Ex Parte Neidert et al

Patent Trial and Appeal Board

Jul 31, 2017

12643737 (P.T.A.B. Jul. 31, 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.
12/643,737 12/21/2009 Michael R. Neidert P0025539.02/LG10126 5046
27581 7590
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
WILSON, KAYLEE R
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
08/02/2017 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):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL R. NEIDERT and NIALL DUFFY1
Appeal 2016-003749
Application 12/643,737
Technology Center 3700
Before DONALD E. ADAMS, JOHN G. NEW, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellants state the real parties-in-interest are Medtronic, Inc. of
Minneapolis, Minnesota, the assignee of record, and Medtronic pic of
Dublin, Ireland. App. Br. 2.
Appeal 2016-003749
Application 12/643,737
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Non-Final Rejection of claims 1, 3, 5—13 and 20. Specifically,
claims 1,3, 5—8. 11—13 and 20 stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over the combination of Belson (US
2006/0235458 Al, October 19, 2006) (“Belson”) and Bardsley et al. (US
6,004,310, December 21, 1999) (“Bardsley”),
Claim 9 stands rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over the combination of Belson, Bardsley, and Raulerson et
al. (US 2005/0137580 Al, June 23, 2005 (“Raulerson”).
Claims 10 stands rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Belson, Bardsley, and
Mclvor et al. (US 6,379,346 Bl, April 30, 2002) (“Mclvor”).
We have jurisdiction under 35 U.S.C. § 6(b)
We AFFIRM.
NATURE OF THE CFAIMED INVENTION
Appellants’ invention is directed to a catheter system for positioning
of a medical instrument includes a first elongate member having a first
lumen. The system also includes a second elongate member that includes a
second lumen that receives the medical instrument. Abstract.
REPRESENTATIVE CLAIM
Claim 1 representative of the remaining claims. Claim 1 recites:
1. A catheter system for positioning of a medical
instrument, wherein the medical instrument includes a lead
positionable within a body, the catheter system comprising:
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a first elongate member that includes a first lumen
extending along a first longitudinal axis;
a second elongate member that includes a second lumen
extending along a second longitudinal axis and configured to
receive the medical instrument, the second elongate member
being coupled directly to the first elongate member, the second
elongate member being in a normally collapsed state when the
first and second elongate members are positioned within the
body, wherein the second elongate member is expandable to
change a size of the second lumen when a working fluid is
introduced therein when the first and second elongate members
are positioned within the body, and further wherein a reinforcing
member extends at least partially along the first longitudinal axis
to reinforce the first elongate member to increase a rigidity
thereof; and
a navigation tool operable to allow detection of a location
of the catheter system when the first and second elongate
member are positioned within the body, the navigation tool being
received in the first lumen, wherein the first lumen is configured
to receive the navigation tool when the first and second elongate
members are positioned within the body, wherein a wall
thickness of the second elongate member is at least 6 times
thinner than a wall thickness of the first elongate member such
that the second elongate member is cuttable without cutting the
first elongate member and the navigation tool to allow removal
of the first and second elongate member from the body while the
lead remains positioned in the body.
Claim App’x 1.
ISSUES AND ANALYSIS
We agree with, and adopt, the Examiner’s reasoning and conclusion
that the claims on appeal are prima facie obvious over the combined cited
prior art. We address the arguments presented by Appellants below.
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Issue
Appellants argue the Examiner erred in finding the combined cited
prior art references teaches or suggests the limitations of claim 1 reciting “a
reinforcing member extends at least partially along the first longitudinal axis
to reinforce the first elongate member to increase a rigidity thereof’ and
“wherein a wall thickness of the second elongate member is at least 6 times
thinner than a wall thickness of the first elongate member such that the
second elongate member is cuttable,” as recited in claim 1.
Analysis
“A reinforcing member extends at least partially along the first longitudinal
axis to reinforce the first elongate member to increase a rigidity thereof’
Appellants point out that the Examiner relies upon Belson as teaching
most of the limitations of claim 1, but acknowledges that Belson is silent
with respect “to a reinforcing member extending at least partially along the
first longitudinal axis to reinforce the first elongate member to increase
rigidity thereof.” App. Br. 11 (quoting Final Act. 4). Appellants assert that,
to cure this alleged deficiency, the Examiner relies upon Bardsley which, the
Examiner finds, teaches such a reinforcing member. Id. (citing Bardsley
Fig. 3). Appellants contend the Examiner finds Bardsley teaches that the
reinforcing member is constructed of polymeric or metallic braid, coil or
knit material that extends at least partially along the axis and reinforces an
elongate member to increase rigidity. Id. (citing Bardsley Fig. 5; col. 6,11.
14—23). Appellants argue the Examiner concludes that it would have been
obvious to one of ordinary skill the art “to provide the first longitudinal axis
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of the first elongate member of Belson with a braided or helical reinforcing
member like that of Bardsley in order to ensure that the cross-sectional
shape of the first lumen remains undistorted as it undergoes the high flexure
encountered during traversal through the body.” Id. at 11—12 (citing Final
Office Action, pages 4—5 (citing Bardsley col. 6,11. 14—23)).
Appellants contend the Examiner failed to mention that the
reinforcing member of Bardsley is used to reinforce a very thin second
elongate member (e.g., the inner member 130) which is contrary to the
Examiner’s alleged obvious use thereof in Belson. App. Br. 12. Appellants
argue, by way of example, Bardsley teaches that the inner member 130 (i.e.,
the reinforced, more rigid, second elongate member) “preferably has a
thickness of about 0.00075 inches or less, more preferably about 0.0005
inches or less.” Id. (quoting Bardsley col. 7,11. 15—17; also citing Bardsley
Figs. 2, 3). Appellants assert that Bardsley also teaches that this thickness of
a portion of the support member 135 is only possible because the
reinforcement allows the inner member 130 to be “extraordinarily thin
walled.” Id. (quoting Bardsley col. 6,11. 21—22). In other words, argue
Appellants, Bardsley teaches only reinforcing this “extraordinarily thin
walled” member 130. Id. Appellants therefore contend that the Examiner
erroneously concludes that it would be obvious that the thicker wall of the
first elongate member of Belson, which already provides additional rigidity
relative to the second elongate member, could be further reinforced with the
reinforcing member 135 taught by Bardsley. Id. at 14.
Appellants argue further that, contrary to the Examiner’s findings, if
Bardsley teaches anything about the use of reinforcing members, it teaches
that a thinner walled elongate member is the member requiring
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reinforcement. App. Br. 13. Appellants therefore assert that Bardsley
teaches away from reinforcing the thicker first elongate member 30 of
Belson. Id. Appellants assert that, rather, one skilled in the art would not
reinforce the already thick first elongate member 30 of Belson, especially
when considering the reinforcement described in Bardsley relates to an
“extraordinarily thin walled” elongate member. Id. at 14. Appellants
conclude that there is therefore no rational underpinning that would support
such a modification of Belson by one of skill in the art. Id.
In summary, argue Appellants, the use of the reinforcing member 135
in Bardsley is limited to reinforcing the “extraordinarily thin walled”
member 130. App. Br. 15. According to Appellants, for the Examiner to
allege that it would be obvious to use this reinforcing member 135 to
reinforce the relatively thick walled first elongate member of Belson to
achieve the structure as set forth in the pending claims is ignoring the
teachings of Bardsley when viewed as a whole in its entirety. Id. As such,
Appellants argue, Bardsley therefore teaches away from the modification to
Belson proposed by the Examiner. Id.
The Examiner responds that Bardsley, taken as a whole, is relied upon
as teaching that it was known in the art to reinforce an elongate catheter
member, thin walled or not, with a reinforcing member so as to increase the
rigidity of the catheter member. Ans. 13. The Examiner finds that, a person
of ordinary skill in the art, having been apprised of the teachings of Belson
and Bardsley, would have recognized that providing reinforcing members
the catheter shaft of Belson would also allow for increased rigidity of the
catheter shaft so as to ensure that the cross-sectional shape of the catheter
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shaft remains undistorted as it undergoes the high flexure encountered
during traversal through the body. Id.
The Examiner additionally finds that, in order to increase rigidity of
the catheter shaft of Belson it would have been obvious to one of ordinary
skill the art, given the teachings of Belson and Bardsley, to provide the
reinforcing members to the thicker first elongate member of Belson, as
opposed to the thinner second elongate member so as not to destroy the
principle operation of the second elongate member, which is to be
selectively collapsible and expandable. Id.
We agree with the Examiner’s position. Appellants argue that,
because Bardsley teaches that the thin-walled section of its multiple-lumen
catheter is reinforced by the reinforcing member, the Examiner’s finding that
such a member could be combined with the teachings of Belson such that the
reinforcing member is associated with the thicker-walled member of Belson
(or with the catheter as a whole) is error. We disagree.
Belson teaches that:
The instrument is elongate and has a comparatively small
effective diameter, and in most embodiments, has a smaller
overall cross section area[,~\ than conventional instruments
adapted for the same purpose or task, for reasons set forth
below.... The instrument typically has a lumen extending
therethrough to support fiber optics, bending control
components, and other components, depending on such factors
as the degree of flexibility required, type of associated channel
release mechanism, the constitution material, and the like.
Belson | 54 (emphasis added). Belson thus expressly contemplates that its
instrument has a smaller diameter than comparable conventional instruments
and, further, teaches the addition of components to the instrument, including
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the non-expanding (i.e., thicker-walled) portion of the instrument, which
contains a lumen, depending upon the uses (e.g., requisite flexibility and the
constituent materials of the instrument.
Furthermore, Belson teaches:
A plurality of frame elements 1030 extend along the length of
the semi-tube 1020 and are enclosed by cover or sheath 1035
(FIGS. 10 and 11). The frame elements 1030 are flexible
structural elements that provide shape to the semi-tube structure.
The frame elements may be formed from any suitable metal or
plastic and sized depending upon the semi-tube application and
dimensions.
Belson 199. Belson thus directly suggests a reinforcement of the non-
expandable portion of its instrument that provide flexibility while maintain
the shape of the lumen. See also Belson Figs. 10, 11.
Bardsley teaches: “The catheter further has a reinforcing member
extending along the full length of at least one of the lumens, preferably the
reinforcing member is embedded in the septum.” Bardsley col. 2,11. 62—65.
Bardsley thus teaches that, contrary to Appellants’ assertions, the reinforcing
member is not necessarily limited to reinforcing the thin-walled lumen that
Appellants argue corresponds to their expandable second elongate member.
Bardsley also teaches:
The support member 135 may be of a variety of different
materials and configurations designed to impart the desired
stiffness to the catheter shaft section and in particular ensure that
the cross-sectional shape of the lumen remains substantially
undistorted as in undergoes the high flexure encountered during
traversal of the sharp bends in the vascular pathway. The
reinforcing and stiffening properties of the support member 135
allows the inner member to be extraordinarily thin walled and yet
maintain the integrity of the lumen cross-sectional shape.
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Bardsley col. 6,11. 14—23. In summary, Bardsley teaches that a support
member can be used in a catheter to decrease wall thickness (and hence,
cross sectional area) to provide reinforcement and stiffness to the inner
member, but also to the catheter shaft section, ensuring that the cross-
sectional shape of the lumen remains substantially undistorted.
We therefore agree with the Examiner’s conclusion that it would be
obvious to a person of ordinary skill to combine the teachings of Belson and
Bardsley quoted supra so as to impart to the thinner-than-usual device of
Belson the requisite stiffness and/or/flexibility taught by Bardsley, and as
suggested by Belson, while preventing undue distortion of the lumen of the
catheter.
Nor are we persuaded by Appellants’ argument that Bardsley teaches
away from Belson or Appellants’ claimed invention. An invention “teaches
away” when: “a person of ordinary skill, upon reading the reference, would
be discouraged from following the path set out in the reference, or would be
led in a direction divergent from the path that was taken by the applicant.”
In re Gurley, 27 F.3d 551, 553 (Fed.Cir. 1994). Appellants argue that
because the support member is taught by Bardsley as surrounding the thinner
walled lumen, Bardsley teaches away from combining this element with the
invention taught by Belson. See App. Br. 13—14. However, Appellants
point to no teaching of Bardsley, either express or implicit, nor can we
discern one, that would divert or discourage a person of ordinary skill from
combining the references. Furthermore, Belson directly invites such a
support member, teaching the addition of: “other components, depending on
such factors as the degree of flexibility required, type of associated channel
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release mechanism, the constitution material, and the like.” Belson H 54,
99. We are consequently not persuaded by Appellants upon this issue.
“Wherein a wall thickness of the second elongate member is at least 6 times
thinner than a wall thickness of the first elongate member such that the
second elongate member is cuttable.”
Appellants argue the Examiner concludes that, even though the
combined teachings of Belson and Bardsley are silent with respect to the
wall thickness of the first elongate member being at least six times thicker
than the wall thickness of the second elongate member, it would have been
obvious to one of skill in the art to provide such relative thicknesses since
discovering an optimum range or workable range of wall thicknesses
involves only routine skill in the art. App. Br. 15—16. Appellants point to
the Examiner’s citation of language from Bardsley to provide a rationale for
such relative thicknesses even though the teachings of Bardsley apply to
reinforcing an “extraordinarily thin walled” elongate member. Id. at 16.
According to Appellants, the Examiner concludes that a person skilled in the
art would discover an optimum range of relative thicknesses “to maintain its
cross-sectional shape during its intended use, provide an internal lumen
structure that does not inhibit free axial movement of any element positioned
therein, and yet maintain the desired flexibility, pushability and torqueability
required for its intended use.” Id. (quoting Final Act. 5).
However, Appellants argue, it is not just the wall thickness of the first
elongate member which provides the added functionality of Appellants’
claimed invention (i.e., collapsible, expandable, and cuttable), but rather the
relative wall thicknesses of the reinforced first elongate member between the
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second elongate member as recited in the claims. App. Br. 16. Appellants
argue, by way of example, that to provide for the cuttability of the less rigid
second elongate member while maintaining the rigidity of the first elongate
member (i.e., such that the first elongate member and the navigation tool are
not cut and the first and second elongate member can be removed from the
body while the lead remains positioned in the body), the relative rigidity
between the first and second elongate members is defined in the claims by
the wall thickness of the less rigid second elongate member specifically
being at least 6 times thinner than the wall thickness of the more rigid and
reinforced first elongate member. Id. at 16—17.
However, argue Appellants, Bardsley actually teaches away from
modifying the already thick first elongate member of Belson, as alleged by
the Examiner. App. Br. 17. Rather, Appellants assert, Bardsley describes
using reinforcement with the “extraordinarily thin walled” inner member
thereof. Id.
Appellants argue further that the claimed dimensional characteristics
actually provide an operation or functionality (e.g., relative cuttability of the
second elongate member) that is different than the functionality set forth by
the Examiner with reference to Belson and Bardsley (i.e., maintaining shape
to “provide an internal lumen structure that does not inhibit free axial
movement of any element positioned therein, and yet maintain the desired
flexibility, pushability and torqueability required for its intended use”). Id.
at 16. Appellants disagree with the Examiner’s conclusion that the fact that
Appellants have recognized another advantage which flows naturally from
following the suggestion of the prior art cannot be the basis for patentability
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when the differences would otherwise be obvious. Id. at 18. Appellants
point to the Examiner’s finding that although:
the prior art does not explicitly teach the same operation or
functionality of the claimed invention (e.g., allow cuttability of
the second elongate member relative to the first elongate member
so that the catheter may be removed while leaving the lead
positioned in the body), such a functionality would be capable of
being performed given the prior art teaches a second elongate
member that is constructed of a material that is fully capable of
being cut given enough force and a sharp enough object.
Id. (quoting Final Ac. 14).
However, Appellants assert, the Examiner cannot just ignore the
dimensional limitations and rely simply on the allegedly conclusory
statement that the meeting the dimensional characteristics are merely a
matter of discovering an optimum range or workable range of wall
thicknesses that involves only routine skill in the art. App. Br. 18. Rather,
Appellants contend, such dimensional characteristics (i.e., the relative
thickness of the first elongate member to the second provide a structure-
produced function unrecognized by the prior art cited by the Examiner. Id.
at 18—19. In other words, Appellants argue, a device having claimed
dimensional characteristics that allow the device to perform differently than
the prior art provides evidence of patentability. Id. at 19. As such,
Appellants argue, contrary to the Examiner’s findings, the claimed
dimensional characteristics actually provide for a different operation or
functionality of the claimed device (e.g., allowing cuttability of the second
elongate member) not set forth in the prior art. Id.
Appellants also note that the Examiner finds that whereas: “Belson
does not specifically recite the second elongate member being cuttable,
however, the mere recitation of a property that is inherently possessed by
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things in the prior art, does not cause a claim drawn to the recited property to
distinguish over the prior art” and that “Belson does teach a second elongate
member that is constructed of a material having thickness that is fully
capable of being cut given enough force and a sharp enough object.” App.
Br. 20 (quoting Final Act. 12).
Appellants consider the Examiner’s reliance on the alleged inherent
teachings of Belson misguided. App. Br. 20. According to Appellants, the
Examiner must provide a basis in fact and/or technical reasoning to
reasonably support the determination that the allegedly inherent
characteristic necessarily flows from the teachings of the applied prior art.
Id. Appellants argue that a prima facie case of inherency can be rebutted by
evidence showing that the prior art does not necessarily possess the
characteristics of the claimed limitations. Id. Appellants assert that there is
nothing in the cited references which would indicate that the second elongate
member of Belson is necessarily cuttable. Id. Appellants contend that
Belson’s second elongate member may, perhaps, be cuttable, but the fact
that the second elongate member of Belson may occur or be present in the
prior art is not sufficient to establish the inherency of that result or
characteristic. Id. (citing In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993).
The Examiner responds that, whereas Belson does not specifically
recite the second elongate member is cuttable, Belson does teach the
selectively collapsible and expandable second elongate member being made
of an elastomeric material that is known to be cuttable. Ans. 12 (citing
Belson | 59). The Examiner finds that, absent any recitation in the claims
that positively recites how the second elongate member is cuttable, the mere
recitation of a property that is inherently possessed by things in the prior art
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does not cause a claim drawn to the recited property to distinguish over the
prior art. Id. The Examiner finds that Belson does teach a second elongate
member that is constructed of a material having thickness that is fully
capable of being cut given a cutting member having an appropriate tensile
strength, sharpness, stiffness, and sufficient force to cut the material. Id.
The Examiner finds that the teaching of Bardsley relied upon by the
Examiner to support a rationale for optimizing the relative thickness of the
first and second elongate members was not solely directed to reinforcing the
extraordinarily thin walled elongate member. Ans. 13 (citing Bardsley col.
5,11. 7—15). Rather, the Examiner finds, this passage of Bardsley is relied
upon to support a rationale for optimizing the relative thickness of the first
and second elongate members. Id. Therefore, the Examiner finds, given
these teachings of Belson and Bardsley, it would have been obvious to one
of ordinary skill in the art to optimize the relative thickness of the first and
second elongate members such that the first elongate member was six times
thicker than the second elongate member in order to allow the lumen of the
first elongate member to maintain its cross-sectional shape during use while
maintain the desired flexibility pushability and torqueability of the first
elongate member and catheter shaft as a whole; and that allows the second
elongate member remain selectively collapsible and expandable. Id.
We are not persuaded by Appellants’ arguments. Belson teaches:
“[A]n apparatus having an instrument having an elongate body; and an
expandable lumen connected externally to the elongate body,... the
expandable lumen having a stowed configuration and a deployed
configuration.” Belson Abstr. (emphases added). Specifically, Belson
teaches: “[t]he diameter of the expandable lumen in the deployed
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configuration is adapted to deliver a device from a proximal opening in the
expandable lumen to a distal opening in the expandable lumen.” Belson | 6.
Belson further teaches that:
[T]he external channel [with the expandable lumen] is
formed from an elastomeric material that is a thermoplastic,
elastomeric material, such as polyurethane containing one or
more conventional slip agents, such as wax, oil, silicone or
silica.... The treated elastomeric material allows for small
diameter, thin-walled elastic medical components that can be
easily, inexpensively, and quickly manufactured. Similar
treatments may also be applied for ease of insertion of an
instrument. Also, in additional embodiments the elastic material
of the channel is made from an elastomeric material treated with
slip agents, the channel can be formed such that when in the
deployed configuration instruments are more readily inserted
into and advanced along the channel lumen.
Belson | 59. Similarly claim 1 recites:
[A] second elongate member that includes a second lumen
extending along a second longitudinal axis and configured to
receive the medical instrument, the second elongate member
being coupled directly to the first elongate member, the second
elongate member being in a normally collapsed state when the
first and second elongate members are positioned within the
body, wherein the second elongate member is expandable to
change a size of the second lumen.
In other words, the second elongate member of the claims and the external
channel of Belson, both of which are attached to a more rigid (i.e., non-
collapsible) first element, are designed to perform the same function, i.e.,
expand. See also Spec. 3 (“The second elongate member is also selectively
collapsible and expandable to change a size of the second lumen”).
Consequently, because the second elongate member of the claims and the
external channel of Belson are designed to perform the same functions, we
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agree with the Examiner that a person of ordinary skill in the art,
understanding the teachings of Belson, would routinely find it a matter of
routine design and optimization to achieve the dimensional requirements
recited in the claims (i.e., “at least 6 times thinner than a wall thickness of
the first elongate member”) (emphasis added).
Similarly, because Belson also teaches that the external channel is
expandable in the same manner as Appellants’ second elongate member and
is composed of an “elastomeric material” that permits the second elongate
member to be “small diameter, thin-walled[, and] elastic,” we similarly
agree with the Examiner that external channel of Belson would necessarily
be more “cuttable” than the more rigid, non-expandable instrument of
Belson. We note that Appellants place no qualifiers or limitations in the
language of the claim that define the term “cuttable” other than the relative
cuttability of the second elongate member with respect to the first elongate
member (i.e., “cuttable without cutting the first elongate member and the
navigation tool”). We agree with the Examiner that a person of ordinary
skill would understand that the expandable, thin-walled, small diameter, and
elastic material comprising the external channel of Belson would necessarily
be more “cuttable” than the more rigid, non-expandable, and thicker walled
material of the rest of the instrument.
Finally, Appellants argue that “a prima facie case of inherency can be
rebutted by evidence showing that the prior art does not necessarily possess
the characteristics of the claimed limitations.” App. Br. 20 (emphasis
omitted). However, Appellants point to no such evidence in either reference
that teaches or suggests that the thin walled, expandable and elastic material
of Belson’s external channel is not inherently more “cuttable” than the more
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rigid, non-expandable, and thicker walled material of the rest of the
instrument.
Consequently we affirm the Examiner’s rejection of the claims.
Furthermore, although Appellants argue claim 4 separately, they reply on
essentially the same arguments as argued supra. App. Br. 22—23. We
consequently affirm the Examiner’s rejection of claim 4.
DECISION
The Examiner’s rejection of claims 1,3, 5—13, and 20 as unpatentable
under 35 U.S.C. § 103(a) is 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)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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