Ex Parte Cassivi

Patent Trial and Appeal Board

Jan 19, 2017

13062908 (P.T.A.B. Jan. 19, 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.
230.00560101 8401
EXAMINER
CHENG, JACQUELINE
ART UNIT PAPER NUMBER
3735
MAIL DATE DELIVERY MODE
13/062,908 05/20/2011
26813 7590 01/19/2017
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
Stephen D. Cassivi
01/19/2017 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 PATENT TRIAL AND APPEAL BOARD
Ex parte STEPHEN D. CASSIVI
Appeal 2015-001053
Application 13/062,908
Technology Center 3700
Before JENNIFER D. BAHR, JOHN C. KERINS, and
ARTHUR M. PESLAK, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Stephen D. Cassivi (Appellant) appeals under 35 U.S.C. § 134(a) from
the Examiner’s decision rejecting claims 1, 6—10, 14—23, 25, 27, 28, and
30-34. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
Appeal 2015-001053
Application 13/062,908
THE CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter.
1. A kit for buttressing tissue at an internal body location, the kit
comprising:
one or more sheets of buttress material in a package,
wherein the buttress material is configured for delivery and
attachment to tissue using a stapler;
radioactive material in the package, wherein the
radioactive material is configured for attachment to the one or
more sheets of buttress material; and
carrier material in the package, wherein the carrier
material is separate from the buttress material, and wherein the
radioactive material is provided integrally with the carrier
material.
REJECTIONS
I. Claims 1, 7, 9, 10, and 15 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Prommersberger (US 2009/0001122 Al, pub
Jan. 1, 2009) and Oray (US 2006/0173470 Al, pub. Aug. 3, 2006)
II. Claim 6 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Prommersberger, Oray, and Ostapoff (US 2010/0059570 Al,
pub. Mar. 11, 2010).
III. Claims 8 and 14 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Prommersberger, Oray, and Chan
(US 6,793,798 B2, iss. Sept. 21, 2004).
IV. Claim 8 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Prommersberger, Oray, and Wazer (US 8,267,849 B2, iss.
Sept. 18,2012).
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V. Claims 16—23, 27, 28, 33, and 34 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Prommersberger and Ostapoff.
VI. Claim 25 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Prommersberger, Ostapoff, and Zubik (US 7,377,928 B2, iss.
May 27, 2008).
VII. Claim 30 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Prommersberger, Ostapoff, and Soltz (US 2007/0179528 Al,
pub. Aug. 2, 2007).
VIII. Claims 30 and 31 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Prommersberger, Ostapoff, and Tilton
(US 5,919,184, iss. July 6, 1999).
IX. Claim 32 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Prommersberger, Ostapoff, and Oray.1
DISCUSSION
Claims 1, 6—10, 14, and 15
Claim 1 recites a kit comprising, in a package, one or more sheets of
buttress material, carrier material separate from the buttress material, and
radioactive material provided integrally with the carrier material. Appeal
Br., Claims App. The Examiner finds that Prommersberger discloses one or
more sheets of buttress material (non-porous layer 360) and carrier material
1 The Examiner does not expressly restate Rejections VI—IX in the Answer,
but does state that every ground of rejection set forth in the Final Rejection,
from which the present appeal is taken, “is being maintained . . . except for
the grounds of rejection (if any) listed under the subheading
‘WITHDRAWN REJECTIONS.” Ans. 2. The Answer does not include a
“subheading ‘WITHDRAWN REJECTIONS.’”
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(porous layer 370) separate from the buttress material. Final Act. 3 (citing
Prommersberger H 21, 41—42; Figs. 3A, 3B); see also Ans. 2. With respect
to the limitation that the carrier material is separate from the buttress
material, the Examiner notes that “Prommersberger teaches the non-porous
layer and the porous layer may be connected to one another to form the
multi-layer buttress material and the porous layer may be formed separate
and apart from the non-porous layer.” Final Act. 3 (citing Prommersberger
141 42). According to the Examiner, “under a broadest reasonable
interpretation of ‘separate,’ different or distinct layers of material, such as
the porous and non-porous layers [of Prommersberger’s buttress 350] would
satisfy” the limitation in claims 1 and 10 of carrier material that is separate
from the buttress material. Ans. 4—5 (citing a dictionary definition of
“separate” to establish that “[w]hile separate can mean ‘not joined or
touching physically,’ it can also mean ‘different; distinct’”).
Relying on the description of a kit provided in sealed package 250 set
forth on page 16 of the Specification and the illustration of such a kit in
Figure 3 of the present application, Appellant submits that “a skilled artisan
would understand the feature ‘wherein the carrier material is separate from
the buttress material’ to mean that the carrier materials and the buttress
materials are provided as separate components — not merely that, as the
Examiner suggests, the materials are ‘different or distinct layers of
material.’” Reply Br. 2-4. In particular, Appellant points out that “the
present application explicitly contrasts components ‘provided integrally with
each other’ with ‘separate components.’” Id. at 3 (citing Spec. 16:16—18).
We agree with Appellant. Appellant’s Specification discloses that a
kit according to the invention may include components such as staples,
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buttress material, radioactive material, carrier material, and a medically
useful agent provided in a sealed package and that “two or more of these
components may be provided integrally with each other although they are
depicted as separate components within the kit.” Spec. 16:8—18. Thus,
within the context of the kit, Appellant’s Specification does distinguish, or
contrast, “separate components within the kit” and components “provided
integrally with each other.” Moreover, claim 1 similarly incorporates these
disparate modifiers for the relationship between the carrier material and the
buttress material (i.e., “wherein the carrier material is separate from the
buttress material”) and the relationship between the radioactive material and
the carrier material (i.e., “wherein the radioactive material is provided
integrally with the carrier material”). Accordingly, when viewing the
language of claim 1 within the context of the claim as a whole and in light of
the Specification, a person having ordinary skill in the art would not
consider the porous and non-porous layers of Prommersberger’s buttress 350
to be “separate” from one another as recited in claim 1.
We appreciate that Prommersberger discloses that “[t]he porous layer
may be formed separate and apart from the non-porous layer” and that the
multilayer buttress material may be formed by connecting the non-porous
layer to the porous layer. Prommersberger ^[41—42. Thus, Prommersberger
contemplates that at some point in time after the porous and non-porous
layers have been formed separate and apart from one another and before
they are connected to form the multilayer buttress element, the porous layer
and the non-porous layer exist as physically separate, unattached elements.
However, the Examiner does not point to, nor do we discern, any disclosure
by Prommersberger of providing the physically separate, unattached porous
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layer and non-porous layer in a package as part of a kit, as called for in
claim 1. Relying on teachings in paragraph 33 of Oray, the Examiner
determines that it would have been obvious to provide the buttress and
bioactive agent of Prommersberger in a package. Final Act. 4. However,
the Examiner does not articulate any reason why a person having ordinary
skill in the art would have been prompted to provide the physically separate,
unattached porous layer and non-porous layer in such a package. The
Examiner does not rely on any of Ostapoff, Chan, or Wazer for any teaching
that might overcome this deficiency in the combination of Prommersberger
and Oray. See Final Act. 5—7.
For the above reasons, the Examiner fails to establish by a
preponderance of the evidence that the combination of Prommersberger with
Oray alone or in further combination with Ostapoff, Chan, or Wazer renders
obvious a kit comprising one or more sheets of buttress material and carrier
material separate from the buttress material in a package, as called for in
claim 1. Accordingly, we do not sustain the rejections of claims 1, 6—10,
14, and 15 under 35 U.S.C. § 103(a).
Claims 16—23, 25, 27, 28, and 30—32
In contesting the rejections of these claims (see Final Act. 7—10,
12—16), Appellant argues that “[njothing in Prommersberger paragraphs 41
and 42 teaches or suggests that ‘a carrier element that is separate from a
buttress element’ is provided as part of a surgical fastening device, as
required by claim 16.” Appeal Br. 12.
As discussed above, Appellant’s Specification describes providing
several components, such as carrier and buttress materials, separately (i.e., in
a non-integral manner) from one another in a sealed package to form a kit,
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Application 13/062,908
which can then be used to form a surgical fastening device. Spec. 16:5—22;
Fig. 3. However, in describing the surgical fastening device, Appellant’s
Specification and drawings disclose the carrier material being a portion of or
attached to the buttress material. See, e.g., Spec. 8:24—25; 9:15—16;
12:10—13.2 Thus, the Examiner’s interpretation of a carrier element
“separate” from the buttress element in claim 16 as encompassing “different
or distinct layers of material, such as the porous and non-porous layers” of
Prommersberger’s buttress 350 (Ans. 4—5) is reasonable in light of the
description of the surgical fastening device in Appellant’s Specification.
Moreover, even applying Appellant’s urged construction of “separate”
as excluding layers that are connected to one another (Reply Br. 4) to claim
16, Prommersberger’s disclosure of a porous layer and a non-porous layer
formed separate and apart from one another, prior to being connected to one
another to form a multilayer buttress, satisfies the limitation of “a carrier
element that is separate from the buttress element.” See Prommersberger
41—42; Final Act. 8.
For the above reasons, Appellant’s argument does not apprise us of
error in the Examiner’s rejections of claims 16—23, 25, 27, 28, and 30—32
under 35 U.S.C. § 103(a). Accordingly, we sustain the rejections of these
claims.
Claims 33 and 34
In contesting the rejection of claims 33 and 34, Appellant groups
claims 33 and 34 together. Appeal Br. 13—16. We select claim 33 as
2 Notably, Appellant cites to each of these portions of the Specification as
providing support for the limitation “radioactive material attached to a
carrier element that is separate from the buttress element” in claim 16.
Appeal Br. 5.
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representative of this group, and claim 34 stands or falls with claim 33. See
37C.F.R. §41.37(c)(l)(iv).
Claim 33 is directed to “[a] method [of] buttressing a staple line and
providing radiation therapy” comprising, in pertinent part, “attaching
buttress material to selected tissue using staples” and “attaching radioactive
material to the buttress material by attaching carrier material to the buttress
material using the staples, wherein the radioactive material is integral with
the carrier material.” Appeal Br., Claims App. The Examiner finds that
Prommersberger discloses a method including “‘attaching buttress material
to selected tissue using staples’ and ‘attaching carrier material to the buttress
material using the staples.’” Final Act. 11. The Examiner also finds that
Prommersberger discloses a bioactive agent, which “may be any agent
which provides a therapeutic or prophylactic effect,” combined with either
the buttress material or the carrier material (i.e., the porous layer or the
non-porous layer). Id. (citing Prommersberger | 51). However, the
Examiner acknowledges that “Prommersberger does not teach the bioactive
agent is a radioactive material or provided radiation therapy.” Id.
The Examiner finds that Ostapoff teaches combining radiotherapeutic
agents, such as radioisotopes like iodine 125 and palladium 103, with
buttress material, such as a film, for use in brachytherapy, for example. Id.
at 11—12 (citing Ostapoff H 52, 59, 60). In view of Ostapoff s teachings,
the Examiner determines it would have been obvious “to modify the
bioactive agent combined with the porous layer of Prommersberger to be
radioactive as taught by Ostapoff in order to provide a therapeutic or
prophylactic effect and use the film for brachytherapy.” Id. at 12. Appellant
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does not contest the Examiner’s determination that such a modification
would have been obvious. See Appeal Br. 13—15.
Appellant asserts “that the Examiner provided no explanation as to
why ‘attaching radioactive material to the buttress material by attaching
carrier material to the buttress material using the staples’ as claimed would
have been obvious.” Id. at 13. According to Appellant, ‘“[attaching carrier
material to the buttress material using staples’ — which the Examiner did
address — is not equivalent to ‘attaching radioactive material to the buttress
material by attaching carrier material to the buttress material using the
staples.’” Id. at 14.
In response, the Examiner explains that the porous and non-porous
layers of Prommersberger’s multilayer buttress “are equated to the claimed
buttress material and carrier material” and that Prommersberger’s teaching
of “firing a stapling apparatus to force at least one staple to pass through the
openings on the staple cartridge, at least one multilayer buttress,... the
tissue, and the openings on the staple anvil to seal the tissue” constitutes a
teaching of “attaching buttress material to selected tissue using staples.”
Ans. 5 (citing Prommersberger 119). The Examiner adds that “even though
the carrier material and buttress material are already physically attached as
part of the multi-layer buttress, using staples to attach the multi-layer
buttress to tissue, would be a second means by which the carrier material is
attached to the buttress material using the staples.” Id.
We agree with the Examiner. Notably, claim 33 does not exclude
other means of attachment of the carrier material and/or the radioactive
material to the buttress material in addition to the staples that attach the
buttress material, carrier material, and radioactive material to one another
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and to the selected tissue. In fact, the portions of Appellant’s Specification
cited in the Appeal Brief as providing support for the limitation “attaching
radioactive material to the buttress material by attaching carrier material to
the buttress material using the staples” describe a method in which carrier
elements are attached to the buttress materials prior to stapling. See Appeal
Br. 5 (citing Spec. 10:29-11:2; 14:15—27); Spec. 10:29-32 (describing, “[i]n
some embodiments, the radioactive material may be attached to the buttress
element, either directly or attached via another material (e.g., a carrier
element, etc.) before the buttress element is used as a surgical fastener (e.g.,
before the buttress element is stapled”); Spec. 14:15—17 (describing, in
Figure 1, “a first carrier element 122 is attached to the second layer of
buttress material 120 and a second carrier element 124 is attached to the first
layer of buttress material 118”). When the stapling apparatus is fired to
force staples to pass through at least one multilayer buttress and the tissue,
as disclosed in paragraph 19 of Prommersberger, the steps of attaching
buttress material (e.g., the non-porous layer) to selected tissue using staples
and attaching radioactive material (as the bioactive agent combined with the
porous layer, in view of Ostapoff) to the buttress material by attaching
carrier material (e.g., the porous layer) to the buttress material using the
staples, as called for in claim 33, are performed.
For the above reasons, Appellant fails to apprise us of error in the
rejection of claims 33 and 34 under 35 U.S.C. § 103(a). Accordingly, we
sustain the rejection of claims 33 and 34.
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DECISION
The Examiner’s decision rejecting claims 1, 7, 9, 10, and 15 under
35 U.S.C. § 103(a) as unpatentable over Prommersberger and Oray is
REVERSED.
The Examiner’s decision rejecting claim 6 under 35 U.S.C. § 103(a)
as unpatentable over Prommersberger, Oray, and Ostapoff is REVERSED.
The Examiner’s decision rejecting claims 8 and 14 under 35 U.S.C.
§ 103(a) as unpatentable over Prommersberger, Oray, and Chan is
REVERSED.
The Examiner’s decision rejecting claim 8 under 35 U.S.C. § 103(a)
as unpatentable over Prommersberger, Oray, and Wazer is REVERSED.
The Examiner’s decision rejecting claims 16—23, 27, 28, 33, and 34
under 35 U.S.C. § 103(a) as unpatentable over Prommersberger and
Ostapoff is AFFIRMED.
The Examiner’s decision rejecting claim 25 under 35 U.S.C. § 103(a)
as unpatentable over Prommersberger, Ostapoff, and Zubik is AFFIRMED.
The Examiner’s decision rejecting claim 30 under 35 U.S.C. § 103(a)
as unpatentable over Prommersberger, Ostapoff, and Soltz is AFFIRMED.
The Examiner’s decision rejecting claims 30 and 31 under 35 U.S.C.
§ 103(a) as unpatentable over Prommersberger, Ostapoff, and Tilton is
AFFIRMED.
The Examiner’s decision rejecting claim 32 under 35 U.S.C. § 103(a)
as unpatentable over Prommersberger, Ostapoff, and Oray is AFFIRMED.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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