Ex Parte Baudino

Patent Trial and Appeal Board

Jun 15, 2018

13749489 (P.T.A.B. Jun. 15, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/749,489 01/24/2013
64619 7590 06/19/2018
MEDTRONIC, INC. (NEURO/MRG)
710 MEDTRONIC PARKWAY NE
MS-LC340
MINNEAPOLIS, MN 55432-5604
FIRST NAMED INVENTOR
Michael D. Baudino
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.
P0038473.USU2
(134.054301
CONFIRMATION NO.
4512
EXAMINER
PHAM, MINH DUC GIA
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
06/19/2018 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):
ptodocketing@mrgs.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte MICHAEL D. BANDIN0 1
Appeal2017-006866
Application 13/749,489
Technology Center 3700
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and JOHN E.
SCHNEIDER, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to an implantable medical lead.
The Examiner rejected the claims as anticipated under 35 U.S.C. § 102 and
obvious under 35 U.S.C. § 103. Appellant appeals the rejections pursuant to
35 U.S.C. § 134. We have jurisdiction under 35 U.S.C. § 6(b). The
rejections are affirmed, but because the reasoning differs from the
Examiner's, the affirmances are designated as new grounds of rejection
under 37 C.F.R. § 41.50(b).
1 The Appeal Brief ("Appeal Br.") 3 lists Medtronic, Inc. of Minneapolis,
Minnesota, the assignee of record, and Medtronic plc of Dublin, Ireland, the
ultimate parent entity of Medtronic, Inc. as the real-parties-in-interest.
Appeal2017-006866
Application 13/749,489
STATEMENT OF THE CASE
The claims are directed to an implantable medical lead. The leads are
capable of delivering electrical signals to the tissue of a patient, such as a
nerve. Spec. 1:4--5. The Specification teaches:
Leads are typically implanted through the use of an introducer
and stylet. The introducer is used to tunnel a subcutaneous path
from the site implantation of the IPG [implantable pulse
generator] to, or near, the target site. The lead is then passed
through a lumen of the introducer, and thus through the
subcutaneous path. A sty let may be inserted into a lumen of the
lead to push the lead through the lumen of the introducer. The
stylet is removed and the introducer is withdrawn over the lead.
The lead implantation procedure can be time consuming and
. .
mvas1ve.
Spec. 1: 1 7-23.
Claims 1-17 and 21 stand rejected by the Examiner as follows:
1. Claims 1, 2, 10, and 15 under pre-AIA 35 U.S.C. § I02(b) as
anticipated by U.S. Pat. No. 7,146,222 B2 (issued Dec. 5, 2006) to Boling
("Boling").
2. Claim 1, 2, 6, 9-17, and2I underpre-AIA35 U.S.C. § I03(a) as
obvious U.S. Pat. Appl. Publ. No. 2005/0209667 Al (published Sep. 22,
2006) ("Erickson") and U.S. Pat. Appl. Publ. No. 2011/0054581 Al
(published Mar. 3, 2011) (Desai").
3. Claims 3-5, 7, and 8 under pre-AIA 35 U.S.C. § I03(a) as obvious
in view of Erickson, Desai, and U.S. Pat. Appl. Publ. No. 2006/0247749 Al
(published Nov. 2, 2006) ("Colvin").
Claim 1, the only independent claim on appeal, is reproduced below:
1. An implantable medical lead comprising:
a proximal end portion including a plurality of contacts
and having a proximal end; and
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Application 13/749,489
a distal end portion including an array of electrodes and
having a distal end for tunneling and a generally flat body
extending proximally from the distal end, each of the electrodes
of the array being discretely electrically coupled to one of the
plurality of contacts and the array of electrodes being exposed
through a surface of the generally flat body along an array
length,
wherein the body of the distal end portion is sufficiently
stiff to be pushed through subcutaneous tissue without use of an
introducer.
REJECTION BASED ON BOLING
The Examiner cited Figures 9 and 14 of Boling as showing an
implantable medical lead with all the limitations recited in the claim. Final
Act 3. For the recited limitation of "the body of the distal end portion is
sufficiently stiff to be pushed through subcutaneous tissue without use of an
introducer," the Examiner identified the teaching in Boling at column 19,
lines 3-14 of a stylet. Final Act. 4.
Appellant does not dispute that the lead described in Boling has the
claimed electrodes and contacts as required by the claim. However,
Appellant argues that the Examiner cited two different and distinct medical
lead embodiments described in Boling to meet all the limitations of the
claimed lead. Appeal Br. 7. Specifically, Appellant states that the Examiner
relied upon the "surface cortical lead" of Figures 9-14 of Boling to meet the
claimed proximal end portion with contacts and distal end with electrodes
and generally flat body and the "deep brain" stimulation lead of Figures 1-8,
15, and 16 to meet the claimed limitation of "the body of the distal end
portion is sufficiently stiff to be pushed through subcutaneous tissue without
use of an introducer." Id. Appellant contends that these are separate
embodiments that cannot be combined (id.) and that the Examiner did not
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Application 13/749,489
establish that the surface cortical lead has a distal end portion "sufficiently
stiff to be pushed through subcutaneous tissue without use of an introducer"
(id. at 8-9).
We agree with Appellant that two different embodiments cannot be
combined to show that the claim 1 is anticipated by Boling. The Examiner
cited Boston Scientific Scimed, Inc. v. Cordis Corp., 554 F.3d 982, 991 (Fed.
Cir. 2009) for the holding that it is not inventive to combine two different
embodiments disclosed adjacent to each other in a prior art patent. Ans. 3.
However, the holding from Boston Scientific Scimed relied upon by the
Examiner was in the context of obviousness, not anticipation as is the
rejection here. Boston Scientific Scimed, 554 F.3d at 991.
Nonetheless, the Examiner cited the complete disclosure at column
19, line 49 to column 21, line 49 of Boling in which the surface cortical lead
is described. Final Act. 3. This disclosure describing the surface cortical
lead also has a teaching of a stylet to impart rigidity as does the disclosure
for the deep brain lead 100. Boling discloses for the surface cortical lead
embodiment depicted in Figures 9-14:
The difference between the lead 500 and the lead 100 [ the deep
brain lead] is most notable in the distal portion 510 of the lead
500. The distal portion 510 is configured as an electrode strip
assembly 513. The electrode strip assembly 513 includes a
distal section of the reinforcing sheath 511 having the electrical
conductors 200 wrapped therearound, as well as a core member
540 ( which may be similar to core member 180 or may be any
other type of plug-like member). The core member 540 is
partially disposed within the lumen of the reinforcing sheath
511. A head of the core member 540 extends beyond the distal
reinforcing sheath 511. The core member 540 has a bore
formed therein for receiving the stylet 130 as the stylet 130 is
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Application 13/749,489
fed through the lumen of the reinforcing sheath 511 toward the
distal end of the lead 500.
Boling, col. 20, 1. 56-col. 21, 1. 2.
Thus, Boling discloses a stylet 130 inserted into distal end of the lead
500. The Examiner found that the stylet 130 met the claimed limitation of
"a body of a distal end portion is sufficiently stiff to be pushed through
subcutaneous tissue without use of an introducer," albeit citing the
disclosure of the style for the deep brain lead. Ans. 3. However, the same
disclosure is also found with respect the surface cortical lead.
Appellant contends that a stylet present in the lead does not meet the
limitation that the "body ... is sufficiently stiff to be pushed through
subcutaneous tissue without use of an introducer." Reply Br. 4. Appellant
argues that the Specification discloses embodiments where the body:
is sufficiently stiff to be pushed through subcutaneous tissue on
its own (see Specification at, for example the paragraphs at
page 6, lines 9-21; at page 7, lines 3-9; and at page 10, lines 22-
24; and FIGS. 2-4) and embodiments where one or more sty let
is employed to facilitate pushing of the distal end portion of the
lead through subcutaneous tissue (see Specification at the
paragraph at page 10, lines 10-21.
Appeal Br. 4.
We agree with Appellant that the Specification discloses embodiments
in which the lead is made of a material which imparts the requisite stiffness
(Spec. 7:3-21) and also alternatively of stiffening rods or stylets to confer
the recited stiffness (id. at 10: 10-24). However, while Appellant contends
that the skilled worker would construe the claim to be limited to the
embodiment where the material of the body imparts the stiffness, we have
not been directed to language in the claim that warrants this narrow
construction. The claim requires the body of the medical lead to be stiff
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Application 13/749,489
without use of an introducer. A stylet is not an introducer, and as discussed
by the Examiner, the Specification specifically refers to both introducers and
sty lets as different structural elements (Spec. 1: 17-22) (reproduced above).
The claim, however, only excludes the introducer and the claim does not
recite that the body is formed of a material that makes it stiff, as described in
the Specification for certain embodiments ("Examples of materials that may
he used to form a body 35 having such a stiffness ... " id. at 10:6-7).
Accordingly, Appellant has not provided persuasive arguments that the
claim should be interpreted to exclude a stylet as imparting the claimed
limitation of "sufficiently stiff."
For the foregoing reason, the rejection of claim 1 as anticipated by
Boling is affirmed. Dependent claims 2, 10, and 15 were not separately
argued and therefore fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
REJECTION BASED ON ERICKSON AND DESAI
The Examiner cited Erickson as describing a medical lead having the
claimed proximal end portion with contacts and distal end with electrodes
and generally flat body. Final Act. 4--5. The Examiner found that Erickson
does not disclose the claim limitation where the distal end is "sufficiently
stiff to be pushed through subcutaneous tissue without use of an introducer."
Id. at 5. However, the Examiner fund this limitation is described by Desai.
Id. The Examiner concluded:
It would have been obvious to one having ordinary skill in the
art at the time the invention was made to modify the
implantable medical lead as taught by Erickson to be made
using polyurethane material disclosed in Desai, since both
invention are concerned with the same field of endeavor,
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namely electrical stimulation leads configured to be implanted
within the patient with known biocompatible materials.
Id. at 5---6.
Appellant contends that paddle type electrode of Erickson relied upon
by the Examiner:
... would desirably be soft and flexible to avoid damaging the
dura or spinal cord when implanted. Erickson does suggest that
flexibility of the lead is desired. See Erickson at paragraph
[0058]. In addition, Erickson does suggest that the lead body
does not have a great deal of stiffness, stating that a stylet may
be used as a stiffening member for handling and placing the
lead. See Erickson at paragraph [0065]. Such indications in
Erickson are consistent with what one of skill in the medical
device arts would expect for an epidural spinal cord stimulation
lead; namely, that the lead would be soft and flexible to avoid
damaging the dura or spinal cord during and after implantation.
Appeal Br. 16 (underlining added).
For this reason, Appellant states "there is no good reason why one of
skill in the medical device arts or medicine would make a lead of Erickson
stiffer. Certainly, there is no good reason why one would stiffen a lead of
Erickson to have a stiffness of a lead as disclosed in Desai." Id.
We agree with Appellant that the disclosure at paragraphs 58 2 and 65
of Erickson support the contention that Erickson's lead should be flexible,
and therefore would militate against the Examiner's conclusion that
Erickson would benefit from the stiff material disclosed in Desai. However,
2 For example, in paragraph 58, Erickson teaches: "Depending upon the
form/construction of the electrodes 30a-30d, the segmented nature of the
illustrated first electrode array of this embodiment would improve
longitudinal flexibility of the paddle structure 16. As additional
segmentation of electrodes 30b and 30d would likewise improve transverse
flexibility of the paddle structure 16, such modification is within the scope
of this embodiment of the present invention."
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Appellant expressly points to the disclosure in Erickson at paragraph 65 of a
stylet for stiffening the lead for handling and placing the lead. Appeal Br.
16. As discussed above, Appellant has not distinguished a lead with a stylus
from the claimed "body of the distal end portion is sufficiently stiff to be
pushed through subcutaneous tissue without use of an introducer." The
claim language does not require the body to be formed of the stiff material
nor exclude a stylus. Consequently, a stylet present in the distal end portion
of the lead would make the body "sufficiently stiff to be pushed through
subcutaneous tissue without use of an introducer" as recited in the claims.
For the foregoing reason, the obviousness rejection of claim 1 as
obvious in view of Erickson and Desai is affirmed. Dependent claims 2, 6,
9-1 7, and 21 fall with claim 1 because separate arguments for their
patentability were not provided for them. 37 C.F.R. § 4I.37(c)(l)(iv).
Claims 3-5, 7, and 8, were further rejected based on Colvin.
Appellant does not provide separate arguments for these claim other than
stating that its "teaching fails to cure the deficiencies in the teachings of
Erickson and Desai discussed above." Appeal Br. 18.
TIME PERIOD FOR RESPONSE
This Decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b). Section 4I.50(b) provides "[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review." Section 4I.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
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Application 13/749,489
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the MPEP § 1214.01.
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). See 37 C.F.R.
§§ 41.50(±), 4I.52(b).
AFFIRMED
37 C.F.R. § 4I.50(b)
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