Ex Parte Jantzen et al

Patent Trial and Appeal Board

Jul 2, 2014

12411049 (P.T.A.B. Jul. 2, 2014)

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.
12/411,049 03/25/2009 Alexandra E. Jantzen 8627/2068
(PA-6564-RFB)
4425
48003 7590 07/02/2014
BGL/Cook - Chicago
PO BOX 10395
CHICAGO, IL 60610
EXAMINER
EASTWOOD, DAVID C
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
07/02/2014 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 ALEXANDRA E. JANTZEN and FRED T. PARKER
__________

Appeal 2012-004033
Application 12/411,049
Technology Center 3700
__________

Before ERIC B. GRIMES, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

PER CURIAM.

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1, 3-7, and 9.2 We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.

1 The Real Party in Interest is Cook Medical Technologies LLC (App.
Br. 2).
2 Claims 2, 8, 10, and 11 are also pending, but stand withdrawn from
consideration (App. Br. 2).
Appeal 2012-004033
Application 12/411,049

2
STATEMENT OF THE CASE
The Specification discloses “medical devices . . . for breaking down
and capturing a thrombus” (Spec. 1, ¶ 0001). Figure 1 of the Specification is
shown below:

Figure 1 shows a side cross-sectional view of an “everted sheath
thrombectomy device wherein the scraping device is a plurality of barbs”
(id. at 2, ¶ 0014). The Specification discloses that “inner catheter 14 is
disposed within the inner lumen 10 of the outer sheath 8” (id. at 3, ¶ 0026).
A“rollsock 20, or tube of flexible material everted upon itself, is provided,”
such that first and second ends of the rollsock are attached to the distal ends
of the outer sheath and the inner catheter, respectively (id. at 3-4, ¶ 0026).
According to the Specification, “scraping device 30 is attached to the outer
surface 26 of the rollsock 20 . . . [and] may be a plurality of barbs 32” (id. at
4).
Claim 1 is representative and reads as follows:
1. A medical device, comprising:
an outer sheath having a distal end and an inner lumen;
an inner catheter having a distal end and an inner lumen, wherein said
inner catheter is disposed with said inner lumen of said outer sheath;
a rollsock with a first end and a second end and an outer surface;
said distal end of said outer sheath connected to said first end of said
rollsock;
said distal end of said inner catheter connected to said second end of
said rollsock;
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Application 12/411,049

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said rollsock everted upon itself;
a scraping device attached to said outer surface of said rollsock;
wherein said outer sheath may be moved relative to said inner catheter
such that said scraping device is exposed to an inner surface of a body
vessel.

Issue
The Examiner has rejected claims 1, 3-7, and 9 under 35 U.S.C.
§ 103(a) as obvious over the combination of Lowery3 and MacLean4 (Ans.
4-7). Claims 3-7 and 9 have not been argued separately from claim 1 and
therefore stand or fall with that claim. 37 C.F.R. § 41.37 (c)(1)(vii).
The issue presented is: Has the Examiner established by a
preponderance of the evidence that the combination of Lowery and
MacLean would have made obvious the medical device of claim 1 that
comprises an outer sheath, an inner catheter, and a rollsock having an outer
surface such that “a scraping device [is] attached to said outer surface of said
rollsock” as required by claim 1?
Findings of Fact
FF1. The Examiner finds that Lowery discloses a medical device
comprising an outer sheath (19) and an inner catheter (33), wherein the inner
catheter is disposed within the inner lumen of the outer sheath (Ans. 5
(citing Fig. 3A of Lowery)).
FF2. The Examiner finds that Lowery’s medical device further
comprises a rollsock (17) having a first end connected to the outer sheath
and a second end connected to the inner catheter (id.).

3 Lowery et al., US 5,364,345, issued Nov. 15, 1994.
4 MacLean, US 2,955,592, issued Oct. 11, 1960.
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Application 12/411,049

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FF3. Lowery discloses a “method of tubal recanalization comprising
advancing an everting catheter adapted for dilatation and an endoscope to a
position adjacent the site of a stenosis in an internal tubal passage of a
patient” (Lowery, abstract).
FF4. Figures 3 and 3A of Lowery are shown below:

Figure 3 shows “an enlarged, fragmentary, axial sectional view of a distal
region of the everting catheter and endoscope with the everting element
partially everted” (id. at col. 3, ll. 56-62). Figure 3A shows “a preferred way
to move the endoscope relative to the everting element” (id. at col. 3, ll. 56-
62).
FF5. Lowery discloses that the “everting catheter 11 generally
comprises an outer catheter 13, an inner catheter 15 and an everting element
17” (id. at col. 4, ll. 19-20).
FF6. Lowery discloses that “the everting element 17 is advanced into
or through the stenosis . . . [and then ] expanded by increasing the pressure
in the chamber 47 . . . to compact and reduce the stenosis” (id. at col. 7, ll.
53-60).
FF7. The Examiner finds that Lowery does not “disclose a scraping
device attached to said outer surface of said rollsock” (Ans. 5).
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Application 12/411,049

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FF12. MacLean discloses that “[s]carifying, collecting and retaining
structures are associated with body 52, preferably by mounting on the latter
a number of strands in the form of tufts or bristles 54” (id. at col. 5, ll. 11-
14).
FF13. MacLean discloses that when the tufts or bristles “are wiped
across a tissue surface, they will remove and retain a certain amount of
cells” (id. at col. 5, ll. 16-18).
FF14. The Examiner concludes that it would have been obvious to
one of ordinary skill in the art to apply MacLean’s teaching of a scraping
device to the Lowery rollsock in order to “improve the effectiveness of the
device of Lowery for removing stenosis from a vessel” (Ans. 5).
FF15. The Examiner reasons that “[s]uch a combination would
provide a device wherein said outer sheath may be moved relative to said
inner catheter (as disclosed by Lowery) such that said scraping device (as
disclosed by Mac[L]ean) is exposed to an inner surface of a body vessel (as
disclosed by Lowery)” (id. at 5-6).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability. For the same
reason, if a technique has been used to improve one device, and
a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond his
or her skill.
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Application 12/411,049

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Id. at 417. In determining whether obviousness is established by combining
the teachings of the prior art, “the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425 (CCPA 1981).
Analysis
Appellants argue that “Lowery, MacLean and the claimed inventions
are so unrelated to each other that one of ordinary skill in the art would not
have considered it to be apparent that Lowery and MacLean could be
combined to achieve” the instant claims (Reply Br. 2). Appellants argue that
the “Examiner fails to recognize that a stenosis and a thrombus are two
different things” (id.). Appellants argue that “Lowery is related to treating a
stenosis; the claimed inventions are related to treating a thrombus; and
MacLean is not related to either one” (id.). Appellants argue that the “only
support that the Examiner could be relying upon for the suggestion that
bristles would improve stenosis removal is MacLean’s use of bristles,” but
MacLean offers no support for this conclusion because it is unrelated to
treating a stenosis with an expandable member (id. at 2-3).
Those arguments are not persuasive. The instant claims are not
directed to a method for treating a thrombosis, but rather are directed to a
medical device. Thus, the Examiner did not err in relying on Lowery, which
discloses a device that meets most of the limitation of the device of claim 1,
even though it is used to treat restenosis. Appellants’ arguments that neither
Lowery nor MacLean disclose the use of bristles to treat restenosis is not
persuasive because the Supreme Court has emphasized that “the
[obviousness] analysis need not seek out precise teachings directed to the
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Application 12/411,049

8
specific subject matter of the challenged claim, for a court can take account
of the inferences and creative steps that a person of ordinary skill in the art
would employ.” KSR, 550 U.S. at 418. We agree with the Examiner that, in
view of the inferences and creative steps that the artisan of ordinary skill
would employ, Lowery’s disclosure of stenosis treatment by compaction and
reduction of the stenosis would have made obvious the use of bristles, which
MacLean discloses may be used to remove cells (FF 13), as an aid for
stenosis treatment as taught by Lowery.
Appellants argue that the combination of Lowery and MacLean would
not have made obvious the medical device of claim 1 because neither
reference discloses abrader elements on a rollsock (App. Br. 4-5).
Appellants also argue that MacLean’s “abrader element . . . is not everted
upon itself, nor is it capable of capturing a thrombosis as contemplated by
the claimed invention” (id. at 5). Appellants argue that MacLean does not
disclose the use of the device to “relieve any sort of blockage in a body
vessel” or use of the device in a body vessel, rather MacLean teaches its use
in an organ, such as the stomach or lung (id. at 7).
Those arguments are not persuasive. In accord with In re Keller, the
test for obviousness “is what the combined teachings of the references would
have suggested to those of ordinary skill in the art.” Keller, 642 F.2d at 425.
Here, Lowery discloses a medical device comprising a rollsock and, as
discussed above, we agree with the Examiner that one of ordinary skill in the
art would have been motivated to apply bristles, as disclosed by MacLean, to
Lowery’s rollsock. The Examiner relies on MacLean only to show that
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Application 12/411,049

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bristles on an extendible body may be used to remove material from the wall
of a body structure.
Appellants argue that adding MacLean’s bristles to Lowery’s everting
catheter “would defeat an intended purpose of Lowery, namely reducing a
stenosis” (App. Br. 7, emphasis deleted). Appellants argue that bristles
attached to Lowery’s rollsock “would constitute an unwanted barrier or layer
between the dilation everting catheter and body vessel that could make the
pressure exerted upon the stenosis unpredictable” (id. at 8). Appellants
argue that bristles attached to Lowery’s rollsock “would cause unwanted and
unnecessary trauma to the internal passage as the everting catheter was
inflated” (id.).
Those arguments are not persuasive. As recognized by the Examiner
(Ans. 10), the purpose of Lowery’s device is to compact and reduce the
stenosis, i.e., to disrupt the shape of the stenosis, and thus Appellants’
argument that bristles would result in unpredictable pressure on the stenosis
is not persuasive. Additionally, modification of Lowery’s device with a
scraping element, i.e., bristles, would provide an alternative method of
removing stenosis. Appellants’ argument that bristles attached to Lowery’s
dilation everting catheter would cause trauma to the internal passage as the
everting catheter was inflated is not persuasive. Optimizing the position or
dimensions of Lowery’s inflatable rollsock so that it can be inflated to
compress or remove the stenotic material without directly contacting the
vessel wall would appear to be within the level of ordinary skill in the art.
Appellants argue that adding MacLean’s bristles to Lowery’s everting
catheter would disrupt the Lowery purpose of “providing an endoscope to
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Application 12/411,049

10
view a stenosis” (App. Br. 8, emphasis deleted). Appellants argue that
bristles attached to the outside surface of Lowery’s everting element “would
come into direct contact with the endoscope, diminishing the gripping action
of the everting catheter taught in Lowery” (id.). Appellants also argue that
the addition of bristles to Lowery’s device would “obstruct the field of
vision of the endoscope of Lowery, frustrating the purpose of the
endoscope,” which is to observe the stenosis before and after reduction (id.).
That argument is not persuasive. As recognized by the Examiner,
“portions of the everting element that contact the stenosis could hold
scraping elements . . . without ever contacting the endoscope” (Ans. 9).
That is, scraping elements could be positioned so that a portion of the
everting element that grasps the endoscope would not have scraping
elements. Further, with regard to viewing the stenosis, Lowery expressly
discloses independent movement of the endoscope with respect to the
everting catheter to better view the stenosis. Thus, Appellants’ argument
that bristles or scraping elements would frustrate the use of the endoscope to
view the stenosis is not persuasive.
Thus, we affirm the rejection of claim 1 as being obvious over the
combination of Lowery and MacLean. Claims 3-7 and 9 have not been
argued separately from claim 1 and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(vii).
Conclusion of Law
The preponderance of the evidence supports the Examiner’s
conclusion that the combination of Lowery and MacLean would have made
obvious the medical device of claim 1 that comprises an outer sheath, an
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Application 12/411,049

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inner catheter, and a rollsock having an outer surface such that “a scraping
device [is] attached to said outer surface of said rollsock” as required by
claim 1.
SUMMARY
We affirm the rejection claims 1, 3-7, and 9 under 35 U.S.C. § 103(a).
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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