Ex Parte Spear et al

Patent Trial and Appeal Board

Dec 26, 2018

14283303 (P.T.A.B. Dec. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/283,303 05/21/2014
27581 7590 12/28/2018
Medtronic, Inc. (CVG)
8200 Coral Sea Street NE.
MS:MVC22
MINNEAPOLIS, MN 55112
FIRST NAMED INVENTOR
Stanten C. Spear
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.
P010017.USC23/LG10126.L33 6784
EXAMINER
PEFFLEY, MICHAEL F
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
12/28/2018 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.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STANTEN C. SPEAR,
JAMES F. KELLEY, KENNETH C. GARDESKI,
MOHMOUD K. SERAJ, and ERIC K.Y. CHAN
Appeal2017-010215
Application 14/283,303
Technology Center 3700
Before ERIC B. GRIMES, JEFFREY N. FRED MAN, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134(a) involving claims to a
system for positioning implantable medical devices within the coronary
sinus. The Examiner rejected the claims as obvious. We have jurisdiction
under 35 U.S.C. § 6(b ). We affirm.
1 Appellants identify the Real Party in Interest as Medtronic, Inc. and
Medtronic plc. (Br. 2).
2 We have considered and herein refer to the Specification of May 21, 2014
("Spec."); Final Office Action of Dec. 7, 2016 ("Final Action"); Appeal
Brief of Apr. 6, 2017 ("Br."); and Examiner's Answer of May 17, 2017
("Ans.").
Appeal2017-010215
Application 14/283,303
Statement of the Case
Background
"In treating conditions such as arrhythmia, one technique is to destroy
or damage heart tissue that causes or is involved with the arrhythmia by
suitably heating the tissue" (Spec. 1: 17-19). "If the site is not accurately
mapped, much of the viable tissue surrounding the site will be unnecessarily
destroyed" (id. at 1:29-31 ). "To determine the location of the tissue to be
ablated, it is widely known to use elongated intravascular signal sensing
devices that are advanced through the patient's vasculature" (id. at 2: 1-3).
"[I]t remains quite difficult to accurately and reliably contact the various
curved shapes one encounters in the endocardial lining. This is due to the
frequent inability to customize the shape of their distal portion" (id. at 2:23-
26).
The Claims
Claims 1, 2, 8-10, 38--43, 45, and 46 are on appeal. Claim 1 is
representative and reads as follows:
1. A system for positioning implantable medical devices
within the coronary sinus or a branch vein thereof, comprising:
a substantially straight slittable sheath having an inner
lumen, a shaft section, and a distal section that is distal to, and
softer than, the shaft section, the sheath further including a
slittable braid adjacent to at least a portion of at least one of the
shaft section and the distal section, wherein the braid is formed
of stainless steel, wherein the braid has an ultimate tensile
strength of between approximately 200 and 250 kilo-pounds per
square inch (ksi), wherein the braid has a pie count of between
35 and 55 pies per inch, and further wherein the braid is formed
of a wire having a diameter of approximately 0.002 inches; and
a steerable catheter having a shaft adapted to be inserted
within the inner lumen of the sheath.
2
Appeal2017-010215
Application 14/283,303
The Rejections
A. The Examiner rejected claims 1, 2, 8-10, 38--43, 45, and 46 on the
ground ofnonstatutory double patenting over claims 1-16 of US 7,497,844
(Final Act. 7).
B. The Examiner rejected claims 1, 2, 8-10, 38--43, 45, and 46 on the
ground of nonstatutory double patenting over claims 1-24 of US 8,734,397
(Final Act. 8).
C. The Examiner rejected claims 1 and 2 under 35 U.S.C. § 103(a) as
obvious over Randolph3 and Mirarchi4 (Final Act. 2-3).
D. The Examiner rejected claims 8-10 under 35 U.S.C. § 103(a) as
obvious over Randolph, Mirarchi, and Badger5 (Final Act. 3--4).
E. The Examiner rejected claims 38--42 under 35 U.S.C. § 103(a) as
obvious over Randolph and Badger (Final Act. 4--5).
F. The Examiner rejected claim 43 under 35 U.S.C. § 103(a) as obvious
over Randolph, Badger, and Ressemann6 (Final Act. 5---6).
G. The Examiner rejected claims 7 45 and 46 under 35 U.S.C. § 103(a) as
obvious over Randolph, Badger, 8 and Ressemann (Final Act. 6).
3 Randolph et al., US 5,775,327, issued July 7, 1998.
4 Mirarchi et al., US 5,562,619, issued Oct. 8, 1996.
5 Badger et al., US 4,898,577, issued Feb. 6, 1990.
6 Ressemann et al., US 5,501,694, issued Mar. 26, 1996.
7 The rejection included claims 44, 47, and 48, but these claims were
cancelled in Appellants Amendment filed Oct. 16, 2016. We therefore do
not address them.
8 We note that the Examiner inadvertently omitted Badger from the
statement of the rejection, but relies upon Badger in the body of the rejection
(see Final Act. 6). We therefore treat this rejection as also relying on
Badger.
3
Appeal2017-010215
Application 14/283,303
A. &B. Obviousness-Type Double Patenting
Appellants do not dispute the rejection of the claims under
obviousness-type double patenting rejections on the merits (see Br. 2).
We therefore summarily affirm the obviousness-type double patenting
rejection over US 7,497,844 and US 8,734,397. See Manual of Patent
Examining Procedure§ 1205.02 ("If a ground of rejection stated by the
examiner is not addressed in the appellant's brief, that ground of
rejection will be summarily sustained by the Board.")
C. 35 US.C. § 103(a) over Randolph and Mirarchi
The Examiner finds Randolph teaches "an implantable device (70)
within a coronary sinus comprising a substantially straight, slittable sheath
(10) having an inner lumen (14) and having a distal section (18) that is softer
than a shaft section (17) and having a slittable braid (61)." (Final Act. 2).
The Examiner finds "any braid is 'slittable"' (id.). The Examiner also finds
"the diameter, pie count and tensile strength of a reinforcing braid would be
obvious design considerations for one of ordinary skill in the art" (id.).
The Examiner acknowledges that while Randolph teaches a catheter
"inserted within the inner lumen of the sheath," Randolph "fails to
specifically disclose the catheter is steerable" (Final Act. 2).
The Examiner finds Mirarchi teaches "an EP catheter (32) that is
inserted through a sheath (30). In particular, Mirarchi et al disclose the
catheter is steerable to reach a desired tissue location relative to the sheath"
(Final Act. 3).
The Examiner finds it would have been obvious to modify Randolph
"with a steerable EP catheter to control the deflection of the catheter"
4
Appeal2017-010215
Application 14/283,303
because Mirarchi teaches "it is known to provide an EP catheter that is
introduced through a sheath with a steering means" (Final Act. 5).
The issue with respect to this rejection is: Does a preponderance of the
evidence of record support the Examiner's conclusion that the prior art
renders claim 1 obvious?
Findings of Fact (FF)
1. Randolph teaches "a guiding catheter for the direction of an
intravascular device into a patient's coronary sinus" (Randolph 1:8-10).
2. Figure 1 of Randolph is reproduced below:
Figure 1 illustrates a catheter 10 that includes "an elongated shaft 11, a distal
shaft section 12, a proximal shaft section 13, an inner lumen 14 and an
adapter 15 on the proximal end of the shaft 11" (Randolph 3:64---66).
3. Randolph teaches an embodiment of the catheter in which "the
proximal portion of the catheter shaft 60[, which is shaft section 13 in Figure
1,] has braided reinforcement 61 to provide increased torquability"
(Randolph 4:43--44).
4. Mirarchi teaches "an axially elongated steerable catheter of the
type having a distal tip portion deflectable in a plane in response to a pull
wire within the catheter and capable of being torqued at its proximal portion
5
Appeal2017-010215
Application 14/283,303
to change the rotational orientation of the tip portion about the longitudinal
axis" (Mirarchi 1 :49--54).
5. Mirarchi teaches
the catheter body 30 includes a stainless steel braid of counter-
wound double wires with a pick count (i.e., the number of times
that wires cross a unit of tube length) of about 32-34 times per
inch. The stainless steel wires are braided over a polyurethane
tube which is subsequently over-extruded with a polyurethane
coating that bonds through the braid to the inner tubing to form
a unitary structure with a hardness of about D70.
(Mirarchi 5:27-34).
6. Mirarchi teaches the steerable catheter "permits a surgeon to
precisely control the position of the catheter tip during advancement of the
catheter through a body lumen, during a surgical procedure, such as
electrophysiological mapping or ablation of heart tissue ... without risk of
puncture to the patient's vessels" (Mirarchi 2:14--18).
Principles of Law
A prima facie case for obviousness "requires a suggestion of all
limitations in a claim," CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and "a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
Appellants contend that:
Contrary to the Examiner's assertions, the specific claimed
construction of the slittable braid is not just a matter of design
choice to provide certain characteristics. Rather, such
construction actually provides very beneficial functionality
6
Appeal2017-010215
Application 14/283,303
(e.g., slittable, yet provides support and kink resistance all the
way to the tip of the slittable sheath).
(Br. 7). Appellants further contend "the Examiner cannot just ignore such
construction limitations and rely simply on the conclusory statement that the
construction characteristics are merely a matter of design choice and allege
that such construction would be recognized as being within the level of
ordinary skill in the art" (id. at 8).
The Examiner acknowledges that Mirarchi fails "to expressly disclose
the diameter of the braid, or the specific ultimate tensile strength of the
braid" (Ans. 3). 9 However, the Examiner
maintains that the diameter for reinforcing braid fibers are
generally well within the purview of the skilled artisan. That is,
those of ordinary skill in the art would readily recognize
acceptable diameter ranges for a reinforcing fiber. The fact that
the prior art in general does not disclose such parameters is, in
the examiner's position, evidence that the size limitations are
generally known given the size of the catheters and the desired
flexibility. It is also the examiner's position that applicant has
not afforded any criticality or unexpected results associated
with the claimed parameter ranges. That there may be
beneficial functional attributes to these parameters is merely an
optimization of characteristics.
(Ans. 4).
9 We note that the Examiner reasonably relies on Mirarchi' s teaching of a
pick count of about 32-34 times per inch (FF 5) to render obvious the claim
requirement that the braid has a pick count of "between 3 5 and 5 5 pies per
inch." See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) ("We have
also held that a prima facie case of obviousness exists when the claimed
range and the prior art range do not overlap but are close enough such that
one skilled in the art would have expected them to have the same
properties.")
7
Appeal2017-010215
Application 14/283,303
We agree with Appellants that the Examiner must provide evidence or
sound reasoning in order to demonstrate the obviousness of particular claim
limitations such as "an ultimate tensile strength of between 200 and 250
kilo-pounds per square inch" and "formed of a wire having a diameter of
approximately 0.002 inches" as recited in claim 1. See In re Van Os, 844
F.3d 1359, 1361 (Fed. Cir. 2017). ("Absent some articulated rationale, a
finding that a combination of prior art would have been 'common sense' or
'intuitive' is no different than merely stating the combination 'would have
been obvious."').
In this case, the Examiner does not provide the necessary evidence or
sound reasoning supporting a finding of obviousness. While Mirarchi
teaches the use of stainless steel wires (FF 5), the same material as used in
the Specification (see Spec. 16: 14), the Examiner does not provide evidence
that the stainless steel wires of Mirarchi necessarily and inherently have the
tensile strength or diameter required by claim 1. Nor does the Examiner
provide any reasoning explaining why it would have been obvious to select
stainless steel wires with the required tensile strength or diameter other than
assertions of "design choice" and "optimization". Our reviewing court has
required that "the Board must provide some rational underpinning
explaining why a person of ordinary skill in the art would have arrived at the
claimed invention through routine optimization." In re Stepan Company,
868 F.3d 1342, 1346 (Fed. Cir. 2017).
The Examiner provides no such rational underpinning demonstrating
that the prior art recognized tensile strength of wires or wire diameters in
this context as optimizable variables. And "a change to a parameter may be
patentable if the parameter was not recognized as 'result-effective."' E.I.
8
Appeal2017-010215
Application 14/283,303
DuPont de Nemours & Co., v. Synvina C. V., 904 F.3d 996, 1006 (Fed. Cir.
2018)(citing In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir.
2012). Therefore, the evidence of record is insufficient to support a finding
that either of the parameters of the wire, tensile strength or diameter, are
result effective and optimizable variables.
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner's conclusion that the prior art renders claim 1 obvious.
D. 35 US.C. § 103(a) over Randolph, Mirarchi, and Badger
Having reversed the obviousness rejection of claim 1 over Randolph
and Mirarchi for failing to render the tensile strength or diameter limitations
obvious for the reasons given above, we also find that the further
combination with Badger does not render dependent claims 8-10 obvious
for the same reasons.
E. 35 US.C. § 103(a) over Randolph and Badger
The Examiner finds Randolph teaches "a sheath for receiving a
catheter comprising a shaft section (13) and a distal section (17) including a
soft tip ( 18) extending from a transition" (Final Act. 4 ). The Examiner finds
Randolph teaches a "slittable braid ( 61) extends along a shaft section" (id.).
The Examiner finds Randolph teaches "an inner lumen (14)" but
acknowledges that Randolph "fails to expressly disclose an internal liner
disposed along the shaft section" (id.).
The Examiner finds Badger teaches "it is advantageous to provide a
lubricious liner for the inner lumen to facilitate passage of devices through
9
Appeal2017-010215
Application 14/283,303
the lumen" (Final Act. 4 ). The Examiner finds that the "specific length of
the liner would be an obvious design consideration for one of ordinary skill
in the art to provide the desired lumen characteristics" (id. at 4--5).
The issue with respect to this rejection is: Does a preponderance of the
evidence of record support the Examiner's conclusion that the prior art
renders claim 38 obvious?
Findings of Fact (FF)
7. Figure 1 of Badger is reproduced below:
"-15
"Figure 1 illustrates a guiding catheter 10" that "comprises an elongated
tubular member 11 with a proximal portion 12 and a distal portion 13. A first
relatively large diameter longitudinally extending lumen 14 and a second
relatively small diameter longitudinally extending lumen 15 are provided in
tubular member 11" (Badger 3:29--35).
8. Badger teaches that "[l]umen 15 is of smaller diameter than
lumen 14 and has disposed therein a control line 16 which is fixed to the
distal tip 17 by adhesive 18" (Badger 3:38--40).
10
Appeal2017-010215
Application 14/283,303
9. Badger teaches "[ t ]he large lumen 14 is formed with a liner 26
of lubricious material such as polytetrafluoroethylene (Teflon) which is
positioned eccentrically within the tubular sheath 25" (Badger 4: 12-15).
Principles of Law
"If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability." KSR, 550 U.S. at 417.
Analysis
Appellants contend "even if Randolph et al. describes a braided
reinforcement and Badger et al. describes a liner, nothing in the references
describe the configuration of the liner, braid, and soft tip of the distal section
as described in claim 3 8" (Br. 11 ). Appellants contend Randolph
does not teach or suggest a braid that is terminated at
approximately a transition location as described in claim 3 8
(e.g., the transition location being where the soft tip starts and
then extends to the distal end of a slittable sheath). For
example, as described in column 4, lines 42--48, of Randolph et
al., braided reinforcement is provided in the proximal portion
and not towards the distal end of the device.
(Id.) Appellants contend Badger "does not teach or suggest that the internal
liner terminates within the distal section of the sheath beyond the distal end
of the slittable braid" (id.).
The Examiner responds that Randolph teaches "a proximal braid that
is located in a proximal portion of the catheter. That is, it does not extend to
the more flexible distal tip" (Ans. 6). The Examiner contends "[t]here is no
clear definition in the claims for what is a 'distal section', and that any
portion where the braid ends in the Randolph et al device may be considered
a 'transition location"' (id.). The Examiner also finds that Badger teaches
11
Appeal2017-010215
Application 14/283,303
(Id.)
a liner that extends to the end of the device. Providing such a
liner in the Randolph et al lumen would result in a liner that
extends to the distal end of the device, which would mean
terminating within the distal section (i.e. distal tip) beyond the
distal end of the braid.
During prosecution, we give claim terms the broadest reasonable
interpretation as understood by a person of ordinary skill in the art in light of
the specification. In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997); In re
Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004)
("Construing claims broadly during prosecution is not unfair to the applicant
... because the applicant has the opportunity to amend the claims to obtain
more precise claim coverage.")
Claim 38
On the record before us, we agree with the Examiner. The
Specification does not define the terms "distal" or "proximal" but rather
orients these locations relative to one another, stating the sheath "comprises
a distal end 112, a distal section 110, and a proximal section 120, each of
which comprises a polymeric jacket material having differing flexibilities"
(Spec. 9:28-30). Thus, without specific defined locations, the terms "distal"
and "proximal" represent the relative position of the soft tip, the slittable
braid, and the internal liner.
As the Examiner correctly notes, Randolph teaches a sheath with a
shaft, distal section, and a "slittable" braid 10 (FF 2-3). Randolph
10 We agree with the Examiner that the term "slittable" represents a
functional recitation that imposes no particular structure on the braid other
than the capacity to be slit. Schreiber teaches that writing a claim that mixes
12
Appeal2017-010215
Application 14/283,303
specifically locates the braid proximally on the catheter, teaching "the
proximal portion of the catheter shaft 60 has braided reinforcement 61 to
provide increased torquability" (FF 3). Thus, Randolph directly suggests
placement of the reinforcement braid on the proximal portion of the catheter.
Badger discloses an internal liner 26 for a catheter that forms a large
lumen 14 (FF 9). Badger discloses that lumen 14 extends the entire length
of the catheter, from the proximal to the distal end (FF 7). The Examiner
reasonably finds it would have been obvious to include Badger's liner 14 in
the catheter of Randolph because the ordinary artisan would have found it
obvious that the lubricious liner would "facilitate passage of devices through
the lumen" (Final Act. 4 ). Because these devices pass through the entire
catheter, the ordinary artisan would have found it obvious to use an internal
liner as in Badger through the entirety of Randolph's catheter as shown in
Badger (FF 7), not simply one portion, for the reason given by the Examiner.
Because the braid will terminate prior to the distal end of the catheter
(FF 3), and the internal liner will extend all the way to the distal end of the
catheter, the braid will necessarily distally terminate at a point beyond that at
which the distal end of the slittable braid terminates (FF 7, 9).
structural and functional limitations comes at a price. In re Schreiber, 128
F.3d 1473, 1478 (Fed. Cir. 1997). ("[C]hoosing to define an element
functionally, i.e., by what it does, carries with it a risk."). The price is that
when the Examiner "has reason to believe" that the prior art reference
inherently teaches the functional limitation, the burden shifts to the patent
applicant to show that the functional limitation cannot be met by the single
prior art reference. Id. See also In re Best, 562 F.2d 1252, 1254--55 (CCPA
1977).
13
Appeal2017-010215
Application 14/283,303
Therefore, the catheter suggested by Randolph and Badger would
have reasonably comprised a slittable braid that extends along the proximal
portion of the shaft to a distal location short of the distal end of the catheter
(FF 3) as well as an internal liner extending through the entire catheter that
therefore necessarily distally terminates beyond the distal end of the slittable
braid (FF 7, 9).
Claim 39
We separately address claim 39 because this claim includes the tensile
strength limitation recited in claim 1. For the reasons given above with
respect to claim 1, we find that Randolph and Badger do not suggest or
render obvious the tensile strength limitation of claim 39.
Conclusion of Law
A preponderance of the evidence of record supports the Examiner's
conclusion that the prior art renders claim 3 8 obvious.
A preponderance of the evidence of record does not support the
Examiner's conclusion that the prior art renders claim 39 obvious.
F. and G. 35 US.C. § 103(a) over Randolph, Ressemann, and Badger
Appellants do not separately argue the limitations of claims 43, 45,
and 46. Having affirmed the obviousness rejection of claim 3 8 over
Randolph and Badger for the reasons given above, we also find that the
further combinations with Ressemann renders these dependent claims
obvious for the reasons given by the Examiner (see Final Act 5---6).
14
Appeal2017-010215
Application 14/283,303
SUMMARY
In summary, we affirm the rejection of claims 1, 2, 8-10, 38--43, 45,
and 46 on the ground of nonstatutory double patenting over claims 1-16 of
us 7,497,844.
We affirm the rejection of claims 1, 2, 8-10, 38--43, 45, and 46 on the
ground ofnonstatutory double patenting over claims 1-24 of US 8,734,397.
We reverse the rejection of claims 1 and 2 under 35 U.S.C. § 103(a)
as obvious over Randolph and Mirarchi.
We reverse the rejection of claims 8-10 under 35 U.S.C. § 103(a) as
obvious over Randolph, Mirarchi, and Badger.
We affirm the rejection of claim 38 under 35 U.S.C. § 103(a) as
obvious over Randolph and Badger. Claims 40--42 fall with claim 3 8.
We reverse the rejection of claim 39 under 35 U.S.C. § 103(a) as
obvious over Randolph and Badger.
We affirm the rejection of claim 43 under 35 U.S.C. § 103(a) as
obvious over Randolph, Badger, and Ressemann.
We affirm the rejection of claims 45 and 46 under 35 U.S.C. § 103(a)
as obvious over Randolph, Badger, and Ressemann.
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
15