Ex Parte Piskun

Patent Trial and Appeal Board

Oct 18, 2018

14214898 (P.T.A.B. Oct. 18, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/214,898 03/15/2014
50855 7590
Covidien LP
60 Middletown A venue
Mailstop 54, Legal Dept.
North Haven, CT 06473
10/22/2018
FIRST NAMED INVENTOR
Gregory Piskun
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.
H-ET-01US6(203-10276CIPDI 9521
EXAMINER
KASZTEJNA, MATTHEW JOHN
ART UNIT PAPER NUMBER
3795
NOTIFICATION DATE DELIVERY MODE
10/22/2018 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):
rs. patents. two@medtronic.com
mail@cdfslaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GREGORY PISKUN 1
Appeal2017---009595
Application 14/214,898
Technology Center 3700
Before ERIC B. GRIMES, TA WEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a surgical
method, which have been rejected as obvious and indefinite. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The invention relates to "a hemorrhoid treatment method wherein the
base of a hemorrhoid is compressed by jaws of a clamping instrument, and
then the vascular supply of the hemorrhoid is occluded by application of an
1 Appellant identifies the Real Party in Interest as Covidien LP. Br. 1.
Appeal2017---009595
Application 14/214,898
impact or energy." Spec. 1: 11-13. The method uses an instrument assembly
comprising two components: a hollow body member and a tissue occlusion
component. Id. at 14:18-19, 16:8-9. 2 The hollow body member has a
sidewall with a window, and optionally a shutter that opens and closes the
window. Id. at 14:21-22, 15:1-3.
The tissue occlusion component comprises a pair of jaws that can be
clamped together and a mechanism for coupling tissue gripped between the
jaws. 16:8-14, 20-21. The coupling mechanism can be, for example, a
stapling mechanism, a mechanism for injecting a sclerosing composition, a
radiant energy applicator, or an electrode. Id. at 16:23-24, 17: 13-22. After
the tissue has been coupled, the tissue can be allowed to ischemically regress
as a result of occlusion of blood vessels in the base of the tissue. Id. at
21:10-13.
Claims 20-24 and 30 are on appeal. Claim 20 is illustrative and reads
as follows:
20. A surgical method comprising:
providing an instrument assembly including a hollow
body member having a sidewall formed with a window and
further including a tissue occlusion component, said occlusion
component defining a pair of jaws, at least one of said jaws
including an arcuate clamping surface;
inserting said hollow body member into a body lumen of
a patient;
manipulating said hollow body member so that organic
tissues protrude through said window into said hollow body
member;
2 The line numbering on page 16 is incorrect: line 15 is not numbered and
what is actually line 20 is numbered "15". We refer to the actual number of
the relevant lines, not the number appearing in the margin of the page.
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Appeal2017---009595
Application 14/214,898
after the protruding of said tissues through said window,
manipulating said occlusion component so that said jaws are
located on opposite sides of the protruding tissues;
thereafter closing said jaws to clamp the protruding
tissues; and
subsequently operating said occlusion component to
permanently constrict a portion of said protruding tissues
without transecting said protruding tissues to effect ischemic
regression of said protruding tissues.
The claims stand rejected as follows:
Claim 30 under 35 U.S.C. § 112, second paragraph, as indefinite
(Final Action3 2);
Claims 20-24 under 35 U.S.C. § 103(a) as obvious based on Kaji4 and
Santos5 (Answer 2); and
Claims 20-24 under 35 U.S.C. § 103(a) as obvious based on Kaji and
Shadduck6 (Answer 4).
I
The Examiner rejected claim 30 as indefinite in the Final Action. In
response, Appellants amended claim 30 to change the phrase that the
Examiner found indefinite. Response filed Dec. 19, 2016, page 4. The
Examiner entered the amendment. Adv. Action 1, item 7. However, the
Examiner also indicated that the response did not overcome any of the
rejections set out in the Final Action. Id., item 5.
3 Office Action mailed Oct. 19, 2016.
4 Kaji, US 6,142,931 issued Nov. 7, 2000.
5 Santos, US 4,635,634 issued Jan. 13, 1987.
6 Shadduck, Us 7,674,259 B2 issued Mar. 9, 2010.
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Application 14/214,898
In the Answer, the Examiner stated that "[e]very ground of rejection
set forth in the Office action dated 10/19/16 from which the appeal is taken
is being maintained by the examiner except for the grounds of rejection (if
any) listed under the subheading 'WITHDRAWN REJECTIONS.'" The
Answer does not have a WITHDRAWN REJECTIONS subheading.
The Answer, however, does not include a rejection of claim 30 and
does not provide any reason for concluding that claim 30, as amended, is
indefinite. We therefore reverse the rejection of claim 30 under 35 U.S.C.
§ 112, second paragraph.
II
The Examiner has rejected claims 20-24 as obvious based on Kaji and
Santos. The Examiner finds that Kaji discloses a method meeting most of the
limitations of claim 20, but "Kaji teach[es] of using forceps or a knife for
cutting of a lesion [ and] is silent with respect to the occlusion component
permanently constricting a portion of the protruding tissues without
transecting the protruding tissues to effect ischemic regression of the
protruding tissues." Ans. 2-3.
The Examiner finds that "Santos teaches of an analogous medical
instrument relating to tissue occlusion means comprising a surgical clip
applicator. Specifically, the clip applier comprises jaw members 50, 60,
having an arcuate clamping surface 53, 65 useful in grasping tissue, and
clips 200 used to permanently compress tissue there between." Id. at 3. The
Examiner concludes that it would have been obvious to "use the tissue
occlusion instrument (i.e. clip applier) in combination with the device of
Kaji to enable a user an alternate method of treating tissue lesions/polyps
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Application 14/214,898
within a patient, thus allowing for a quicker and less painful
recovery/procedure, as taught by Santos and is extremely well known in the
art." Id.
Appellants argue, among other things, that "there is nothing in either
Kaji or Santos that would have suggested to one having ordinary skill in the
art at the time of the invention to modify the endoscope guide unit disclosed
by Kaji to include a clip applicator system for applying a clip configured for
blood vessel tissue occlusion such as taught by Santos." Br. 8.
We agree with Appellants that the Examiner has not shown that a
person of ordinary skill in the art would have had a reason to combine Kaji
and Santos. "[T]he 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 (Fed. Cir. 1992).
"[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007)
(quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
"The presence or absence of a motivation to combine references in an
obviousness determination is a pure question of fact." In re Gartside, 203
F.3d 1305, 1316 (Fed. Cir. 2000). "In rejecting an application, factual
determinations by the PTO must be based on a preponderance of the
evidence." In re Oetiker, 977 at 1449 (J. Plager, concurring).
Here, the Examiner's reason for combining the references is that
doing so would allow for "a quicker and less painful recovery/procedure, as
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Application 14/214,898
taught by Santos." Ans. 3. The Examiner, however, did not cite any evidence
in Santos to support that basis for combining the references, and none is
apparent to us from Santos's disclosure of a surgical clip assembly for blood
vessel or tissue occlusion that allows for clip closing control. See Santos
1:5-9, 4:24--31. The Examiner also stated that this result "is extremely well
known in the art." Ans. 3. Again, however, the Examiner cited no evidence
to support this position.
We conclude that the Examiner has not carried the initial burden of
making a prima facie case of obviousness. We therefore reverse the rejection
of claims 20-24 under 35 U.S.C. § 103(a) based on Kaji and Santos.
III
The Examiner has rejected claims 20-24 as obvious based on Kaji and
Shadduck. The Examiner finds that Kaji discloses a method meeting most of
the limitations of claim 20, but "Kaji teach[es] of using forceps or a knife for
cutting of a lesion [ and] is silent with respect to the occlusion component
permanently constricting a portion of the protruding tissues without
transecting the protruding tissues to effect ischemic regression of the
protruding tissues." Ans. 4--5.
The Examiner finds that "Shadduck teaches of an analogous medical
instrument relating to tissue occlusion means comprising a tissue-engaging
surfaces 20a-b for delivering thermal energy to tissue to weld tissue or cause
remolding of the tissue." Id. at 5. The Examiner concludes that it would have
been obvious
to use the tissue occlusion instrument in combination with the
device of Kaji to enable a user to seal, weld or create lesions in
selected tissue volumes without desiccation or charring of
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Id.
adjacent tissues, thus allowing for a quicker and less painful
recovery/procedure, as taught by Shadduck and is extremely
well known in the art.
Appellants argue that "there is nothing in either Shadduck or Kaji that
would suggest that thermal energy laden vapor would be effective in
performing the method taught by Kaji." Br. 16.
We agree with Appellants that the Examiner has not provided
evidence that Shadduck's device would be effective in, and therefore
obvious to combine with, Kaji's method. As with the previously discussed
rejection, the Examiner did not cite any evidence in Shadduck to show that
combining the references would "allow[] for a quicker and less painful
recovery/procedure" (Ans. 5), and none is apparent to us from Shadduck's
disclosure, which teaches, for example, using thermotherapy to seal the
medial portion of a polyp but to remove the thus sealed polyp protrusion
with a cutting instrument. See, e.g., Shadduck 6:55-7:3. The Examiner also
did not cite any evidence to support the position that this result "is extremely
well known in the art." Ans. 5.
We conclude that the Examiner has not carried the initial burden of
making a prima facie case of obviousness. We therefore reverse the rejection
of claims 20-24 under 35 U.S.C. § 103(a) based on Kaji and Shadduck.
SUMMARY
We reverse all of the rejections on appeal.
REVERSED
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