Ex Parte Dubrul et al

Board of Patent Appeals and Interferences

Jun 22, 2012

10463026 (B.P.A.I. Jun. 22, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
10/463,026 06/17/2003 William R. Dubrul DEV-5431USCNT7 9713
21884 7590 06/22/2012
WELSH FLAXMAN & GITLER LLC
2000 DUKE STREET, SUITE 100
ALEXANDRIA, VA 22314
EXAMINER
TOWA, RENE T
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
06/22/2012 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 WILLIAM R. DUBRUL, RICHARD E. FULTON
and ROBERT M. CURTIS
__________

Appeal 2011-001425
Application 10/463,026
Technology Center 3700
__________

Before LORA M. GREEN, FRANCISCO C. PRATS, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
method for obtaining a tissue, such as a tumor, from a target site of a patient.
The Examiner has rejected the claims as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.

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STATEMENT OF THE CASE
The Specification describes a method for removing a target tissue,
such as a diseased or tumor tissue, from a target site in the body, which
leaves a void at the target site in the body. (Spec. [0010].) The method
involves using a tissue removal device (id. at [0018]), as well as introducing
and expanding an expandable element inside the void (id. at [0010]). The
method may include using a sheath, which is “maintained at least part way,
and preferably completely, along the passageway from the region external of
the patient to the void at the target site.” (Id. at [0012].) Upon removal of
the tissue “in a substantially intact form,” a health care professional may
“inspect the outer surface of the layer of tissue for evidence of the target
tissue” (id. at [0010]), and determine “whether all of the target tissue at the
target site was removed” (id. at [0011]). If one determines that the
procedure has not removed all of the target tissue, one option is to repeat the
procedure. [Id. at [0053].)
Claims 3, 5-7, 9-12, 15, and 18-25 are on appeal. Independent claim
22 is representative, and reads as follows (emphasis added):
22. A method for obtaining tissue from a target site of a patient
comprising:
choosing a tissue removal device of a first size;
inserting a sheath between an access site and target tissue site;
removing target tissue from a target site using the tissue
removal device of a first size inserted through the sheath to create a
void at the target site;
inspecting an outer surface of the removed target tissue for
evidence of diseased tissue to determine whether adequate target
tissue at the target site was removed;
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introducing an expandable element into the void at a target site
through the sheath;
expanding the expandable element to at least substantially fill
the void, thereby forming an expanded element in the void;
selecting a tissue removal device of a second size;
removing additional tissue in the form of a layer of tissue that at
least partially surrounds the expanded element with the tissue removal
device of a second size; and inspecting an outer surface of the
removed layer of additional tissue for evidence of diseased tissue.
The claims stand rejected as follows:
(I) Claims 3, 5-7, 9-12, 15, and 22-24 under 35 U.S.C. § 103(a) as
obvious over Carroll (U.S. Patent No. 6,375,634 B1, issued Apr. 23, 2002)
in view of Eggers et al. (U.S. Patent No. 6,277,083 B1, issued Aug. 21,
2001) and Topel et al. (U.S. Patent No. 5,488,958, issued Feb. 6, 1996) and
further in view of Rada (U.S. Patent No. 5,829,256, issued Nov. 3, 1998).
(II) Claims 18-21 under 35 U.S.C. § 103(a) as obvious over Carroll in
view of Eggers, Topel, and Rada, and further in view of Chin et al. (U.S.
Patent No. 5,928,260, issued Jul. 27, 1999 ).
(III) Claim 25 under 35 U.S.C. § 103(a) as obvious over Carroll in
view of Eggers, Topel, and Rada, and further in view of Janzen et al. (U.S.
Patent No. 5,922,024, issued Jul. 13, 1999 ).
Claim 22 is the only independent claim on appeal. As noted by
Appellants, the “remaining claims are not argued separately” (App. Br. 5).
Issues
Does the Examiner establish that claim 22 is obvious over Carroll in
view of Eggers, Topel, and Rada, and specifically, does the Examiner
present a rationale as to why one would have altered Carroll’s method in
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view of Rada to include a step of “inspecting an outer surface of the
removed target tissue for evidence of diseased tissue to determine whether
adequate target tissue at the target site was removed” as recited in claim 22?
Principles of Law
The Examiner bears the initial burden, on review of the prior art or on
any other ground, of presenting a prima facie case of unpatentability. In re
Oetiker, 977 F.2d 1443, 1445 (1992). If the Examiner meets that initial
burden, the burden of coming forward with evidence or argument shifts to
the applicant. In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). After the
applicant submits such evidence or argument, the PTO then determines
patentability “on the totality of the record, by a preponderance of evidence
with due consideration to persuasiveness of argument.” Oetiker, 977 F.2d at
1445.
Analysis
Claim 22 recites a method comprising the step of “inspecting an outer
surface of the removed target tissue for evidence of diseased tissue to
determine whether adequate target tissue at the target site was removed.”
Appellants argue that Carroll fails to disclose this element. (App. Br. 7.)
Appellants contend that Carroll teaches removal of a target tissue via a
capsule that surrounds the removed tissue, and therefore Carroll is “unable
to inspect the outer surface of the tissue removed.” (Id. at 8.) In addition,
although Appellants acknowledge that “Carroll does evacuate the capsule,”
i.e., remove the target tissue from the capsule, Appellants argue that “the
evacuation is done by ‘recessed rotation or reciprocating sharp blades with
vacuum assisted entry of tumor into blade proximity’.” (Id.; see also
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Carroll, col. 4, ll. 22-27.) According to Appellants, therefore, the “tumor
will be sliced and diced, and sucked out of the capsule,” and “there will be
no outer surface to inspect.” (Id. at 8-9.)
Appellants also assert that none of the other cited references “remedy
this deficiency as it would be impossible to do so without substantially
altering the invention of Carroll.” (Id. at 9.) Specifically, Appellants argue
that “[w]hile Rada does teach inspecting the outer surface of removed target
tissue, there is no rationale provided as to why Rada would be used to alter
the method of Carroll.” (Id.)
The Examiner finds that Carroll discloses all elements recited in claim
22, except that “Carroll is silent about [1] the size of the tissue removal
devices during the removal steps” and “fails to explicitly teach [2] a sheath
or [3] a step of inspecting the outer surface of the removed target tissue for
evidence of diseased tissue to determine whether adequate target tissue at the
target site was removed.” (Ans. 7 (bracketing numbering added).) The
Examiner finds that Eggers, Topel and/or Rada describe these elements, and
concludes that it would have been obvious to modify the method of Carroll
to include these aspects. (Id. at 7-10.) Appellants do not dispute the
findings on which the Examiner’s obviousness conclusion is based, except
regarding [3], i.e., the “inspecting” step, as discussed above. (Id. at 14.)
Regarding the “inspecting” step, the Examiner notes that Carroll
teaches a method wherein, inter alia, “the cutting blades 10 can cut a fresh
cavity outside of the capsule, freeing the capsule from external tissue
attachment, allowing easy intact capsule extraction (see col. 4, lines 38-41).”
(Ans. 4.) Specifically, Carroll describes “(g) Removing the capsule from the
patient,” and teaches that removal “can be accomplished in several
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alternative ways.” (Carroll, col. 4, ll. 33-47.) The alternative ways include
where “(ii) Insertion of a sterile disposable sharp blade array can cut a fresh
cavity along the outside of the capsule, freeing the capsule from external
tissue attachment, allowing easy intact capsule extraction.” (Id. at ll. 38-41
(emphasis added); see also Ans. 15.)
As also noted by the Examiner, Rada “teaches that it is known to
inspect an outer surface or margin of a removed target tissue for evidence of
diseased tissue to determine whether adequate target tissue at the target site
was removed (see col. 1, lines 15-26 & 41-62).” (Ans. 8.) Specifically,
Rada discloses that it is “important during such surgical procedures to ensure
that all cancerous growth associated with a tumor has been removed.”
(Rada, col. 1, ll. 15-17.) Rada explains that “[f]or this purpose the exterior
or margins of the excised tissue are studied microscopically to ensure that
they are clear of cancerous tissue.” (Id. at ll. 17-19.) Rada discusses how “if
microscopic study of the margins of the removed tissue demonstrate that
cancer has grown outside of the excised tissue, then the doctor must return to
the patient and remove a subsequent additional tissue specimen.” (Id. at ll.
51-57.) As taught by Rada, “[t]his subsequent specimen is then tested in the
same manner as the first and this process is continued until the specimen
proves to be clear of cancerous tissue.” (Id. at ll. 57-60.)
We agree with the Examiner that if one cuts “ʻa fresh cavity along the
outside of the capsule’” as taught in Carroll (Carroll, col. 4, ll 39-49), this
action would necessarily involve “cutting of a fresh layer of tissue along the
outside surface of the capsule.” (Ans. 15.) Because Rada taught and
provided motivation for inspecting “the exterior or margins of the excised
tissue” (Rada, col. 1, ll. 17-19), one would have been motivated to inspect
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“the fresh layer of tissue hence removed during removal of the capsule as
taught by Carroll,” i.e., inspect the outer surface of the removed target tissue
containing the capsule therein, “in order to ensure that the margins or
exterior of the target tissue are clear from cancerous tissue.” (Ans. 15-16.)
Appellants’ arguments do not address the teachings in Carroll to
remove a capsule by cutting “cut a fresh cavity along the outside of the
capsule” in the body (Carroll, col. 4, ll. 38-41). Rather, Appellants assert
that one could not inspect the outer surface of a removed target tissue using
Carroll’s method because the target tissue would be located inside the
capsule and then “sliced and diced” during removal from the capsule. (App.
Br. 8-9.) Even assuming we agree with this assessment, Appellants do not
address the situation, disclosed in Carroll, where an outer surface of the
removed target tissue is present on the outside of a capsule after the capsule
is removed by one of the “alternative ways” described in Carroll. Thus,
Appellants do not persuade us that the Examiner has failed to present a case
of obviousness of claim 22.
Conclusion of Law
We conclude that the Examiner establishes that claim 22 is obvious
over Carroll in view of Eggers, Topel, and Rada. Based on the teachings in
Rada, the Examiner presents a rationale as to why one would have altered
Carroll’s method in view of Rada to include the step of “inspecting an outer
surface of the removed target tissue for evidence of diseased tissue to
determine whether adequate target tissue at the target site was removed.”
As they were not argued separately (see App. Br. 5), claims 3, 5-7, 9-12, 15,
23, and 24 fall with claim 22. See 37 C.F.R. § 41.37(c)(1)(vii ).

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SUMMARY
We affirm the obviousness rejection of claims 3, 5-7, 9-12, 15, and
22-24 over Carroll in view of Eggers and Topel, and further in view of Rada.
Because Appellants do not argue the other appealed rejections separately,
and because we detect no deficiency in the Examiner’s conclusion of
obviousness as to those rejections, we affirm the rejection of dependent
claims 18-21 as obvious over Carroll in view of Eggers, Topel, and Rada,
and further in view of Chin, as well as the rejection of dependent claim 25 as
obvious over Carroll in view of Eggers, Topel, and Rada, and further in view
of Janzen.

TIME PERIOD FOR RESPONSE
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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