Ex Parte Feler et al

Patent Trials and Appeals Board

Jul 8, 2019

14198260 - (D) (P.T.A.B. Jul. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/198,260 03/05/2014 Joshua R. Feler
35320 7590 07/10/2019
PA TENT/ LEGAL DEPARTMENT
ST. JUDE MEDICAL NEUROMODULA TION DIVISION
6901 PRESTON ROAD
PLANO, TX 75024
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.
14-00SUSO 2011
EXAMINER
JAMIALAHMADI, MAJID
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
07/10/2019 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):
Patent.CRMDSylmar@sjm.com
asjm_Patents@abbott.com
estella.pineiro@abbott.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSHUA R. FELER and
CLAUDIO A. FELER1
Appeal2018-008863
Application 14/198,260
Technology Center 3700
Before MICHAEL L. HOELTER, BRETT C. MARTIN, and
LEE L. STEPINA, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is an Appeal, under 35 U.S.C. § 134(a), from the Examiner's
final rejection of claims 1--4, 6, 7, 12-18, 20, and 22-24. Br. 5. Claims 5,
8-11, 19, and 21 have been canceled. Br. 5. We have jurisdiction under 3 5
U.S.C. § 6(b ). For the reasons explained below, we do not find error in the
Examiner's rejections of claims 1--4, 6, 7, 12-18, 20, and 22-24.
Accordingly, we AFFIRM the Examiner's rejections.
1 "This invention is assigned to Advanced Neuromodulation Systems, Inc."
Br. 3. We refer to the appealing party as "Appellant."
Appeal2018-008863
Application 14/198,260
CLAIMED SUBJECT MATTER
The disclosed subject matter relates "to systems having paddle leads
for generating electric fields proximate to nerve tissue." Spec. ,r 2. Claims
1, 12, and 16 are independent. Claim 1 is illustrative of the claims on appeal
and is reproduced below.
1. A neurostimulating paddle lead comprising:
a lead body having a distal end, a proximal end, and a
central axis extending therebetween, the lead body including
opposite first and second sides that extend between the distal
and proximal ends;
electrodes disposed along the first side of the lead body
and configured to apply a neurostimulation therapy within an
epidural space of a patient, the electrodes being electrically
coupled to conductive pathways that extend through the
proximal end of the lead body, wherein the first side is
configured to engage a dural membrane and the second side is
configured to be exposed to spinal fluid;
wherein the lead body comprises a flexible material that
is configured to flex when a fluid pressure in the epidural space
is imposed on the second side of the lead body by the spinal
fluid, the lead body configured to form a non-planar contour
that folds or curves about the central axis to maintain the first
side against the dural membrane in response to the fluid
pressure imposed on the second side, wherein the lead body is
to flex and conform to the dural membrane when the second
side of the lead body experiences a designated amount of the
fluid pressure between 5 cmH20 and 20 cmH20.
Olsen et al.
Cross, Jr. et al.
McDonald et al.
Pianca et al.
REFERENCES
US 2006/0122678 Al
US 7,697,995 B2
US 2011/0009932 Al
US 8,224,459 B 1
2
June 8, 2006
Apr. 13, 2010
Jan. 13, 2011
July 17, 2012
Appeal2018-008863
Application 14/198,260
THE REJECTIONS ON APPEAL
Claims 1--4 and 6 are rejected under 35 U.S.C. § 102(b) as anticipated
by Cross.
Claims 7, 12-15, and 22 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as unpatentable over Cross and Pianca.
Claims 16 and 20 are rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Cross and Olsen.
Claims 17 and 18 are rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Cross, Olsen, and McDonald.
Claim 23 is rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Cross and McDonald.
Claim 24 is rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Cross, Pianca, and McDonald.
ANALYSIS
The rejection of claims 1-4 and 6
as anticipated by Cross
Appellant argues claims 1--4 and 6 together. See Br. 10-18. We
select independent claim 1 for review, with the remaining claims (i.e., claims
2--4 and 6) standing or falling with claim 1. See 3 7 C.F .R. § 41.3 7 ( c )( 1 )(iv).
Claim 1 includes a limitation directed to a lead body comprising "a
flexible material that is configured to flex when a fluid pressure in the
epidural space is imposed" thereon. More specifically, claim 1 recites that
the lead body will "flex and conform to the dural membrane" when the lead
body "experiences a designated amount of the fluid pressure between 5
cmH20 and 20 cmH20." The Examiner relies on Cross as disclosing the
above limitations, including the anatomical location recited. Final Act. 4--5.
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Appeal2018-008863
Application 14/198,260
However, Cross is silent as to a numerical range of pressure under which the
corresponding lead body will flex. The Examiner finds that Cross' device
will, nevertheless, flex "since the lead body of Cross is made out of a
flexible polyurethane similar to the applicant's invention ... and is also
thin." Final Act. 4, 5 (both referencing Spec. ,r,r 52, 53; Cross 3:9-11,
Abstract). Appellant does not dispute the similarity in material employed by
both the claimed device and Cross' device (compare Spec. ,r 52 with Cross
4:48-51 and/or 4:66-67 and/or 5: 19-22), or that Cross' device is thin (see,
e.g., Cross Abstract, 3:9-11).2 See also Ans. 4--6. Instead, Appellant
contends that Cross "does not literally describe the claimed fluid pressure
range" and also that "Cross does not inherently teach the claimed fluid
pressure range." Br. 13; see also id. at 10.
There is no doubt that Cross teaches a flexible lead body (i.e., Cross
"paddle 16") since Cross states "[f]urther, the flexibility of polyurethane
allows paddle 16 to easily form around the dura mater of the spinal cord."3
Cross 5:19-20. Cross further elaborates onjust how flexible this device is
by explaining that paddle 16 is configured to "eliminate[] any excess
pressure on the dura mater or the spinal cord"; that it's "thickness allows for
ease of implantation with reduced risk of spinal compression"; and, that the
paddle "eliminates excess spinal compression" as may be incurred by other
2 Cross teaches a material thickness of "up to 0.030 inches." Cross Abstract,
3:19-21, 3:48-50. This is less than other lead thicknesses of0.050 and
0.070 inches discussed in Cross' Background section. See Cross 2:26-29,
2:56-63.
3 The Examiner reasons that since Cross' paddle is already designed to flex
around the dura mater of the spinal cord, "then it would flex further when
the paddle is imposed to a fluid pressure" in the recited range. Ans. 5.
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Appeal2018-008863
Application 14/198,260
devices. Cross 5:22-27. Specifically, Cross's device is directed to "an
improved paddle structure to prevent compression of the dura mater against
the spinal cord." Cross 3:7-9. Regardless, Cross is silent as to any
particular pressure range that will cause Cross' thin material to flex.
Appellant stresses this arguing "Cross' general statement to use
polyurethane to form a paddle with a certain thickness does not teach to
form a paddle with the claimed degree of flexibility." Br. 14. Appellant
concludes that the Examiner's "reliance on a general material (polyurethane)
and a thickness (0.030 inches) falls far short of the necessary teaching to
anticipate the claimed degree of flexibility." Br. 14; see also id. at 15. The
Examiner disagrees stating, "[ s ]ince Cross discloses all of the structural
elements in the same arrangement as claimed, then it is fully configured to
function as claimed." Ans. 6.
We have been instructed that "[c]laims cannot be 'anticipated' by
devices that are not the same." TF3 Limited v. Tre Milano, 894 F.3d 1366,
1374 (Fed. Cir. 2018). However, the reverse is also true, i.e., that claims can
be anticipated by devices that are the same. Further, we have been
instructed that "a reference need not always include an express discussion of
the actual combination to anticipate." Blue Calypso, LLC v. Groupon, Inc.,
815 F.3d 1331, 1344 (Fed. Cir. 2016). In other words, "a reference can
anticipate a claim even if it 'd[ oes] not expressly spell out' all the limitations
arranged or combined as in the claim, if a person of skill in the art, reading
the reference, would 'at once envisage' the claimed arrangement or
combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d
1376, 1381 (Fed. Cir. 2015) (alteration in original). "Rather, anticipation
only requires that those suggestions be enabling to one of skill in the art."
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Appeal2018-008863
Application 14/198,260
Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1379
(Fed. Cir. 2001 ). We are further informed that, in assessing the propriety of
an anticipation rejection, "it is proper to take into account not only specific
teachings of the reference but also the inferences which one skilled in the art
would reasonably be expected to draw therefrom." In re Preda, 401 F.2d
825, 826 (CCPA 1968). In summation, "[a] reference anticipates a claim if
it discloses the claimed invention 'such that a skilled artisan could take its
teachings in combination with his own knowledge of the particular art and
be in possession of the invention."' In re Graves, 69 F.3d 1147, 1152 (Fed.
Cir. 1995) ( citations omitted).
Here, Cross clearly discloses employing the same material as
employed by Appellant, and also that Cross' material thickness is "up to
0.030 inches" (meaning that it can also be less than this amount). See supra.
We are further guided by Cross' explicit discussion of being flexible enough
to reduce/eliminate the application of pressure itself. See supra. Further, the
claimed pressure range of 5 cmH20 to 20 cmH20, when considered from the
perspective of Cross' teachings (which describes a thickness of less than 1
millimeter), is a relatively significant amount of pressure (nearly 2 to 8
inches of water) for such a pliable material to withstand with no flexing.
We understand that the Examiner bears the initial burden "to set forth
the basis for any rejection" and that "[ o ]nee the applicant is so notified, the
burden shifts to the applicant to rebut the prima facie case with evidence
and/or argument." Hyatt v. Dudas, 492 F.3d 1365, 1369-70 (Fed. Cir.
2007). We are further instructed that "[a]n examiner's belief, however, must
be tethered to or grounded in some rationale so as to establish a prima facie
case of anticipation." In re Chudik, 674 Fed. App'x. 1011, 1015 (Fed. Cir.
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Appeal2018-008863
Application 14/198,260
2017). In view of the above, there is ample indication that the Examiner's
anticipation rejection is adequately tethered and/or grounded, thereby
providing Appellant with an opportunity to explain how the Examiner's
prima facie case is in error. Appellant, however, has not provided evidence
or effective technical argument as to why Cross' material would not flex
when subject to the recited pressure, as one would reasonably expect.
Instead, Appellant seems to rely solely on the fact that Cross is silent
regarding the disclosure of actual pressure values. See Br. 13-15.
We do not find Cross' silence in the matter to be fatal in view of the
guidance provided by our reviewing court above. Additionally, we have
been instructed that it is well settled that where "the claimed and prior art
products are identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product." In re Best, 562 F.2d 1252, 1255
(CCP A 1977). This is applicable "[ w ]hether the rejection is based on
'inherency' under 35 U.S.C. § 102, on 'prima facie obviousness' under 35
U.S.C. § 103,jointly or alternatively, the burden of proof is the same, and its
fairness is evidenced by the PTO' s inability to manufacture products or to
obtain and compare prior art products." Best, 562 F.2d at 1255.
In view of the above, we are not persuaded by Appellant's contention
that "Cross does not describe or suggest providing a lead body with any
particular degree of flexibility." Br. 15. We instead are persuaded that the
Examiner has provided a prima facie case of anticipation, and Appellant has
not identified reversible error.
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Appeal2018-008863
Application 14/198,260
Appellant's further reliance on advantages provided by the claimed
device, with such advantages being described in Appellant's Specification
(see Br. 16-17), is also not persuasive of Examiner error. This is because
we cannot read unclaimed features from the Specification into the claims.
See In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). More
succinctly, unclaimed features cannot impart patentability. See In re Hiniker
Co., 150 F.3d 1362, 1368 (Fed. Cir. 1998).
Thus, in summation, we sustain the Examiner's rejection of claim 1--4
and 6 as being anticipated by Cross. 4
The remaining rejections of obviousness
involving the combination of Cross with additional references
Appellant's arguments presented with respect to independent claims
12 and 16 rely on the same arguments presented above. See Br. 18, 19
(arguing that Pianca and Olsen do "not make up for the foregoing deficiency
of Cross"). Regarding statements presented by Appellant with respect to
dependent claims 20 and 22, Appellant re-addresses Cross' asserted failure
to teach a paddle having the requisite degree of flexibility. See Br. 21.
Regarding the remaining dependent claims (i.e., claims 7, 13-15, 17, 18, 23,
and 24 ), Appellant simply asserts that these claims are allowable because
their respective parent claim is allowable. See Br. 22.
4 Regarding dependent claim 6, Appellant contends that "Cross does not
suggest any reason for the lead body to be more flexible than a convention
paddle." Br. 20. However, Appellant is disregarding Cross' discussion of
prior solutions in Cross' Background section, where Cross identified
problems associated with the greater thicknesses of these earlier solutions.
See supra. Regarding dependent claims 2--4, Appellant simply relies on
their dependency from claim 1. See Br. 21-22.
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Appeal2018-008863
Application 14/198,260
Such arguments/assertions/statements are not persuasive of Examiner
error. We sustain the Examiner's rejections of claims 7, 12-18, 20, and 22-
24.
DECISION
The Examiner's rejections of claims 1--4, 6, 7, 12-18, 20, and 22-24
are 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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