Ex Parte Griswold et al

Patent Trial and Appeal Board

Feb 15, 2019

13482883 (P.T.A.B. Feb. 15, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/482,883 05/29/2012
80584 7590
Medtronic, Inc.
710 Medtronic Parkway
MS: LC340
Minneapolis, MN 55432
02/20/2019
FIRST NAMED INVENTOR
Erik C. Griswold
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.
P0041214.USU2/llll-384 3472
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
02/20/2019 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):
pairdocketing@ssiplaw.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 ERIK C. GRISWOLD, JAMES CAL VIN ALLAN,
RUDOLPH A. BEASLEY, WILLIAM J. HAVEL, JON D. SCHELL,
DON H. TRAN, and STEVEN L. WALDHAUSER
Appeal2018-006006
Application 13/482,883 1
Technology Center 3700
Before MICHAEL C. ASTORINO, BRADLEY B. BAY AT, and
TARA L. HUTCHINGS, Administrative Patent Judges.
ASTORINO, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), the Appellants appeal from the
Examiner's decision rejecting claims 1-22. We have jurisdiction over the
appeal under 35 U.S.C. § 6(b).
We REVERSE.
1 According to the Appellants, "[ t ]he Real Party in Interest is Medtronic, Inc.
of Minneapolis, Minnesota, the assignee of record, and Medtronic plc of
Dublin, Ireland, the ultimate parent entity of Medtronic, Inc." Appeal Br. 3.
Appeal2018-006006
Application 13/482,883
STATEMENT OF THE CASE
Subject Matter on Appeal
The technical field of the Appellants' invention "relates to delivery
and deployment techniques for implantable medical devices." Spec. ,r 2.
Claims 1 and 16 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the subject matter on appeal.
1. A kit for intravascular implantation of an implantable medical
device within a patient, the kit comprising:
an elongated outer sheath forming an inner lumen with a
distal opening and a proximal opening, the outer sheath sized to
traverse a vasculature of the patient;
an elongated inner sheath with a tapered distal end,
wherein the tapered distal end is configured to substantially fill
the inner lumen of the outer sheath and close-off the distal
opening of the outer sheath, wherein the inner sheath is slidable
within the inner lumen of the outer sheath, wherein the inner
sheath is selectably removable from the inner lumen of the outer
sheath by sliding the inner sheath out of the proximal opening of
the outer sheath; and
an elongated deployment receptacle including a
deployment bay at a distal end of the deployment receptacle and
a proximal portion, wherein the deployment receptacle is slidable
within the inner lumen of the outer sheath when the inner sheath
is not within the inner lumen of the outer sheath, wherein the
deployment bay is configured to carry the implantable medical
device through the inner lumen of the outer sheath and facilitate
deployment of the implantable medical device out of the distal
opening of the outer sheath, wherein the deployment bay
includes a proximal wall that limits proximal movement of the
implantable medical device relative to the elongated deployment
receptacle while the implantable medical device is carried within
the deployment bay, wherein a transverse cross section of the
proximal portion is smaller than a transverse cross section of the
deployment bay.
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Application 13/482,883
Rejections
The Examiner maintains the following rejections under (pre-AIA)
35 U.S.C. § I03(a):
claims 1-3 and 9 as unpatentable over Boyle '902 2,
Boyle '537 3, and Zhang4; 5
claims 4 and 5 as unpatentable over Boyle '902, Boyle '537,
Zhang, and Rafiee6;
claims 6-8 as unpatentable over Boyle '902, Boyle '537,
Zhang, and Benjamin 7;
claims 10, 14, and 15 as unpatentable over Boyle '902,
Boyle '537, Zhang, and Griswold8;
claim 10 as unpatentable over Boyle '902, Boyle '537, Zhang,
and Jacobson9;
claims 11-13 as unpatentable over Boyle '902, Boyle '537,
Zhang, and VanTassel 10 ;
2 Boyle et al. (US 6,679,902 Bl, iss. Jan. 20, 2004) ("Boyle '902").
3 Boyle et al. (US 2003/0004537 Al, pub. Jan. 2, 2003) ("Boyle '537").
4 Zhang et al. (US 6,120,480, iss. Sept. 19, 2000) ("Zhang").
5 In the Final Office Action, the Examiner twice addresses claim 17 as
unpatentable over Boyle '902, Boyle '537, and Zhang. Final Act. 3, 19; see
Appeal Br. 6, n.48 ( acknowledging "there does not appear to be any
differences between these two rejections"). In the Answer, the Examiner
addresses claim 17 once. Ans. 14. We follow the Examiner's approach in
the Answer.
6 Rafiee et al. (US 2009/0192601 Al, pub. July 30, 2009) ("Rafiee").
7 Benjamin et al. (US 2010/0004730 Al, pub. Jan. 7, 2010) ("Benjamin").
8 Griswold et al. (US 2011/0251662 Al, pub. Oct. 13, 2011) ("Griswold").
9 Jacobson (US 2007/0088418 Al, pub. Apr. 19, 2007).
10 VanTassel et al. (US 6,645,143 B2, iss. Nov. 11, 2003) ("VanTassel").
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Application 13/482,883
claims 14 and 15 as unpatentable over Boyle '902, Boyle '537,
Zhang, and Altman 11 ;
claims 16 and 18 as unpatentable over Boyle '902 and
Boyle '537;
claim 17 as unpatentable over Boyle '902, Boyle '537, and
Zhang;
claims 19 and 20 as unpatentable over Boyle '902, Boyle '537,
and VanTassel;
claims 21 and 22 as unpatentable over Boyle '902, Boyle '537,
and Griswold; and
claims 21 and 22 as unpatentable over Boyle '902, Boyle '537,
and Jacobson.
ANALYSIS
Independent Claim 1 and Dependent Claims 2-15
Independent claim 1 calls for a kit comprising an elongated
deployment receptacle including a deployment bay at a distal end and a
proximal portion, "wherein a transverse cross section of the proximal portion
is smaller than a transverse cross section of the deployment bay." Appeal
Br., Claims App.
The Examiner finds that Boyle '902 teaches a low profile delivery
sheath having a proximal portion and a deployment bay at a distal end. Final
Act. 3--4. As for the latter, the Examiner specifically finds that the
deployment bay reads on "necked down section 44 and/or bearing surface 54
11 Altman (US 2002/0120250 Al, pub. Aug. 29, 2002).
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Application 13/482,883
of the cylindrical cavity 50." Id.; see Boyle '902, col. 5, 11. 14--23, 47-55.
The Examiner finds that Boyle '902 fails to "teach a transverse cross section
of the proximal portion is smaller than a transverse cross section of the
deployment bay." Final Act. 4. Indeed, the transverse cross section of
Boyle '902's proximal portion is larger than a transverse cross section of the
deployment bay. See Boyle '902, Figs. 1, 4.
To remedy this deficiency, the Examiner turns to the teachings of
Boyle '537. 12 Final Act. 4. The Examiner finds that Boyle '537 teaches a
sheath where a transverse cross section of tubular member 7 4 is smaller than
a transverse cross section than housing portion 62. See id. ( citing
Boyle '537, Figs. 4--5).
The Examiner determines that it would have been obvious to one of
ordinary skill in the art to modify the proximal portion of Boyle '902's
sheath to have a smaller transverse cross section than the deployment bay, as
taught by Boyle '537. See id. at 4--5. The Examiner explains this
modification to be "a simple substitution of one known, sufficiently pushable
proximal portion of a delivery sheath for another to yield no more than
predictable results." Ans. 3 (emphasis added). 13 Further, the Examiner
explains that proposed substitution is not to make the deployment bay at the
distal end of the Boyle '902's sheath larger. See id. at 6.
12 The Examiner does not rely on Zhang's teachings to further modify
Boyle '902's sheath to meet the claimed subject matter particular to the
elongated deployment receptacle. See Final Act. 5---6.
13 The Examiner withdrew "the alternate rejection based on the smaller
diameter proximal portion being a mere matter of design choice." Ans. 6;
see Final Act. 5.
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The basis for the Examiner's simple substitution is that the relative
size of the proximal and distal portions of Boyle '902's sheath may be
swapped because a change in elasticity of the material presumably would
maintain the required stiffness for pushability. See id. at 3. In support of
this substitution, the Examiner finds that Boyle '902's sheath requires a
proximal portion that is "sufficiently stiff to provide good pushability within
a guiding catheter" and that Boyle '537's sheath teaches a proximal portion
that is similar in that it provides "a sufficiently high column strength." Id. at
2-3; see Boyle '902, col. 3, 11. 27-37; Boyle '537 ,r,r 19, 56.
The Appellants argue, among other things, that the Examiner fails to
show that substituting the material and transverse cross section of the
proximal portion of Boyle '537's sheath for the material and transverse cross
section of the proximal portion of Boyle '902's sheath would be adequate to
maintain the required pushability for Boyle '902 sheath. See Reply Br. 7-
13. The Appellants' argument is persuasive.
The Examiner presumes that the stiffness for the proximal portion of
Boyle '537's sheath is acceptable for the proximal portion of Boyle '902's
sheath. See Ans. 3. However, the Examiner's presumption appears to be
based more on speculation than being adequately supported by evidence and
technical reasoning. For example, the Examiner fails to compare the
stiffness (i.e., elasticity) of the materials for the proximal portions of
Boyle '902's and Boyle '537's sheaths. As pointed out by the Appellants:
the proximal portion of Boyle '902's sheath may be made of
any suitable bio-compatible polymer possessing a relatively high
modulus of elasticity, e.g., high density polyethylene (HDPE), high
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density polypropylene, PeBax 72D (Reply Br. 7, n.2 ( citing
Boyle '902, col. 5, 11. 7-11 ), n.4);
the distal portion of Boyle '902's sheath includes a material
having a low modulus of elasticity, e.g., PeBax 40b and polyolefin (id.
at 7, n.5 ( citing Boyle '902, col. 5, 1. 66 - col. 6, 1. 8));
the proximal portion of Boyle '537's sheath is made of low
elastic material, e.g., PeBax 40D, cross-linked HDPE, polyolefin,
polyamide (id. at 7, n.3 (citing Boyle '537 i-f 51); see Boyle '537 i-f 56);
and
the material of the distal portion of Boyle '902's sheath and the
proximal portion of Boyle '537's sheath is not a relatively high
modulus of elasticity (see Reply Br. 7-8).
On this record, the Examiner's substitution fails to recognize that the
proposed change in material for the proximal portion of Boyle '902's sheath
is to a material that lacks a relatively high modulus of elasticity. And, the
Examiner fails to adequately show how a change in material for the
proximal portion of Boyle '902's sheath to have a low elastic material
would have resulted in the required pushability for Boyle '902 sheath.
Further, the Examiner fails to adequately analogize how the elasticity or
stiffness of the materials for the proximal portions of Boyle '902's and
Boyle '537's sheaths relates to: the elasticity or stiffness of the distal
portions of Boyle '902's and Boyle '537's sheaths; the actual dimensions of
the proximal and distal portions of Boyle '902's and Boyle '537's sheaths;
and functions of Boyle '902's and Boyle '537's sheaths generally, and/or the
proximal and distal portions, specifically. See id. at 7-13; see, e.g.,
7
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Boyle '902, col. 4, 1. 64- col. 5, 1. 7 (suggesting relative size of the proximal
portion's wall thickness and lumen affects good pushability).
Thus, we do not sustain the Examiner's rejection of independent
claim 1 as unpatentable over Boyle '902, Boyle '537, and Zhang. The
Examiner does not rely on the art of record in a manner that cures the
deficiency in the rejection of claim 1 discussed above. Accordingly, on the
record before us, we also do not sustain the rejections of claims 2-15, which
depend either directly or indirectly from independent claim 1.
Independent Claim 16 and Dependent Claims 17-22
Independent claim 16 recites "[a] method for intra vascular
implantation of an implantable medical device within a patient" that includes
a step of "inserting an elongated deployment receptacle, including a
deployment bay at a distal end of the deployment receptacle and a proximal
portion, ... wherein a transverse cross section of the proximal portion is
smaller than a transverse cross section of the deployment bay." Appeal Br.,
Claims App.
The Examiner's rejection of claim 16 is based on the same
inadequately supported findings and reasoning discussed above with regard
to the rejection of claim 1. See Final Act. 18-19; Ans. 3, 6.
Thus, we do not sustain the Examiner's rejection of independent
claim 16 as unpatentable over Boyle '902 and Boyle '537. The Examiner
does not rely on the art of record in a manner that cures the deficiency in the
rejection of claim 16. Accordingly, on the record before us, we also do not
sustain the rejections of claims 17-22, which depend either directly or
indirectly from independent claim 16.
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DECISION
We REVERSE the Examiner's decision rejecting claims 1-22.
REVERSED
9