprising an elongate body/central
hub that extends longitudinally between a proximal end and a distal end, the
elongated body having a pair of planar side surfaces. Final Act. 6 (citing
King Figs. 2A-C, 11, col. 7,11. 16—20). Specifically, the Examiner finds the
planar side walls of grooves 89 are disposed within the sidewall of the hub
84 into which the respective upper and lower struts 81 may recess. Id.
The Examiner finds that King further discloses a plug member,
including a substantially identical first section (upper strut 81) and a second
section (lower strut 81), the first and second sections (81) being hingedly
connected (via respective hinge holes 86') to one of the pair of planar side
surfaces of the elongate body. Id. (citing King Figs. 2A-B, 11). The
Examiner finds the upper and lowers struts 81 are hingedly connected to the
planar side surfaces of the respective grooves 89 within the sidewall of the
hub 84 as the struts 81 move between their collapsed and deployed positions.
Id. The Examiner finds the grooves 89 are defined by planar side surfaces
within the sidewall of the hub 84 and the first and second sections 81 are
hingedly connected thereto at hinge connection holes 86' to retain and
pivotally connect the respective first and second sections 81 within and
directly against/to the respective planar side surfaces/walls of the respective
grooves 89 for delivery and deployment. Id.
Appellants argue King is directed to a closure apparatus including a
hub 84 that has surfaces that are grooved 89 to allow struts 81 to “lie
superficially in their surfaces without adding to the exterior bulk of the
umbrella-like structures [such that] the struts 81 [ ] are movably attached to
4
Appeal 2016-002294
Application 12/897,011
the hub 84 ... by hinge ring element [ ] 86.” App. Br. 7 (quoting King col.
6,11. 37-41).
Appellants point out that the Examiner finds that King’s hub 84
corresponds to the “elongated body” recited in claim 25. App. Br. 8.
Appellants contend that the hub 84 has an annular/circular body, and it is
therefore unclear how the hub 84 could be characterized as having planar
side surfaces. Id. (King Fig. 2C). Appellants assert King’s struts 81 are
attached to the hub 84 by ring element 86, which is supported within an
annular groove having an arcuate cross-section, so that the struts 81 can be
positioned within the spaces defined by grooves 89. Id. (citing King Figs.
2B-2C).
Appellants contend that, even if the struts 81 are positioned within a
space defined within the annular outer surface of King’s hub 84, which the
Examiner asserts is a planar side surface, a person of ordinary skill in the art
would have understood that such positioning does not amount to contact
with the surfaces that define the space, let alone a direct connection thereto.
App. Br. 9. Rather, Appellants argue, the only connection of struts taught by
King is with respect to ring element 86, and not with respect to those
surfaces that define the space within which struts 81 are positioned. Id.
Therefore, Appellants argue, a person of ordinary skill in the art
would not have understood the struts 81 of King to be connected to any
planar side surface, much less hingedly and directly connected thereto, as
recited in independent claim 25. Id.
The Examiner responds that King discloses that the grooves 89 are
defined by planar side surfaces disposed in and as part of the sidewall of the
hub 84. Ans. 3 (citing King Fig. 2C). The Examiner finds the first and
5
Appeal 2016-002294
Application 12/897,011
second sections of the stmts 81 are hingedly connected to the hub 84 at
hinge connection holes 86' to retain and pivotally connect the respective first
and second sections 81 within and directly against/to the respective planar
side surfaces/walls of the respective grooves 89 between delivery and
deployment configurations. Id. The Examiner finds the grooves 89 defined
by the planar walls are part of the side wall perimeter of the hub 84 and that
the hinge ring 86 pivotally holds the stmts/sections 81 directly against the
planar side walls of the grooves 89. Id. (citing King Fig. 2B-C).
We are not persuaded by the Examiner’s findings and conclusion.
Figures 2B-C of King are reproduced below:
Figures 2B-C of King are side cross-sectional and end views,
respectively, of the inner, central hub of the disclosed umbrella­
like closure element
It is the Examiner’s position that the walls and/or the floor of the
grooves 89, into which the stmts 81 are hinged and articulate, constitute the
“pair of planar side surfaces” of the elongate body against which the first
6
Appeal 2016-002294
Application 12/897,011
and second sections (i.e., the stmts 81) are “hingedly and directly
connected,” as required by claim 25. We are not persuaded that King
discloses that the walls and/or floor of the grooves are indeed planar.
King discloses:
The stmts 81, 91 are attached to the umbrella-like closure
elements 8, 9 through a central huh 84 and a sliding sleeve 94,
respectively, made of for example stainless steel. The surfaces of
the hub 84 and the sleeve 94 are grooved (note FIGS. 2C and 3C)
in such a manner to allow the stmts 81, 91, respectively, to lie
superficially in their surfaces without adding to the exterior bulk
of the umbrella-like stmctures. The stmts 81, 91 are movably
attached to the hub 84 and sleeve 94 by hinge ring elements 86,
96, respectively, and there are included ring-like stmt keepers 87,
97, respectively, to prevent the stmts 81, 91 from opening,
respectively, beyond 90°. Each umbrella-like clement 8, 9 is of
small enough size to allow it to he placed within the outer, thin
wall catheter 1 within which it is transported during application,
as described more fully below.
King col. 6,11. 32-48. King further discloses that: “To [sic] total external
diameter of the hub 84 is for example 3.3 mm, and it has been engineered
with grooves 89 so that the stmts 81 are recessed within the surface and do
not occupy any additional space within the outer catheter 1.” Id. at col. 7,11.
16—20. But the Examiner does not point to, nor can we discern, any
disclosure of King that expressly states or requires that the walls or the floor
of the grooves 89 are planar.
Because King fails to expressly disclose all of the limitations of claim
25, we reverse the Examiner’s rejection of the claims.3
3 We are mindful of our reviewing court’s holding that: “[A] reference can
anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitation
7
Appeal 2016-002294
Application 12/897,011
B. Rejection of claims 25, 33, 45, and 46 under 35 U.S.C. $ 102(b) over
Tomkinson
Issue
Appellants argue the Examiner erred because the language in the
preamble of the claims limits the claims, and define an element of the claim
not disclosed by Tomkinson. App. Br. 10.
Analysis
The Examiner finds Tomkinson discloses all of the limitations of the
claims. Final Act. 8—10. Tomkinson is directed to: “[TJoggle bolts, such as
are used for securing articles to walls or ceilings of brick, stone or
cementitious material not adapted to directly receive a threaded member.”
Tomkinson col. 1,11. 1—5.
Appellants argue that the claims require, inter alia, a “wound closure”
device and, further, that claim 45 requires a “wound closure device for
repairing and sealing a perforation in tissue at a laparoscopic port site of the
tissue.” App. Br. 10. Appellants contend that toggle bolts of Tomkinson
have nothing to do with wound closure. Id.
arranged or combined as in the claim, if a person of skill in the art, reading
the reference, would ‘at once envisage’ the claimed arrangement or
combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d
1376, 1381 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681
(C.C.P.A. 1962)). However, we do not find that the disclosures of King are
such that a person of ordinary skill in the art would immediately realize that
the grooves disclosed by King necessarily disclose “first and second sections
being hingedly and directly connected to one of the pair of planar side
surfaces of the elongate body,” as recited in claim 25.
8
Appeal 2016-002294
Application 12/897,011
Appellants point to Kropa v. Robie, 187 F.2d 150, 152 (C.C.P.A.
1951), in which the predecessor to our reviewing court held that a preamble
reciting “[a]n abrasive article” was deemed essential to point out the
invention defined by claims. App. Br. 11. Appellants note that the court
held that “it is only by that phrase that it can be known that the subject
matter defined by the claims is comprised as an abrasive article. Every
union of substances capable inter alia of use as abrasive grains and a binder
is not an ‘abrasive article.’” Id. (quoting Kropa, 187 F.2d at 152).
According to Appellants, the instant appeal parallels the factual
situation of Kropa; i.e., Appellants contend that not every closure device is
relevant to “wound closure” devices or a “wound closure device for
repairing and sealing a perforation in tissue at a laparoscopic port site of the
tissue.” App. Br. 11. Therefore, Appellants argue, the features recited in at
least the preamble of the claims should be “construed as if in the balance of
the claim.” Id.
Furthermore, argue Appellants, claims 33 and 45 include features
cited in the body of the claims that further provide distinguishing context.
By way of example, Appellants point to the language of claim 33, which
recites: “[A] plug member including a tissue facing surface ... the tissue
facing surface” as providing distinguishing context “necessary to give life,
meaning, and vitality” to the “wound closure device” recited in the
preamble. Id. (quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d
1298, 1305 (Fed. Cir. 1999)).
Similarly, Appellants argue, the body of claim 45 recites “the elongate
body being adapted to be secured within the perforation at the laparoscopic
port site; a plug member adapted to be secured to the tissue at the
9
Appeal 2016-002294
Application 12/897,011
laparoscopic port site adjacent to the perforation ... the plug member in the
deployed position adjacent to the laparoscopic port site to enable repair and
sealing of the perforation at the laparoscopic port site.” App. Br. 18—19.
Appellants therefore contend that, given that the preamble of independent
claim 45 provides an antecedent basis for limitations recited in the body of
claim 45, the preamble of claim 45 should be construed as of independent
claim 45. Id. at 12 (citing Pacing Technologies, LLC v. Garmin
International, Inc., 778 F.3d 1021, 1024 (Fed. Cir. 2015) (holding that the
preamble was deemed limiting because it provided antecedent basis for
terms appearing in the body of the claim).
The Examiner responds that the term “wound” in the preamble has not
been given patentable weight because the term occurs in the preamble and
fails to add any additional structural elements to the device. Ans. 4. The
Examiner states that a preamble is generally not accorded patentable weight
where it merely recites the purpose of a process or the intended use of a
structure, and where the body of the claim does not depend on the preamble
for completeness but, instead, the process steps or structural limitations are
able to stand alone. Id. (citing, e.g., See MPEP § 2111.02
The Examiner finds that, for these claims, the preamble fails to add
any additional structural limitations to the claims: all of the structural
limitations of the device claims are expressly set forth within the body of the
claims. Ans. 4. The Examiner finds the preamble recites merely an
intended use of the structure and the structural limitations found in the claim
body are able to stand alone. Id. at 4—5.
The Examiner finds Appellants’ reliance Kropa to be inapposite.
App. Br. 5. The Examiner notes that Kropa concerned a distinct structural
10
Appeal 2016-002294
Application 12/897,011
characteristic or feature of the device as claimed found within the preamble
(i.e., an abrasive article), whereas the Examiner finds the preamble of
Appellants’ claim is merely a preferred or intended use and/or functional
language statement without any reference to an additional structural feature
of the device claim. Id. The Examiner finds the preambles to Appellants’
claims fail to result in a structural difference over the prior art, and thee prior
art device is fully capable of performing such an intended use/function if one
so desires (i.e., the device of Tomkinson is at least fully capable of sealing a
cylindrical puncture site having a diameter smaller than the diameter of the
shaft of the Tomkinson device). Id.
With the exception of claim 45, we agree with the Examiner. The
determination of whether a preamble limits a claim is made on a case-by-
case basis in light of the facts in each case; there is no litmus test defining
when a preamble limits the scope of a claim. Catalina Mktg. Int 7 v.
Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).
Appellants do not argue that Tomkinson fails to disclose all of the
structural limitations of claims 25, 33, and 46. Rather, Appellants argue that
the preamble should be given patentable weight because it distinguishes the
intended use of their claimed invention (a wound closure device) from that
of the prior art (a toggle bolt used for securing articles to walls or ceilings);
two unrelated functions. See App. Br. 10. And it is true that clear reliance
on the preamble during prosecution to distinguish the claimed invention
from the prior art may transform the preamble into a claim limitation
because such reliance indicates use of the preamble to define, in part, the
claimed invention. Catalina, 289 F.3d at 808-09 (citing Bristol-Myers
Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir. 2001) (A
11
Appeal 2016-002294
Application 12/897,011
preamble may limit when employed to distinguish a new use of a prior art
apparatus or process)). However, preambles describing the use of an
invention generally do not limit the claims, because the patentability of
apparatus or composition claims depends on the claimed structure, and not
on the use or purpose of that structure. Id. at 809 (citing In re Gardiner, 171
F.2d 313, 315-16 (C.C.P.A. 1948); see also Catalina, 289 F.3d 809-10
(examples).
It is indisputable that Appellants’ preamble proposes a new intended
use (wound closure) for the toggle bolt device disclosed by Tomkinson, and
it is further not disputed that the latter discloses all of the structural
limitations of Appellants’ claims but does not contemplate such an intended
use. However, Appellants’ claims 25, 33, and 46 do not claim a method of
using the claimed device in closing a wound, but rather claim the device
itself (i.e., they are machine claims), and Appellants do not dispute that their
claimed device is structurally disclosed in its entirety by the cited prior art.
As such, we do not accord the preamble patentable weight. In other words,
although a preamble reciting a new intended use for Tomkinson’s toggle bolt
in a claim for a method for closing wounds might be accorded patentable
weight, when used in a claim for the device itself, as disclosed by
Tomkinson, it is not so accorded. We consequently affirm the Examiner’s
rejection of claims 25, 33, and 46.
However, we agree with Appellants’ reasoning with respect to claim
45. The body of claim 45 recites, in relevant portions, “the elongate body
being adapted to be secured within the perforation at the laparoscopic port
site” and “a plug member adapted to be secured to the tissue at the
laparoscopic port site adjacent to the perforation” and “the stop member
12
Appeal 2016-002294
Application 12/897,011
adapted to support the plug member in the deployed position adjacent to the
laparoscopic port site to enable repair and sealing of the perforation at the
laparoscopic port site.” Not only is Tomkinson silent with respect to
laparoscopy and its attendant port sites and tissues, these limitations reflect
back directly upon, and are defined by, the preamble’s recitation of: “A
wound closure device for repairing and sealing a perforation in tissue at a
laparoscopic port site of the tissue.” We agree, therefore, with the Examiner
that the language of the preamble recites an antecedent basis for the
remaining language of the body of the claim. As such, we accord, in this
instance, the preamble patentable weight. See Catalina, 289 F.3d at 808
(“[Dependence on a particular disputed preamble phrase for antecedent
basis may limit claim scope because it indicates a reliance on both the
preamble and claim body to define the claimed invention.” (citing Bell
Commc’ns Research, Inc. v. Vitalink Commc’ns Corp., 55 F.3d 615, 620
(Fed. Cir. 1995) (“[W]hen the claim drafter chooses to use both the
preamble and the body to define the subject matter of the claimed invention,
the invention so defined, and not some other, is the one the patent
protects”))).
Because we find that the preamble establishes antecedent basis that
defines the subject matter, we find the preamble limits the claim, and we
consequently reverse the Examiner’s rejection of claim 45.
13
Appeal 2016-002294
Application 12/897,011
C. Rejection of claims 31, 32, 37 and 38 under 35 U.S.C. $ 103(a) over
King and Milbocker
Issue
Appellants argue the Examiner’s citation of Milbocker fails to cure
the alleged deficiencies of King with respect to claims 25 and 33. App. Br.
13.
Analysis
Claim 31 is representative of these dependent claims and recites: “The
wound closure device of claim 25, wherein the elongate body, the plug
member, or both, includes at least one reactive group that bonds to tissue.”
App. Br. 16.
The Examiner relies upon Milbocker as teaching a system for
repairing tissue defects comprising a plug member comprising a mesh and at
least one reactive group/cyanoacrylate adhesive. Final Act. 11 (citing
Milbocker claim 4, Abstr., || 49, 50, 73, 32, 48, 70). The Examiner finds
the reactive group bonds to tissue in order to adhere and secure the plug and
mesh to the surrounding tissue treatment site without the need for sutures or
other fixing devices thereby lessening the incidence of extreme traction at
isolated points. Id. (citing Milbocker 32, 39, 48, 73, 74]).
The Examiner therefore concludes it would have been obvious to one
having ordinary skill in the art at the time the invention was made to modify
the plug member of King to further comprise a mesh and at least one
reactive group that bonds to tissue in order to adhere and secure the plug and
mesh to the surrounding tissue treatment site without the need for sutures or
other fixing devices. Final Act. 11—12.
14
Appeal 2016-002294
Application 12/897,011
Appellants contend Milbocker was cited only as having taught a
system for repairing tissue defects using a plug member including a mesh
and at least one reactive group that bonds to tissue. App. Br. 13. Appellant
contends that King and Milbocker, either alone or in any proper
combination, do not render claims 25 or 33 obvious, or claims 31, 32, 37 and
38, which depend from them. Id.
The Examiner repeats the finding that that King discloses each and
every element of independent claims 25 and 33. Therefore, the Examiner
finds, King has no deficiencies of disclosure to be cured and Milbocker is
properly cited to teach the obviousness of claims 31, 32, 37 and 38.
As we have explained supra, we are not persuaded by the Examiner
that King discloses each and every limitation of independent claims 25 and
33. We consequently reverse the Examiner’s rejection of claims 31, 32, 37
and 38.
DECISION
The Examiner’s rejection of claims 25, 33, and 46 as unpatentable
under 35 U.S.C. § 102(b) is affirmed.
The Examiner’s rejection of claims 26—30, 34—36, 39, 40, 42-45 and
47 as unpatentable under 35 U.S.C. § 102(b) is reversed.
The Examiner’s rejection of claims 31, 32, 37 and 38 as unpatentable
under 35 U.S.C. § 103(a) is reversed.
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). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED-IN-PART
15