Ex Parte Bertrand et al

Patent Trial and Appeal Board

Jul 19, 2018

13276155 (P.T.A.B. Jul. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/276, 155 10/18/2011 William Jeffrey Bertrand
63496 7590 07/23/2018
DICKE, BILLIG & CZAJA, PLLC
ATTN: MDT SURGICAL TECHNOLOGIES MATTERS
FIFTH STREET TOWERS, SUITE 2250
100 SOUTH FIFTH STREET
MINNEAPOLIS, MN 55402
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.
P0041079.USU1 1441
EXAMINER
ZIMBOUSKI, ARIANA
ART UNIT PAPER NUMBER
3761
NOTIFICATION DATE DELIVERY MODE
07/23/2018 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):
USPTO.PA TENTS@dbclaw.com
DBCLA W-Docket@dbclaw.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM JEFFREY BERTRAND and ROBERT C. LEONARD
Appeal2016-005993
Application 13/276,155
Technology Center 3700
Before GEORGE R. HOSKINS, BRANDON J. WARNER, and
FREDERICK C. LANEY, Administrative Patent Judges.
HOSKINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
William Jeffrey Bertrand and Robert C. Leonard ("Appellants") 1
appeal under 35 U.S.C. § 134 from the Examiner's decision rejecting
claims 1-20 in this application. The Board has jurisdiction over the appeal
under 35 U.S.C. § 6(b ).
We AFFIRM.
1 The Appeal Brief identifies Medtronic Xomed Inc. as the real party in
interest. Appeal Brief (filed July 16, 2015, hereafter "Appeal Br."), 3.
Appeal2016-005993
Application 13/276,155
CLAIMED SUBJECT MATTER
Claim 1 illustrates the subject matter on appeal, and it recites (with
line breaks added):
1. A combination of a catheter and a stylet comprising:
a catheter made of an elastomeric material, comprising an
elongate body having a proximal end and defining within itself a
lumen having an inner diameter and an elastomeric inner surface
defining the inner diameter and a circular cross-section over its
entire length; and
a stylet comprising a stylet body having an outer surface
in frictional contact with the elastomeric inner surface of the
lumen, the stylet comprising an elongate stylet body having a
proximal end, a distal end, and a non-circular cross-section
having a regular polygonal cross-section defining the outer
surface to have at least three faces for at least a majority of stylet
length in frictional contact with the elastomeric inner surface of
the lumen of the catheter;
in which the stylet further includes a stylet distal end
having an outer diameter less than the lumen inner diameter such
that the stylet distal end is entirely removable from the proximal
end of the lumen of the catheter by passing the distal end of the
sty let through the proximal end of the catheter.
Appeal Br. 17 (Claims App.).
REJECTIONS ON APPEAL
Claims 1, 3, 4, 6, 13, 15, 16, and 18 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Bostrom (US 5,728,148, iss. Mar. 17, 1998)
and Williamson (US 3,419,010, iss. Dec. 31, 1968).
Claims 2, 5, 14, and 17 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Bostrom, Williamson, and Balbierz (US 6,770,038 B2,
iss. Aug. 3, 2004).
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Application 13/276,155
Claims 7-9, 19, and 20 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Bostrom, Williamson, and Schorn (US 2008/0103448 Al,
pub. May 1, 2008).
Claims 10-12 stand rejected under 35 U.S.C. § I03(a) as unpatentable
over Schorn, Bostrom, and Williamson.
ANALYSIS
A. Obviousness based on Bostrom and Williamson
(Claims 1, 3, 4, 6, 13, 15, 16, and 18)
Appellants argue for the patentability of claims 1, 3, 4, 6, 13, 15, 16,
and 18 together in one group, and do not argue for the patentability of any
one claim separately from the other claims. See Appeal Br. 9-12.
Accordingly, we select claim 1 to decide the present appeal as to all claims
in this group. See 37 C.F.R. § 4I.37(c)(l)(iv).
The Examiner finds Bostrom discloses a catheter and stylet
combination exhibiting some of the limitations recited in claim 1. Non-Final
Act. 4--5. The Examiner cites Bostrom's statement that "[t]he present
invention relates to a stylet unit, which can be inserted into an elongate
means with an internal longitudinal channel, such as an electrode cable for a
heart stimulator, a coronary catheter or some other kind of hollow, oblong
instrument." Bostrom, 1: 6-10 ( emphases added); Non-Final Act. 4
(additionally citing Bostrom, 2:4--9, 4:4--11). Bostrom's referenced "stylet
unit" may be a double stylet unit, such as unit 22 illustrated in Figures 2 and
3 of Bostrom, comprised of "a flexible, tubular sty let sleeve 24 and an inner
sty let 26 movingly arranged inside the sleeve channel." Bostrom, 1: 5-14,
6:21-24.
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Application 13/276,155
The Examiner relies on Bostrom's "coronary catheter" as
corresponding to the claimed "catheter," and relies on Bostrom's "inner
stylet 26" as corresponding to the claimed "stylet." Non-Final Act. 2-3, 4--
5; Ans. 2--4. The Examiner finds Bostrom's catheter-stylet combination
satisfies every limitation in claim 1, except the catheter is not disclosed as:
(1) being "made of an elastomeric material"; (2) having a lumen with "a
circular cross-section over its entire length"; or (3) having a lumen diameter
such that the distal end of the sty let is entirely removable from the proximal
end of the catheter. Non-Final Act. 4--5. The Examiner finds Williamson
discloses a catheter-stylet combination having each of the features (1}-(3)
lacking in Bostrom, and provides various reasons why it would have been
obvious to modify the Bostrom catheter-stylet combination to include those
features. Id. at 5---6. We discuss each feature (1 }-(3) in tum.
(1) Catheter Made of Elastomeric Material
The Examiner finds Bostrom "does not disclose the material" of its
coronary catheter. Non-Final Act. 5; see also id. at 2-3; Ans. 3. The
Examiner determines it would have been obvious to make the Bostrom
catheter of an elastomeric material, such as taught by Williamson, because
this would advantageously "mak[e] it easier to navigate within the body."
Non-Final Act. 5---6 (citing Williamson, 2:16-19).
Appellants assert "Bostrom is not simply silent on the issue of the
catheter material selection, but explicitly teaches a non-elastomeric
material" - i.e., metal and preferably steel- which is a critical
requirement in Bostrom. Appeal Br. 8 ( citing Bostrom, 7: 18-20), 9-10.
Appellants additionally contend the Examiner's rationale is "too vague to
ascribe to materials properties with any degree of certainty." Id. at 10.
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Application 13/276,155
Appellants' arguments are not persuasive. Bostrom discloses that
inner stylet 26 and stylet sleeve 24 are made of metal. Bostrom, 7:18-20.
Bostrom is silent concerning the material of its coronary catheter. See id. at
1 : 6-19, 2: 4--9, 4: 4--11. A person of ordinary skill in the art would appreciate
that Bostrom' s coronary catheter must be made of some sort of appropriate
material, and the Examiner's finding that Williamson discloses an
elastomeric material as a suitable option is supported by the evidence of
record. See Williamson, Figs. 1-2, 2:16-19. The Examiner's conclusion
that this would have been done to ease navigation of the catheter within the
body of a patient is not vague, as Appellants would have it. See Non-Final
Act. 5-6; Appeal Br. 10; Ans. 5---6 ("a person having the knowledge
generally available to one of ordinary skill in the art would know that a
catheter made from the elastomeric material disclosed by Williamson,
silicone rubber, would be flexible, which would help with navigation within
a body").
For the foregoing reasons, we discern no error in the Examiner's
determination that it would have been obvious to make the Bostrom catheter
of an elastomeric material, as taught by Williamson.
(2) Catheter Lumen has Circular Cross-Section Over its Entire Length
The Examiner concludes making the Bostrom catheter to have a
circular cross-section lumen over its entire length would have been obvious
because "circular catheters are well known and used in the art for treating
patients." Non-Final Act. 5---6 (citing Williamson, Figs. 1-2).
Appellants argue "[t]he Bostrom configuration is not compatible with
a circular catheter [lumen] because the [ anti-]rotation necessarily required by
Bostrom is not possible" with a circular lumen. Appeal Br. 9, 11-12
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Application 13/276,155
(emphasis added); see also id. at 7-8 (citing Bostrom, 6:49-7:13). This
argument is premised upon a misunderstanding that Bostrom's stylet
sleeve 24 corresponds to the claimed catheter. See id. Instead, as discussed
above, the Examiner relies on Bostrom' s coronary catheter as the claimed
catheter. Bostrom's coronary catheter can be made to have a circular
cross-section lumen to receive double stylet unit 22, while inner stylet 26
and stylet sleeve 24 are prevented from relative rotation by having matching
non-circular cross-sections such as illustrated in Figures 7c and 7d of
Bostrom. Therefore, Appellants' argument is not persuasive of Examiner
error.
Appellants also address the Examiner's reliance on Bostrom's
coronary catheter, as follows:
This intermediate stylet sleeve [i.e., stylet sleeve 24] physically
prevents the stylet [i.e., inner stylet 26] (lying wholly inside the
inner diameter of the sty let sleeve [24]) from physically
(frictionally) contacting the inner surface of the elastomeric
catheter channel (lying wholly outside the outer diameter of the
stylet sleeve [24]).
Appeal Br. 8.
The Examiner disagrees, and finds Bostrom's inner stylet 26
"interacts with a catheter when the stylet [26] is deployed outside the
opening of the sty let sleeve [24] in order to 'bend[] the corresponding
section of the surrounding channel-equipped means which (as noted above)
can be ... a catheter."' Ans. 4 (quoting Bostrom, 2:2-8). Thus, the
Examiner's view is that "sty let sleeve [24] does not prevent the sty let [26]
from physically, including frictionally, contacting the inner surface of the
catheter channel because the stylet [26] would push on the inner surface of
the channel in order to bend it." Id.
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In reply, Appellants contend the cited Bostrom disclosure reflects only
"limited contact of the distal-most portion of the Bostrom sty let [26]" with
the catheter. Reply Br. 3. According to Appellants, such limited contact "is
not the same as the claimed stylet which has a non-circular profile 'for at
least a majority of stylet length in frictional contact with the elastomeric
inner surface of the lumen of the catheter.'" Id. ( quoting claim 1 ).
During examination of a patent application, pending claims are given
their broadest reasonable construction consistent with the Specification.
In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
The claim limitation at issue here requires the stylet to comprise "a
non-circular cross-section having a regular polygonal cross-section defining
the outer surface to have at least three faces for at least a majority of stylet
length in frictional contact with the elastomeric inner surface of the lumen of
the catheter." Appeal Br. 17 (Claims App.). Appellants read this limitation
to require that a majority of the entire length of the sty let has a non-circular
cross-section which frictionally contacts the lumen surface of the catheter.
Reply Br. 3. That conclusion is not accompanied by any consideration of
supporting disclosure in the Specification. Id.
We do not find disclosure in the Specification which would lead to
Appellants' narrow reading of claim 1. We, instead, construe the limitation
at issue to require that a majority of the length of the sty let which frictionally
contacts the lumen surface of the catheter has the non-circular cross-section.
This reading of the claim is consistent with the Specification's disclosure
that the stylet's non-circular cross-section "may be the entire length of the
sty let, or only that distal portion of the length which is within a catheter
having a lumen with a circular cross-section." Spec. ,r,r 4--5 ( emphasis
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added); see also id. ,r 27 (stylet may be "non-circular in cross-section over
its distal portion (most preferably the portion within the catheter lumen), but
its proximal portion is circular in cross-section so that the 'feel' of the sty let
in the hand of the surgeon is not changed").
A preponderance of the evidence, firstly, supports the Examiner's
finding that Bostrom's inner stylet 26 frictionally contacts the lumen surface
of the catheter when inner sty let 26 is extended outside of sty let sleeve 24
within the catheter. See Bostrom, 1 :6-9, 1 :66-2:9 ("When this pre-bent end
section [ of inner sty let 26] is deployed outside the opening of the sty let
sleeve [24], it bends the corresponding section of the surrounding
channel-equipped means" such as a coronary catheter); see also id. at Fig. 6,
8: 15--44 (when inner stylet 26 is deployed outside of stylet sleeve 24 within
electrode cable 34, the physical interaction between inner stylet 26 and
cable 34 results in the fishhook shape illustrated in Figure 6).
A preponderance of the evidence, secondly, indicates a majority of the
length of inner sty let 26 which frictionally contacts the catheter's lumen
surface has a non-circular cross-section. Bostrom indicates it is the distal
end portion of inner stylet 26 (i.e., the portion which is deployed outside of
stylet sleeve 24 into the catheter) which has a non-circular profile to prevent
relative rotation with sleeve 24. See Bostrom, 1:65-2:16, 2:24--29, 2:40-57,
6:42-7:5, 7:36--40, 9: 19-23.
For the foregoing reasons, we discern no error in the Examiner's
determination that it would have been obvious to make the Bostrom catheter
with a circular cross-section lumen over its entire length, as taught by
Williamson, to receive double style unit 22. In addition, if one were to make
the Bostrom catheter with a circular cross-section lumen, then a majority of
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Application 13/276,155
the length of Bostrom's inner sty let 26 which frictionally contacts the
catheter's lumen would have a non-circular cross-section.
(3) Catheter has Lumen Diameter such that Distal End of Sty let is
Entirely Removable from Proximal End of Catheter
The Examiner finds that, while Bostrom does not disclose "the inner
diameter size of the catheter," Bostrom "discloses moving the distal end of
the sty let within the catheter so at least some portion of the outer diameter of
the sty let must be less than the lumen inner diameter of the catheter."
Non-Final Act. 5 (citing Bostrom, 2:1-9). The Examiner determines it
would have been obvious "to have the stylet have an outer diameter less than
the lumen inner diameter of the catheter such that the sty let distal end be
entirely removable from the catheter by passing the distal end of the sty let
through the proximal end of the catheter, as taught by Williamson, in order
to set the combination of Bostrom and Williamson up properly and to
replace parts as required." Id. at 6 (emphasis added).
Appellants assert "[t]he Examiner gives no rational explanation or
citation to the record to identify what 'set up properly' even means, much
less why it supports a conclusion of obviousness." Appeal Br. 11.
Appellants additionally contend invasive medical devices are required by
law to be disposable after a single use, so "[r]eplacement of parts is not
relevant and therefore cannot justify" the Examiner's conclusion of
obviousness. Id.
The Examiner responds that the need to replace parts is a rational
underpinning for the proposed obviousness. Ans. 6. "For instance, if for
some reason the stylet malfunctioned during use with a catheter and the
stylet had to be immediately replaced, being able to remove the entire stylet
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Application 13/276,155
and replace it without also removing the catheter would be desirable and
save time." Id.
We determine the Examiner has provided a rational underpinning
sufficient to support the legal conclusion of obviousness. See In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR Int'! Co. v.
Teleflex Inc., 550 U.S. 398,418 (2007). We understand the Examiner's
reference to "set the combination of Bostrom and Williamson up properly"
to relate to setting the device up to be manufactured, or setting the device up
for use immediately prior to a medical procedure. In either context, sizing
the lumen diameter of Bostrom's catheter such that double sty let unit 22 is
freely moveable therein, including having the distal end of stylet unit 22 be
entirely removable from the proximal end of the catheter, would ease the
setting up process.
Further, we agree with the Examiner that such a configuration would
enable parts to be replaced as required. Regardless of whether any given
catheter-stylet combination may be used only once, it may be that parts need
to be replaced before the device is used even once, or during the middle of a
single usage within one patient. Sizing the inner diameter of Bostrom's
catheter such that double stylet unit 22 is freely moveable therein, including
having the distal end of the sty let unit 22 be entirely removable from the
proximal end of the catheter, would ease the parts replacement process.
For the foregoing reasons, we discern no error in the Examiner's
determination that it would have been obvious to make the Bostrom catheter
have a lumen diameter such that the distal end of double stylet unit 22 is
entirely removable from the proximal end of the catheter.
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(4) Conclusion
We sustain the rejection of claims 1, 3, 4, 6, 13, 15, 16, and 18 as
having been obvious over Bostrom and Williamson.
B. Obviousness based on Bostrom, Williamson, and Balbierz
(Claims 2, 5, 14, and 17)
Claim 2
Claim 2 depends from claim 1, to add that "at least one face of the
stylet outer surface is concave." Appeal Br. 17 (Claims App.). In rejecting
claim 2, the Examiner relies on Bostrom and Williamson for the subject
matter of claim 1 as set forth above, and cites Balbierz as disclosing a
concave stylet face, thereby "allowing for a significant increase over prior
art in fluid flow area." Non-Final Act. 8-9 (citing Balbierz, Figs. 6A---6C,
7: 14--26). The Examiner determines it would have been obvious to have at
least one face of the sty let outer surface in the combination of Bostrom and
Williamson be concave, "in order to have a high percentage of fluid flow
area while using the stylet." Id. at 9.
Appellants argue the "regular polygonal cross-section" of parent
claim 1 is "contrary to the suggestion of Balbierz." Appeal Br. 12. In
Appellants' view, "[t]he stated purpose ofBalbierz is to support and prevent
collapse of a vascular access catheter" while also "allow[ing] flushing with
heparin and infusion of other solutions such as chemotherapeutics." Id. at
11-12. Appellants contend: "While use of such flushing solution to ease
removal of the sty let is disclosed, modification of sty let geometry [i.e., to
have a non-circular outer surface cross-section] to ease removal is not taught
or suggested." Id. at 12.
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Appellants' arguments are not persuasive of Examiner error. As
discussed above, the combination of Bostrom and Williamson discloses the
claimed non-circular cross-section stylet geometry of claim 1. Appellants do
not dispute the Examiner's finding that Balbierz discloses the concave stylet
face recited in claim 2. Non-obviousness cannot be established by attacking
references individually when unpatentability is predicated upon a
combination of prior art disclosures. In re Merck & Co., Inc., 800 F.2d
1091, 1097 (Fed. Cir. 1986). Further, Appellants do not cite any disclosure
in the prior art which would teach away from or discourage the use of a
concave sty let face within the combined device of Bostrom and Williamson.
For the foregoing reasons, we sustain the rejection of claim 2 as
having been obvious over Bostrom, Williamson, and Balbierz.
Claims 5, 14, and 17
Appellants do not present any additional arguments for the
patentability of claims 5, 14, and 17 over Bostrom, Williamson, and
Balbierz. See Appeal Br. 12-13, 14. Therefore, for the reasons provided
above, we sustain the rejection of claims 5, 14, and 17.
C. Obviousness based on Bostrom, Williamson, and Schorn
(Claims 7-12, 19, and 20)
Appellants do not present any additional arguments for the
patentability of claims 7-12, 19, and 20 over Bostrom, Williamson, and
Schorn. See Appeal Br. 13, 14--15. Therefore, for the reasons provided
above, we sustain the rejections of claims 7-12, 19, and 20.
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DECISION
The rejections of claims 1-20 are each affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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