Ex Parte Gerber

Patent Trials and Appeals Board

Jun 20, 2019

11591171 - (D) (P.T.A.B. Jun. 20, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/591,171 10/31/2006
71996 7590 06/24/2019
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
Martin T. Gerber
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.
1023-586US01/P0027167.00 7189
EXAMINER
LEVICKY, WILLIAM J
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
06/24/2019 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
Exparte MARTIN T. GERBER
Appeal2017-007836
Application 11/591, 171
Technology Center 3700
Before, LISA M. GUIJT, JAMES J. MAYBERRY, and ERIC C. JESCHKE,
Administrative Patent Judges.
GUIJT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner's
rejection of claims 1, 4--33, and 35--40.2 We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART and enter NEW GROUNDS OF
REJECTION of (i) claims 1, 13, 16, 17, 23, 35, 37, and 39 under 35 U.S.C.
1 Medtronic, Inc. and Medtronic plc are identified as the real parties in
interest Appeal Br. 3.
2 Appeal is taken from the Final Office Action dated July 25, 2016.
Appeal2017-007836
Application 11/ 591, 171
§ 102(b) as anticipated by Osypka; (ii) claims 10 and 11 under 35 U.S.C.
§103(a) as unpatentable over Osypka; (iii) claims 7, 14, 15, and 18-20 under
35 U.S.C. § 103(a) as unpatentable over Osypka and Cates; (iv) claims 8 and
9 under 35 U.S.C. §103(a) as unpatentable over Osypka and Okajima; (v)
claim 12 under 35 U.S.C. §103(a) as unpatentable over Osypka and Doan;
( vi) claim 21 as unpatentable over Osypka, Cates, and Wittkampf; ( vii)
claim 22 as unpatentable over Osypka and Whitehurst; and (viii) claims 36,
38, and 40 as unpatentable over Osypka and Mamo; all pursuant to our
authority under 37 C.F.R. § 41.50(b).
CLAIMED SUBJECT MATTER
Claims 1, 13, 23, and 24 are the independent claims on appeal. Claim
1, reproduced below, is exemplary of the subject matter on appeal.
1. A medical lead comprising:
an elongated member having a proximal end and a distal
end, the proximal end being configured to electrically and
mechanically couple to a medical device comprising an electrical
stimulation generator;
at least one stimulation electrode disposed closer to the
distal end of the elongated member than the proximal end of the
elongated member, the at least one stimulation electrode being
configured to deliver electrical stimulation generated by the
medical device to a patent when the elongated member is
electrically and mechanically coupled to the medical device; and
at least one threaded fixation structure extending around a
portion of an outer surface of the elongated member and
configured to engage tissue within the patient to resist migration
of the medical lead, wherein the at least one fixation threaded
structure is at least one of distal to all stimulation electrodes
disposed along the elongate member or disposed at least partially
over the at least one stimulation electrode.
2
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Application 11/ 591, 171
THE REJECTIONS
I. Claims 10, 11, 31, and 32 stand rejected under 35 U.S.C. § 112,
second paragraph. 3
II. Claims 1, 4--6, 10, 11, 13, 16, 17, 23, 35, 37, and 39 stand
rejected under 35 U.S.C. § I03(a) as unpatentable over Osypka (US
4,550,737; issued Nov. 5, 1985) and Hastings (US 2006/0085042 Al;
published Apr. 20, 2006).
III. Claims 24, 26, 27, 31, and 32 stand rejected under 35 U.S.C.
§ I03(a) as unpatentable over Gerber (US 2005/0010260 Al; published Jan.
13, 2005) and Hastings.
IV. Claims 7, 14, 15, and 18-20 stand rejected under 35 U.S.C.
§ I03(a) as unpatentable over Osypka, Hastings, and Cates (US
2004/0230282 Al; published Nov. 18, 2004).
V. Claims 8 and 9 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Osypka, Hastings, and Okajima (US 5,554,139; issued
Sept. 10, 1996).
VI. Claim 12 stands rejected under 35 U.S.C. § I03(a) as
unpatentable over Osypka, Hastings, and Doan (US 5,456,708; issued Oct.
10, 1995).
VII. Claim 21 stands rejected under 35 U.S.C. § I03(a) as
unpatentable over Osypka, Hastings, Cates, and Wittkampf (US 4,142,530;
issued Mar. 6, 1979).
3 The Examiner's rejection of claims 1, 4--12, 25-33, 35, and 36 under
35 U.S.C. § 112, second paragraph, has been withdrawn. Ans. 2.
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VIII. Claim 22 stands rejected under 35 U.S.C. § I03(a) as
unpatentable over Osypka, Hastings, and Whitehurst (US 2005/0102006 Al;
published May 12, 2005).
IX. Claim 25 stands rejected under 35 U.S.C. § I03(a) as
unpatentable over Gerber, Hastings, and Hansmann (US 2005/0215946 Al;
published Sept. 29, 2005).
X. Claim 28 stands rejected under 35 U.S.C. § I03(a) as
unpatentable over Gerber, Hastings, and Cates.
XI. Claim 29 and 30 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Gerber, Hastings, and Okajima.
XII. Claim 33 stands rejected under 35 U.S.C. § I03(a) as
unpatentable over Gerber, Hastings, and Doan.
XIII. Claims 36, 38, and 40 stand rejected under 35 U.S.C. § I03(a)
as unpatentable over Osypka, Hastings, and Mamo (US 2002/0147485 Al;
published Oct. 10, 2002).
ANALYSIS
Rejection I
With respect to the threaded fixation structure, claims 10 and 31
require, in relevant part, "a pitch between adjacent threads of approximately
0.5 millimeters (mm) to approximately 3 mm" (Appeal Br. 42, 47 (Claims
App.) (emphasis added)), and claims 11 and 32 require, in relevant part, "a
thread height between approximately O. I millimeters (mm) and
approximately 3 mm" (id. at 43, 47 (Claims App.) (emphasis added)). The
Examiner finds that claims 10, 11, 31, and 32 are indefinite because the
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Specification "fails to define the metes and bounds" of the claim term
"approximately." Final Act. 4; see also Ans. 2-3.
Appellant argues that "it is well established that claim terms such as
'substantially' and 'approximately' do not necessarily render the claims
indefinite," and that, as claimed, the "scope [ of the claim term
'approximately'] would be understood by persons in the field of the
invention." Appeal Br. 11-12 (citations omitted); see also id. at 12 (arguing
that "the Examiner has failed to establish that a person having ordinary skill
in the art would not have been able to ascertain the scope of the terms of
claims 10, 11, 31, and 32"). Appellant further submits that, for example,
with respect to claim 10,
the recitation of 'the at least one threaded fixation structure
comprises a pitch between adjacent threads of approximately 0.5
millimeters (mm) to approximately 3 mm" ... is objectively
contextualized by the claim from which it depends. A person of
ordinary skill in the art would have understood the approximate
values recited in claim 10 are to be read in view of the 'at least
one threaded fixation structure [being] configured to engage
tissue within the patient to resist migration of the medical lead,'
recited in claim 1, and that at least this language of claim 1
provides a meaningful definition to the values in claim 10. Thus,
claim 10 is amendable to construction at least in light of claim 1,
which, in addition to the rest of Appellant's [S]pecification,
provides context for the values of the pitch recited in claim 10.
For at least similar reasons, claims 11, 31, and 3 2 likewise are
amenable to construction.
Reply Br. 4.
Our reviewing court has stated that terms of degree are not "inherently
indefinite" and that "[ c ]laim language employing terms of degree has long
been found definite where it provided enough certainty to one of skill in the
art when read in the context of the invention." Interval Licensing, 766 F.3d
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at 1370 ( citations omitted). To satisfy the statute, however, "[t ]he claims,
when read in light of the specification and the prosecution history, must
provide objective boundaries for those of skill in the art." Id. at 1371
( citations omitted). The scope of claim language cannot depend solely on
the unrestrained, subjective opinion of a particular individual purpmiedly
practicing the invention. See In re Musgrave, 431 F.2d 882, 893 (CCPA
1970) (noting that "[a] step requiring the exercise of subjective judgment
without restriction might be objectionable as rendering a claim indefinite").
The Specification discloses that
[t]hreaded fixation structure 70 may have a pitch between
approximately 0.5 millimeters (mm) and 3 mm. The pitch may
be less than approximately 0.5 mm or greater than 3 mm ....
Generally the height is between approximately 0.1 mm and 3
1nm. However, other ernbodiments of threaded fixation structure
70 may include heights smaller than approximately 0.1 mm or
greater than 3 mm.
'-'
Spec.~ 64.
\Ve determine that the Examiner has provided a satisfactory showing
that the claim tenn "approxhnate1y" is indefinite as a tenn of degree,
because the Specification fails to provide an objective standard for
determining the meaning of approximately 0.5 to 3 mm, and approximately
0.1 and 3 mm; rather, the Specification discloses that such pitch and height
rnay have any value. Therefore, Appellant has the burden to provide support
as to the clear meaning of the claim term "approximately." See In re
Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014).
Appellant's argument that the claim term ''approximately" means any
pitch or height that meets the function of the threads as specified in claim I
(i.e., to engage tissue within the patient to resist migration of the medical
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lead) is insufficient, because Appellant has not provided any evidence that
one skilled in the art would clearlv have understood the degree to which the
~ ~
pitch and height may vary and still be encompassed by the claim term
"approximately" based on such use.
Accordingly, we sustain the Examiner's rejection of claims 10, 11, 31,
and 32 under 35 U.S.C. § 112, second paragraph, as indefinite.
Rejection fl
Independent claims land 23, and dep_endent claims 4 6, 10, 11, 35, and 39
Regarding independent claims l and 23, the Examiner finds that
Osypka teaches the medical 1ead, as claimed, including a threaded fixation
structure (i.e., thread 6), except that Osypka fails to disclose that the
threaded fixation structure is at least distal to all of the stimulation electrodes
or disposed at least partially over at least one stimulation electrode, as
claimed. Final Act. 5----6 ( citing Osypka, Fig. 1 ). The Examiner relies on
Hastings for disclosing that "it is known" to dispose a fixation threaded
structure (i.e., helical tine l 105E) distal to all stimulation electrodes (i.e.,
electrode 1135E) or at least partially over a simulation electrode (i.e., tip
portion 1123E, wherein the surface of tip portion 1123E may function as the
distal electrode l 135E), as claimed, "to provide improved placement by
having the fixation element guide the electrodes into place." Id. at 6 (citing
Hastings ,-r O l O 1, Fig. l lE).
The Examiner proposes rnodifying Osypka's electrode lead "by
having the fixation mechanism extended over the stimulation electrode as
shown by Hastings to assist in placing the electrode in position." Ans. 4.
The Examiner specifically explains that
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[t]he modification does not remove the screw thread 6 of Osypka
and replace it with the screw thread of Hastings, but teaches that
the screw thread of Osypka can be modified to extend over the
stimulation electrode which provides the fixation element the
ability to penetrate the opening of the trabecular network more
easily ( without overcoming the distance of the distal electrode
without a fixation mechanism) and guide the electrode(s) into
place.
id. at 4----5.
Appellant argues that the Examiner's modification (i.e., extending
Osypka's thread 6 over the stimulation electrode) results in Osypka's
exposed stimulation surface 5a being covered by the electrically insulating
tabular sleeve 4a, which would prevent the stimulation surface 5 from both
contacting and delivering electrical stimulation to the heart walL Reply Br.
7-8.
Osypka discloses that
electrode lead 1 indud[es] a flexible conductor lA having a first
end portion 1 a coupled to the casing 2 and a second end portion
3 distal from the casing 2 and having a substantially
hemispherical head 5 provided with an exposed stimulation
surface Sa .. ...
[T]he electrode lead 1 further comprises ... anchoring
means 4 which can be embedded in the trabecular network of the
heart and is disposed immediately or shortly behind the
stimulation surface Sa, as considered in the direction of
propagation of stimulating pulses from the interior of the casing
2 toward the surface Sa. The anchoring means 4 comprises ...
a hollow screw ... made of a yieldable (preferably soft) material
and includes a tabular sleeve or shell 4a .... The sleeve 4a
constitutes an insulating means for the distal end portion 3 of the
conductor 1 A. The illustrated screw 4 has a single thread 6.
Osypka 4:10-----33.
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Figure 2 of Osypka is reproduced below.
Figure 2 depicts "the distal end portion of the electrode lead and ... one
form of anchoring means," wherein screw thread 6 is fonned on skeve 4a.
Osypka 3:61-65.
\Ve are persuaded by Appellant's argument that Osypka's threaded
fixation structure is anchoring means 4, which is comprised of a hollow
screw that includes both sleeve 4 and thread 6, and that modifying Osypka
according to the Examiner's explicit directions supra (i.e., so that the screw
thread extends over the stimulation electrode) means moving insulating
sleeve 4a distaHy over stimulation head 5a, such that stimulation head 5a is
no longer suitabk for the purpose of contacting and delivering ekctrical
stimulation to the heart wall. The Examiner's reliance on Hastings for
positioning a threaded fixation structure either distal to all electrodes or
paiiially over an electrode does not cure this deficiency in the Examiner's
proposed modification.
Accordingly, we do not sustain the Examiner's rejection of
independent claims l and 23, and claims 4-6, 10, 11, 35, and 39 depending
therefrom.
Independent claim 13 and dependent claims 16, 17, and 3 7
The Examiner relies on the same modification of Osypka' s medical
lead, in view of Hastings, in the rejection of independent claim 13, as relied
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on in the rejection of claim 1 supra. Final Act. 8----9; Ans. 9 (relying on the
modification set forth for claim 1 ). Thus, for essentially the same reasons as
set forth supra, we also do not sustain the Exarniner's rejection of
independent claim 13 and claims 16, 17, and 37 depending therefrom.
Rejection Ill
Independent cl aim 2 4
Regarding independent claim 24, the Examiner finds that Gerber
teaches an elongated member configured as claimed, including a conduit
disposed within the elongated member and an exit pmi configured as
claimed for the delivery of drugs, and also a fixation structure extending
around a pmiion of an outer surface of the elongated member to engage
tissue, as claimed. Final Act 11 (citing, e.g., Gerber ,-r 121 C'[d]rug delivery
catheter 300 may also be incorporated into lead 16 or 18")). The Examiner
determines that Gerber fails to disclose a threaded fixation structure, as
claimed, and relies on Hastings for disclosing that "it is known" to use
threaded fixation structures for engaging tissue to resist migration of the
elongated member, as claimed (i.e., helical tine l 105E). Id. at 11----12 (citing
Hastings, Fig. l lE). The Examiner reasons, inter alia, that it would have
been obvious to modify Gerber's implantable neurological stimulator with at
least one threaded fixation stnicture, as taught by Hastings, because "it is
well known in the art that adding a tine or fixation mechanism to a structure
assists in keeping the structure ( e.g., catheter) in place and resisting
migration." Ans. 10.
Appellant argues that
the Examiner has not shown that modifying the system described
by Gerber to include the "helical tine 1105E" described by
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Hastings would have provided "the predictable results of
maximizing therapeutic effect by reducing migration from the
desired location." For example, the Examiner has not shown that
a person of ordinary skill in the art would have understood the
"helical tine 1105E" described by Hastings, which is described
as being used to secure a leadless device to the myocardium, to
have been suitable for resisting migration of Gerber's dn1g
catheter from a location adjacent to a sacral nerve.
Appeal Br. 27 (footnotes omitted) ( citing, e.g., Gerber ~f 70; Hastings i1100);
see also Reply Br. 14----15.
\Ve are not persuaded by Appellant's argument. Gerber discloses,
with reference to Figure 8C, a "quadrapolar lead having tined lead anchors
19," and provides representative examples of "tined and other types of leads
suitable, adaptable or modifiable for use in conjunctions with [implantable
medica1 devices]." Gerber i198. Hastings discloses that "the electrode
assembly may include an attachment mechanism that has at least one
fastener," wherein "the attachment mechanism may include a tine, screw,
barb, or hook" Hastings ir 11 (emphasis added). Where "a patent claims a
structure already known in the prior art that is altered by the mere
substitution of one element for another known in the field, the combination
must do more than yield a predictable result." See KSR Int 'l Co. v. Teleflex,
Inc., 550 U.S. 398,416 (2007). Here, Hastings discloses that tines and
screw threads are known substitutes for attachment mechanisms (or fixation
structures) used by electrode assemblies, and Gerber discloses that the lead
rnay be modified as known in the art. Thus, the Examiner has provided
reasoning with rational underpinning.
Accordingly, we sustain the Examiner's rejection of independent
claim 24 under 35 U.S.C. §103(a) as unpatentable over Gerber and Hastings.
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Appellant chose not to present arguments for the patentability of claims 26
and 27, which depend from claim 24, apart from the arguments presented for
claim 24. Appeal Br. 27. Thus, for essentially the same reasons set forth
supra, we also affirm the Examiner's rejection of claims 26 and 27 under 35
U.S.C. § 103(a) as unpatentable over Gerber and Hastings.
Dependent claims 31 and 32
Claims 31 and 32, which depend from independent claim 24, recite, in
relevant part, "wherein the at least one threaded fixation structure comprises
a pitch between approximately 0.5 millimeters (mm) and 3 mm" and "a
thread height between approximately 0.1 millimeters (mm) and 3 mm."
Appeal Br. 47 (Claims App.). The Examiner determines that it would have
been obvious to have modified Gerber's fixation structure, as modified to
include threads as taught by Hastings, to have the claimed ranges of pitch
and height, because the general conditions of the claim are disclosed in the
prior art, and therefore, discovering the optimum or workable ranges
involves only routine skill in the art. Final Act 13 (citing In re Aller, 220
F.2d 454, 456 (CCPA 1955)). The Examiner determines that "changing
pitch or thread height of a threaded structure involves only routine skill in
the art which adjusts the surface area of the thread []to hold the lead in
place" and in that "[t]he smaller the pitch and the greater the thread height,
the greater amount of the surface area of the fixation structure." Ans. 8; id.
at 8-9, 10-11.
Appellant argues that In re Aller requires "the Exarniner must show
that only routine experirnentation would be involved in the optimization of
an applied art reference to an-ive at the claimed subject matter," and that
here, "the Examiner failed to establish that a person having ordinary skill in
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the art ... would have an-ived at the claimed subject matter ... by only
routine experimentation." Appeal Br. 23; id. at 27----28 (relying on the
arguments presented for claims l O and 11 ); Reply Br. 12-13.
"Where the general conditions of a claim are disclosed in the prior art,
it is not inventive to discover the optimum or workable ranges by routine
experimentation." Aller, 220 F.2d at 456. This rule is limited to cases in
which the optimized variable is a "result-effective variable." In re Antonie,
559 F .2d 618, 620 (CCP A 1977). Here, Appellant does not dispute that the
height and pitch of a threaded fixation device for an implantable medical
device are recognized in the prior art as result-effective variables, nor does
Appellant dispute the Examiner's determination that such variabfos are
known to effect the surface area of a fixation structure for holding an
implantable medical device in place.
Thus, the Examiner has stated a prima facie case that the ranges
recited in claims 31 and 32 are unpatentable, shifting the burden to
Appellant to dernonstrate that the claimed ranges are critical or produce a
new and unexpected result different in kind (i.e., not merely in degree) from
the results of the prior art. See, e.g., In re Applied Materials, Inc., 692 F.3d
1289, 1297 (Fed. Cir. 2012) ("The outcome of optimizing a result-effective
variable may still be patentable if the claimed ranges are critical and produce
a new and unexpected result which is different in kind and not merely in
degree from the results of the prior art.") ( quotations omitted). Appellant
has mistakenly assigned this burden to the Examiner by requiring the
Examiner to prove that the results are other than critical or unexpected, or as
stated by Appellant, due to routine experimentation.
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Accordingly, we sustain the Examiner's rejection of claims 31 and 32
under 35 U.S.C. § 103(a) as unpatentable over Gerber and Hastings.
Rejections IV-VIII and XIII
Regarding claims 7-9, 12, 14, 15, 18-22, 36, 38, and 40, which
depend from one of independent claims 1, 13, and 23, the Examiner's
reliance on the following prior art references does not cure the deficiencies
in the Examiner's reliance on Osypka discussed supra with respect to
independent claims 1 and 13: (i) Cates for teaching the use of a sheath or
folding down the threaded fixation structure (Rejection IV (claims 7, 14, 15,
and 18-20)); (ii) Okajima for teaching helicoil reinforcement members
(Rejection V (claims 8 and 9)); (iii) Doan for teaching threaded fixation
structures made of biocompatible metallic alloy (Rejection VI ( claim 12));
(iv) Wittkampf for teaching that it is known to pull a lead in a backward
direction (Rejection VII (claim 21)); (v) Whitehurst for teaching that it is
known to use an electrode placed adjacent to the occipital nerve (Rejection
VIII (claim 22)); and (vi) Mamo for teaching that it is known to use a lead
extension (Rejection XIII (claims 36, 38, and 40)). 4
Accordingly, for essentially the same reasons stated supra in
connection with our analysis of Rejection II, we do not sustain the
Examiner's rejection of claims 7-9, 12, 14, 15, 18-22, 36, 38, and 40.
4 Recitation of "the lead extension" in claim 40 lacks antecedent basis.
Appeal Br. 48 (Claims App.).
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Rejections IX-XII
Regarding claims 25, 28-30, and 33, which depend from independent
claim 24, Appellant argues that the Examiner's reliance on Hansmann,
Cates, Okajima, and/or Doan, fails to overcome the deficiencies in the
Examiner's rejection of claim 24. Appeal Br. 35-37. Because we are not
persuaded that the Examiner's rejection of claim 24 is erroneous, for
essentially the same reasons as stated supra with respect to Rejection III, we
also sustain the Examiner's rejection of claims 25, 28-30, and 33 as
unpatentable over Gerber and Hastings, and in further view of Hansmann,
Cates, Okajima, and/or Doan.
NE\V GROUNDS OF REJECTION
(i) Anticipation by 05Jpka: Claims 1, 13, 16, 17, 23, 35, 3 7, and 39
(Relating to Original Rejection fl)
Independent claim 1
Figure 3 of Osypka is reproduced below.
FlG, 3
Figure 3 depicts "the structure of FIG. 2 with a portion of the anchoring
means and of the head which defines the stimulation surface broken away."
Osypka 3:66----68. Osypka discloses that
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FIG. 3 shows that the electrode lead 1 has an axial passage 9
which receives a so-called guide wire 109, and that the shank Sb
of the head 5 has a rear end face provided with a socket 10
reception of a complementary end portion 110 of the guide wire
109 .. .. The guide wire 109 is rotated in a clockwise direction in ._,
order to drive the anchoring screw 4 home, i.e., to advance its
thread 6 into the trabecular network in the selected portion of the
heart so that the stimulation surface Sa is in an optimum position
for transmission of pulses to the adjacent portion of the heart.
Actually, the screw thread 6 penetrates into and is held in the
opening of the trabecular network .... The guide wire 109 is
caused to rotate in the passage 9 and to thereby rotate the screw
4 as well as the head 5. However, it is equally within the purview
of the invention to omit the guide wire 109 and to drive the screw
'-'
4 home by rotating the entire electrode lead 1; in such pacemaker
systems, the screw 4, the head 5 and the insulating sheath lb of
the lead 1 can rotate as a unit
Osypka 3:37-54.
\Ve find that Osypka alone discloses the limitations of claim 1. In
particular, we find that Osypka discloses a medical lead (i.e., electrode lead
1) comprising an elongated member having a proximal end configured as
claimed (i.e., flexible conductor IA having a first end portion Ia coupled to
the casing 2). We also find that Osypka discloses a stimulation electrode
configured to deliver electrical stimulation and comprised of head 5,
stimulation surface 5a, and shank 5b. In particular, Figure 3 depicts, by
hatching, that head 5 is a single piece including surface 5a and shank 5b.
Moreover, claim 1 does not require the stimulation electrode to be limited to
only that structure of an electrode having an exposed surface for providing
stimulation (i.e., Osypka's surface 5a). See, e.g., 37 C.F.R. § 1.84(h)(3)
("Hatching must be used to indicate section portions of an object . ... The
various parts of a cross section of the same item should be hatched in the
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same manner .... The hatching of juxtaposed different elements must be
angled in a different way.").
Notably, Osypka's stimulation electrode (i.e., head 5 including surface
5a and shank 5b) is depicted as a separate structure from electrode lead 1
( or insulation sleeve 1 b) because the hatching identifying Osypka' s
stimulation electrode is distinct from hatching used to identify Osypka' s lead
1, as evidenced by Figure 3. Osypka's stimulation electrode (i.e., head 5
including surface 5a and shank 5b) is also disposed closer to the distal end
than the proximal end of the elongated member (i.e., flexible conductor IA),
as claimed.
We further find that Osypka discloses a threaded fixation structure
comprised of a hollow screw, which includes both sleeve 4 and thread 6,
such that, as depicted by Osypka' s Figure 3, the threaded fixation structure
extends around a portion of an outer surface of the elongated member (i.e.,
sleeve 4a is depicted as extending around and over insulated sheath lb of
flexible conductor 1A)5 and is configured to engage tissue within the patient
to resist migration of the medical lead. See Osypka, 3:37-54, Fig. 3. We
also find that Osypka's Figure 3 depicts a fixation threaded structure (i.e.,
sleeve 4a) disposed at least partially over a stimulation electrode (i.e., head
5) because sleeve 4a is depicted as being disposed over the shank 5b of head
5.
5 It is unclear whether thread 6 alone as a threaded fixation structure
extends around a portion of the structure 1 b of the elongated member or
electrode lead 1; thus, we interpret sleeve 4a including thread 6 as
corresponding to the claimed threaded fixation structure. See, e.g., Osypka,
Fig. 3.
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Accordingly, we enter a NEW GROUND OF REJECTION of claim 1
under 35 U.S.C. §102(b) as anticipated by Osypka.
Dependent claim 4
Regarding claim 4, which depends from independent claim 1 and
further requires "a tapered tip at the distal end of the elongated member,
wherein the tapered tip includes the portion of the outer surface of the
elongated member [ around which at least one threaded fixation structure
extends]," we determine that although Osypka discloses a tapered tip at the
distal end of the elongated member (i.e., head 5), as defined in the
Specification, Osypka does not disclose that the tapered tip (i.e., head 5)
includes the portion of the outer surface of the elongated member around
which the threaded fixation structure extends, as claimed. See Appeal Br.
21, 41 (Claims App.); see also Spec. ,r 65 ("tapered tip 80 may be curved in
any parabolic shape"); Osypka, Fig. 3 ( showing the tip and thread structure
of Osypka's lead 1); Final Act. 6 (apparently relying on a combination of
Osypka and Hastings); Appeal Br. 21 ("Osypka fails to describe a tapered tip
including a portion of an outer surface of the elongated member, around
which portion at least one threaded fixation structure extends"). Rather,
Osypka's Figure 3, for example, shows that the threaded fixation (i.e., sleeve
4a) structure does not extend around tapered head 5. Thus, Osypka alone
does not anticipate claim 4.
Dependent claim 5
Regarding claim 5, which depends from independent claim 1 and
recites, in relevant part, "wherein the portion of the outer surface member
[ around which at least one threaded fixation structure extends] includes the
at least one stimulation electrode," we determine that Figure 3 of Osypka
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shows that such portion, identified supra with respect to claim 1, does not
include the stimulation electrode (i.e., head 5, shank 5b ). See Appeal Br. 42
(Claims App.); Final Act. 7 (apparently relying on a combination of Osypka
and Hastings). Thus, Osypka alone does not anticipate claim 5.
Dependent claim 6
Regarding claim 6, which depends from independent claim 1 and
recites, in relevant part, "wherein a plurality of threaded fixation structures
are formed around the portion of the outer surface of the elongated member
to simulate a continuous threaded fixation structure," we determine that
Osypka fails to disclose that more than one (or a plurality) of Osypka's
threaded fixation structure (i.e., the hoHow screw including both sleeve 4
and thread 6 as determined with respect to the new grounds of rejection of
claim 1 supra) may be assembled onto electrode lead Las required by claim
6. See, e.g., Osypka Figs. 1----4 (depicting a single hollow screw assembled
onto electrode lead I). Therefore, Osypka alone does not anticipate claim 6.
See Appeal Br. 42 (Claims App.); see also Final Act. 7 (apparently relying
on a combination of Osypka and Hastings).
Independent claim 13
We determine that Osypka anticipates the method recited in
independent claim 13, which includes the steps of inserting a medical lead
into a patient and rotating the lead to engage the threaded fixation structure
with tissue of the patient to resist migration of the lead, wherein the lead is
configured to couple to a medical device, as in claim 1, and also comprises
the structure recited in claim 1. See Appeal Br. 43 (Claims App.). In other
words, we agree with the Examiner's findings that Osypka discloses such
method steps. See, e.g., Final Act. 8-9. For example, Osypka discloses that
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"it is equally within the purview of the invention to omit the guide wire 109
and to drive the screw 4 home by rotating the entire electrode lead." Osypka
4:65---68. Further, we apply our findings to the limitations of claim 13 to the
extent the limitations are similar to claim 1 supra. (Notably, Appellant's
arguments presented with respect to claim 13 are the same as Appellant's
arguments presented for claim 1 supra.) See Appeal Br. 24.
Accordingly, we enter a NEW GROUND OF REJECTION of claim
13 under 35 U.S.C. §102(b) as anticipated by Osypka.
Dependent claim 17
Claim 1 7, which depends from independent claim 13, further requires,
in relevant part, "rotating the lead to disengage the at least one threaded
fixation structure from the tissue in the patient." Appeal Br. 44 (Claims
App.).
We rely on the Examiner's findings, which are undisputed by
Appellant, with respect to Osypka, in that the Examiner finds Osypka
discloses the limitation of claim 17. Final Act. 9 ( citing Osypka 7 :23-31 );
see Appeal Br. 25 ( arguing that claim 1 7 is patentable based on its
dependence on claim 1 and the arguments presented by Appellant for the
patentability of claim 1 ). Indeed, Osypka discloses that "the improved
electrode lead can be readily removed from a vein by the simple expedient
of rotating the screw 4 ... in a direction to move the stimulation surface Sa
... away from the selected portion of the heart." Osypka 7:28-32.
Accordingly, we enter a NEW GROUND OF REJECTION of claim
16 under 35 U.S.C. §102(b) as anticipated by Osypka.
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Independent claim 23
Independent claim 23, requires, in addition to the limitations recited in
claim 1, "a stimulator configured to deliver electrical stimulation therapy to
a patient via the at least one stimulation electrode of the medical lead within
the patient, the proximal end of the elongated member being configured to
electrically and mechanically couple to the simulator." Appeal Br. 45
( Claims App.).
As discussed supra with respect to claim 16, we agree with the
Examiner's findings, which are undisputed by Appellant, that Osypka
discloses a stimulator, as claimed. See Final Act. 5; see also Appeal Br. 25
( arguing that claim 23 is patentable based on the arguments presented by
Appellant for the patentability of claim 1 ). In other words, although Osypka
acknowledges that "[t]he construction of the parts in the interior of the
casing 2 form not part of the invention" (Osypka 4: 14--17), and therefore,
Osypka lacks a detailed description of such stimulator, Osypka inherently
discloses a stimulator within the casing to which the proximal end of the
electrode lead is electrically and mechanically coupled, because Osypka's
casing 2 is configured to deliver stimulating pulses that propagate from the
interior of the casing 2 toward the surface 5a, as required by claim 16. Thus,
we determine that Osypka discloses the limitations of claim 23, and our
findings with respect to claim 1 supra are also applied to claim 23 to the
extent claim 23 recites similar limitations as recited in claim 1.
Accordingly, we enter a NEW GROUND OF REJECTION of
independent claim 23 under 3 5 U.S. C. § 102 (b) as anticipated by Osypka.
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Dependent claims 16. 3 5. 3 7. and 3 9
Claim 16, which depends from independent claim 13, further requires,
in relevant part, "mechanically and electrically coupling a proximal end of
the lead to the medical device, the medical device being configured to
generate electrical stimulation and deliver the electrical stimulation to the
patient via the at least one stimulation electrode of the lead." Appeal Br. 44
(Claims App.). Claims 35, 37, and 39, which depend from independent
claims 1, 13, and 23, respectively, more specifically require, in relevant part,
that the mechanically and electrically coupling of the lead's proximal end to
the medical device is a direct mechanical coupling to the medical device or
to the stimulator. Appeal Br. 48 (Claims App.).
We rely on the Examiner's findings, which are undisputed by
Appellant, with respect to Osypka, in that the Examiner finds Osypka
discloses the limitations of claims 16, 35, 37, and 39. Final Act. 9-11
(citing Osypka 4:6-14, 51-52, Fig. 1); see also Appeal Br. 25 (arguing that
claims 16, 35, 37, and 39 are patentable based on their dependence on claim
1 and the arguments presented by Appellant for the patentability of claim 1 ).
Indeed, Osypka discloses, with reference to Figures 1 to 3, that "cardiac
pacemaker system ... comprises a casing 2 serving to accommodate an
energy source and electronic pulse generating components" and that
"electrode lead 1 includ[ es] a flexible conductor lA having a first end
portion la coupled to the casing and a second end portion 3 distal from the
casing 2 and having a substantially hemispherical head S provided with an
exposed stimulation surface Sa." Osypka 4:6-14. Osypka also discloses
that stimulating pulses propagate in the direction "from the interior of the
casing 2 toward the surface Sa" (id. at 4:22-23) and that "surface Sa is in an
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optimum position for transmission of pulses to the adjacent portion of the
heart." Id. at 4:51-52. Thus, Osypka discloses that the proximal or first end
portion 1 a of flexible conductor 1 A is mechanically and electrically coupled
to the medical device or casing 2, which is configured to generate and
deliver electrical stimulation to the patient via the stimulation electrode (i.e.,
head 5), as recited in claim 16, and further, inherently discloses that such a
coupling is direct and that such pulses from the interior of casing 2 are
generated by a stimulator.
Accordingly, we enter a NEW GROUND OF REJECTION of claims
16, 35, 37, and 39 under 35 U.S.C. §102(b) as anticipated by Osypka.
(ii) Unpatentable over Osypka: claims 10 and 11
(Relating to Original Rejection II)
Claims 10 and 11, which depend from independent claim 1, recite, in
relevant part, certain ranges for the pitch and height of adjacent threads of
the threaded fixation structure. Appeal Br. 42--43 (Claims App.).
We rely on the Examiner's determination that the pitch and height of
threads of a fixation structure for implanted medical devices are recognized
in the prior art as result-effective variables. Final Act. 7-8; see, e.g., Osypka
3: 3 6--46 ( evidencing that the prior art recognizes that thread height for a
threaded fixation structure of an implantable medical device may vary, for
example, to facilitate introduction of the anchoring means ... during
implantation of the electrode lead"); Cates ,r 92 ( evidencing that the prior art
recognizes that pitch for "any helical or screw-like structure" may be
uniform or non-uniform, or tapering). We reason that it would have been
obvious to one of ordinary skill in the art at the time of the invention to
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modify thread 6 of Osypka's threaded fixation structure (as discussed supra
with respect to independent claim 1) to have pitches and heights within the
claimed ranges because the prior art recognizes pitch and height of threaded
fixation structures as result-effective variables, and it is not inventive to
discover the optimum or workable ranges by routine experimentation.
Accordingly, we enter a NEW GROUND OF REJECTION of claims
10 and 11 under 35 U.S.C. § 103(a) as unpatentable over Osypka.
(iii) Unpatentable over Osypka and Cates: claims 7, 14, 15, and 18-20
(Relating to Original Rejection IV)
Claims 7, 14, 15, and 18-20 depend from independent claims 1 and
13, and recite, in relevant part, (i) "a sheath configured to cover at least the
portion of the outer surface of the elongated member" (i.e., the portion of the
outer surface around which the threaded fixation structure extends)
"including the at least one threaded fixation structure, wherein the at least
one threaded fixation structure is configured to fold in one direction to allow
that at least one threaded fixation structure to lie against the elongated
member when restrained by the sheath" ( claim 7); (ii) the step of "removing
a sheath from the lead to expose the at least one threaded fixation structure
after the lead is inserted into the patient" ( claim 14); (iii) "wherein removing
the sheath allows the at least one threaded fixation structure to unfold and
extend from the lead" ( claim 15); the step of (iv) "sliding a sheath over the
lead to cover the at least one threaded fixation structure with the sheath"
( claim 18); ( v) the step of "removing the lead and sheath from the patient"
( claim 19); and (vi) the step of "inserting the medical lead into a patient
compris[ing] forcing the at least one threaded fixation structure to fold down
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against the outer surface of the lead in a first direction" ( claim 20). Appeal
Br. 42--44 (Claims App.).
We rely on the Examiner's findings that Cates teaches a sheath that
operates relative to a foldable fixation structure, as claimed. Final Act. 13-
17 ( citations omitted). Indeed, Cates discloses inserting lead 241 into a
patient, and after sheath 320 is at the desired location within the tissue,
retracting sheath 320 from electrode 230 and lead body 240 to permit
fixation elements 232, 234 to expand and affix the electrode 230 within the
tissue. Cates ,r 54.
We also rely on the Examiner's reasoning that it would have been
obvious to modify Osypka's electrode lead 1 to include a sheath, as taught
by Cates, to "provide the predictable results of easier device insertion which
minimizes the device (fixation elements) getting caught on tissue during
insertion." Final Act. 14--17. In support, Osypka discloses that "the
anchoring means comprises a screw which consists, at least in part, of a
yieldable soft material capable of undergoing deformation during
introduction into and travel through narrow openings or interstices of the
trabecular network in response to rotation of the screw." Osypka 2:50-56.
Osypka also recognizes that deformability of thread 6 "reduces the
likelihood of damage to the vein during implantation of the lead 1," and to
surrounding tissue. Id. at 5:58---64. Thus, consistent with the Examiner's
findings and reasoning, it would have been obvious to one of ordinary skill
in the art, at the time of the invention, to modify Osypka' s electrode lead 1
with yieldable thread 6 to include a sheath, as taught by Cates, to allow lead
1 to be positioned closer to the target tissue area before exposing thread 6 by
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removing via sliding of the sheath to reduce potential damage to the tissue
during implantation of the lead.
With respect to the Examiner's reliance on Cates in Rejection IV,
Appellant argues that
given the fact that a person having ordinary skill in the art would
consciously have avoided modifying Osypka in view of Hastings
in the manner proposed by the Examiner, a person of ordinary
skill in the art would have had no apparent reason to modify
Osypka's system to include 'a sheath[],' as recited in claim 7.
Appeal Br. 28-29 (presenting the same argument with respect to claims 14,
15, and 18-20). However, Appellant's argument does not apprise us of
factual errors based on Cates, nor does Appellant's argument address the
Examiner's reasoning supra, which we adopt in the context of this new
ground of rejection.
Accordingly, we apply Osypka to claim 1 as set forth supra, and enter
a NEW GROUND OF REJECTION of claims 7, 14, 15, and 18-20 under 35
U.S.C. §103(a) as unpatentable over Osypka and Cates.
(iv) Unpatentable over Osypka and Okajima: claims 8 and 9
(Relating to Original Rejection VJ
Claim 8, which depends from independent claim 1, recites, in relevant
part, "a helical reinforcement member disposed within an inner surface of
the elongated member to provide torsional rigidity to the elongated
member," and claim 9, which depends from claim 8, recites, in relevant part,
"wherein the at least one threaded fixation structure extends around the
portion of the outer surface of the elongated member in a first direction, and
wherein the helical reinforcement member is disposed in a second direction
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different than the first direction of the at least one threaded fixation
structure." Appeal Br. 42 (Claims App.).
We rely on the Examiner's findings that Okajima teaches that "it is
known to use an inner coil wound in a clockwise direction and an outer coil
wrapped in a counterclockwise direction ... to impart excellent torque
transmission ability and anti-kink characteristics" to a catheter, as claimed.
Final Act. 18 ( citing Okajima 14: 18-21, Fig. 2). Indeed, Okajima is
specifically concerned with "pushability" and "torque transmissionability"
of a catheter (i.e., the characteristics of a catheter that can reliably transmit
pushing and rotational forces applied at the base end of the catheter,
respectively, to distal end), in addition to kink resistance (i.e., the ability of
the catheter to prevent bending). Okajima 1 :54--2:4. For this purpose,
Okajima discloses that it is known to have "a helically wound wire which is
provided inside the catheter." Id. at 2:56-57. Okajima also discloses that
[b ]y constructing the coil layer 8 from the two coils wound in
opposite directions[], it is possible to obtain an excellent torque
transmission ability when an operator turns the catheter 1 by
operating its proximal end irrespective of the rotational direction
( clockwise or counterclockwise). Furthermore, compared to a
one coil (single coil) structure, the two coil structure can have
more excellent anti-kink characteristics and is far more efficient
for preventing the lumen from being pressed.
Okajima 14:36-44, Fig. 2 (emphasis added).
Thus, it would have been obvious to one of skill in the art, at the time
of the invention, to modify axial passage 9 of Osypka' s flexible conductor
IA to have a helical reinforcement member, such as a coil, as taught by
Okajima, within an inner surface of axial passage 9, and further, to arrange
the direction of the coil in a direction that is different from the direction of
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thread 6 to benefit from the pushability, torque transmissionability, and kink
resistance that results from such a configuration, as taught by Okajima. See
Final Act. 18. Notably, similar to Okajima's catheter insertion within a
patient, Osypka discloses "driv[ing] screw 4 home by rotating the entire
electrode lead 1." Osypka 4:67-68; see also Osypka 1 :67-2:4 ("Another
object of the invention is to provide an electrode lead for establishment of an
intravenous connection between the casing of a cardiac pacemaker and the
heart which is constructed and assembled in such a way that it can
adequately anchor its head and the stimulation surface thereon in an
optimum position in the selected portion of the heart without injuring the
heart wall.").
We are not persuaded by Appellant's argument, addressing claims 8
and 9 pursuant to Rejection V supra, that Osypka's electrode lead "lacks a
nexus" to the Examiner's modification, because, similar to Okajima's
catheter, Osypka is concerned with advancing an electrode lead within a
patient to a target site. See Appeal Br. 31; Osypka 1:67-2:4, 4:67---68. We
are also not persuaded by Appellant's argument that Okajima describes an
intermediate layer 12 around the outside of the inner layer 6, but does not
disclose an outer coil wrapped in a counterclockwise direction, such that the
Examiner's proposed modification lacks support. Appeal Br. 31-32.
However, Osypka's threaded fixation structure is relied on for providing the
structure of threads 6, or an outer coil, as set forth supra.
Accordingly, we apply Osypka to claim 1 as set forth supra, and enter
a NEW GROUND OF REJECTION of claims 8 and 9 under 35 U.S.C.
§103(a) as unpatentable over Osypka and Okajima.
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(v) Unpatentable over Osypka and Doan: claim 12
(Relating to Original Rejection VJ)
Claim 12, which depends from independent claim 1, recites, in
relevant part, "wherein the at least one threaded fixation structure comprises
at least one of a biocompatible metal alloy and a biocompatible polymer."
Appeal Br. 43 (Claims App.).
We rely on the Examiner's determination that Doan teaches "that it is
known to use a threaded fixation structure made of biocompatible metallic
alloy," as required by claim 12, and on the Examiner's reasoning that it
would have been obvious to one skilled in the art at the time of the invention
to modify Osypka's threaded fixation structure to be made ofbiocompatible
metal alloy, as taught by Doan, to provide "improved acceptance by the
body without harming the patient." Final Act. 19 (citing Doan 4:24--26)
( disclosing that the helix electrode "may be made of a platinum-iridium
alloy or similar biocompatible metal or metallic alloy").
With respect to the Examiner's reliance on Doan in Rejection VI
supra, Appellant argues that
Doan fails to overcome the deficiencies of Osypka in view of
Hasting discussed . . . with respect to claim 1, and there would
have had no apparent reason that would have caused one of
ordinary skill in the art to modify Osypka' s system in view of
Hastings and further in view of Doan to arrive at the subject
matter recited in claim 12.
Appeal Br. 32. However, Appellant's argument does not apprise us of
factual errors based on Doan, nor does Appellant's argument address the
Examiner's reasoning supra.
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Accordingly, we apply Osypka to claim 1 as set forth supra, and enter
a NEW GROUND OF REJECTION of claims 12 under 35 U.S.C. § 103(a)
as unpatentable over Osypka and Doan.
(vi) Unpatentable over Osypka, Cates, and Wittkampf claim 21
(Relating to Original Rejection VII)
Claim 21, which depends from claim 20, which depends from
independent claim 13, recites, in relevant part, the further step of "pulling
the lead in the first direction to extend the at least one threaded fixation
structure into the tissue, and wherein rotating the lead causes the at least one
threaded fixation structure to advance the lead in a second direction opposite
to the first direction." Appeal Br. 45 (Claims App.).
We rely on the Examiner's finding that Wittkampf teaches that "it is
known to use pulling the lead in a backward direction, toward the proximal
end, to extend the at least one threaded fixation structure into the tissue," as
claimed, and on the Examiner's reasoning that it would have been obvious to
one skilled in the art at the time of the invention to modify Osypka's method
of fixing an electrode lead in tissue via a threaded fixation structure by
pulling the lead in a backward direction, as claimed, and as taught by
Wittkampf, in addition to advancing the lead via the thread 6 as taught to
Osypka. Final Act. 19-20 (citing Wittkampf 3:25-53) (disclosing a method
of fixing a lead to the epicardium "by placing the lead head on or near the
surface of the epicardium and pulling the entire lead in a backward direction,
toward the proximal end thereof').
With respect to the Examiner's reliance on Wittkampf in Rejection
VII supra, Appellant argues that
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given the fact that a person having ordinary skill in the art would
consciously have avoided modifying Osypka in view of Hastings
in the manner proposed by the Examiner, a person of ordinary
skill in the art would have had no apparent reason to arrive at the
method[], as recited in claim 21.
Appeal Br. 33. However, Appellant's argument does not apprise us of
factual errors based on Wittkampf, nor does Appellant's argument address
the Examiner's reasoning supra.
Accordingly, we apply Osypka to claim 1 as set forth supra, and enter
a NEW GROUND OF REJECTION of claim 21 under 35 U.S.C. § 103(a) as
unpatentable over Osypka, Cates, and Wittkampf.
(vii) Unpatentable over Osypka and Whitehurst: claim 22
(Relating to Original Rejection Vfll)
Claim 22, which depends on independent claim 13, recites in relevant
part, the step of "positioning the at least one electrode adjacent to at least
one of a sacral nerve a prudendal nerve, a spinal cord, and an occipital
nerve." Appeal Br. 45 (Claims App.).
We rely on the Examiner's finding that Whitehurst teaches that "it is
known to use an electrode placed adjacent to the occipital nerve ... to
provide treatment for occipital neuralgia," and the Examiner's reasoning that
it would have been obvious to modify Osypka's method "with placing the
electrode near the occipital nerve," as taught by Whitehurst, because "such a
modification would provide the predictable results of treating occipital
neuralgia." Final Act. 20 (citing Whitehurst ,r 91) (disclosing a treatment
modality for neuralgia, including implanting electrodes adjacent occipital
nerves).
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With respect to the Examiner's reliance on Whitehurst in Rejection
VIII supra, Appellant argues that "the Examiner failed to show that a person
having ordinary skill in the art would have had any reason to modify
Osypka' s method to include positioning the at least one electrode, as
claimed," and that "the Examiner's rationale for the modification ...
appears to be the end result of the modification itself, i.e., 'treating occipital
neuralgia."' Appeal Br. 34. In other words, Appellant contends that the
Examiner has not established that one of ordinary skill in the art would have
recognized "using an intravenously implantable cardiac lead having an
anchoring means configured to retain the lead within the trabecular network
of a heart to treat occipital neuralgia." Id. Appellant concludes that the
Examiner impermissibly relied on hindsight. Id.
We are not persuaded by Appellant's argument. Although Osypka
discloses that its intravenously implantable electrode lead is preferably used
in conjunction with a cardiac pacemaker, Osypka acknowledges that "other
can, by applying current knowledge, readily adapt [ the invented electrode
lead] for various applications." Osypka 8:7-9.
Accordingly, we apply Osypka to claim 1 as set forth supra, and enter
a NEW GROUND OF REJECTION of claim 22 under 35 U.S.C. § 103(a) as
unpatentable over Osypka and Whitehurst.
(viii) Unpatentable over Osypka and Mamo: claims 36, 38, and 40
(Relating to Original Rejection );_1ll)
Claims 36, 38, and 40, which depend from independent claims 1, 13,
and 23, respectively, recite, in relevant part, that the coupling of the
proximal end of the elongated member is to the medical device is via a lead
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extension. Appeal Br. 48 (Claims App.). For example, the Specification
discloses that "[p ]roximal end 14A of lead 14 may be both electrically and
mechanically coupled to connector 13 of stimulator 12 either directly or via
a lead extension." Spec. ,r 31.
We rely on the Examiner's finding that Mamo teaches that it is known
to configure the coupling of the proximal end of an elongated member to a
medical device via a lead extension (i.e., lead extension 32) "to reduce the
risk of disconnection or lead migration." Final Act. 25 ( citing Mamo, Fig.
2); see also Mamo ,r 71 (disclosing that, with reference to Figure 3g, "[a]
neurostimulation system can include a stimulation lead 30, ... a lead
extension 32, and a trial stimulator (not shown)" wherein "lead extension 32
connects between the stimulation lead 30 and the trial stimulator"); see also
id., Fig. 2 (lead extension 32). We also rely on the Examiner's reasoning
that it would have been obvious to modify the proximal end of Osypka's
elongated member to couple to casing 2 (and the stimulator) via a lead
extension, as taught by Mamo, "[to] reduce the risk of disconnection." Final
Act. 25. We further reason that such a modification is the mere substitution
of one known method for connecting implantable electrode components (i.e.,
an indirect connection via a lead extension) for another known method (i.e.,
a direct connection), and note that where "a patent claims a structure already
known in the prior art that is altered by the mere substitution of one element
for another known in the field, the combination must do more than yield a
predictable result." In re Mouttet, 686 F.3d 1322, 1331 (Fed. Cir. 2012)
(citing KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007)).
With respect to the Examiner's reliance on Mamo in Rejection XIII
supra, Appellant fails to present any specific arguments in favor of
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patentability, for example, apart from those arguments presented in the
rejection of the independent claims supra. Appeal Br. 37-38.
Accordingly, we apply Osypka to claim 1 as set forth supra, and enter
a NEW GROUND OF REJECTION of claims 36, 38, and 40, under 35
U.S.C. §103(a) as unpatentable over Osypka and Mamo.
DECISION
The Examiner's rejection of claims 10, 11, 31, and 32 under 35 U.S.C.
§ 112, second paragraph, as indefinite is AFFIRMED.
The Examiner's rejection of Claims 1, 4-23, and 35-40 under 35
U.S.C. § 103(a) as unpatentable over Osypka and Hastings, or in further
view of Cates, Okajima, Wittkampf, Whitehurst, and/or Mamo is
REVERSED.
The Examiner's rejection of claims 24--33 under 35 U.S.C. § 103(a) as
unpatentable over Gerber and Hastings, and in further view of Hansmann,
Cates, Okajima, and/or Doan is AFFIRMED.
We enter NEW GROUNDS OF REJECTION of: (i) claims 1, 13, 16,
17, 23, 35, 37, and 39 under 35 U.S.C. § 102(b) as anticipated by Osypka;
(ii) claims 10 and 11 under 35 U.S.C. §103(a) as unpatentable over Osypka;
(iii) claims 7, 14, 15, and 18-20 under 35 U.S.C. § 103(a) as unpatentable
over Osypka and Cates; (iv) claims 8 and 9 under 35 U.S.C. § 103(a) as
unpatentable over Osypka and Okajima; (v) claim 12 under 35 U.S.C.
§103(a) as unpatentable over Osypka and Doan; (vi) claim 21 as
unpatentable over Osypka, Cates, and Wittkampf; ( vii) claim 22 as
unpatentable over Osypka and Whitehurst; and (viii) claims 36, 38, and 40
as unpatentable over Osypka and Mamo.
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FINALITY OF DECISION
This decision contains new grounds of rejection as permitted under 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 41.50(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
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 Manual of Patent Examining Procedure§ 1214.01.
35
Appeal2017-007836
Application 11/ 591, 171
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART; 37 C.F.R. § 4I.50(b)
36