Boston Scientific Neuromodulation Corporation

Patent Trials and Appeals Board

Dec 3, 2021

2020006116 (P.T.A.B. Dec. 3, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/468,973 03/24/2017 Ishmael Bentley BSNC-1-290.2 7157
50638 7590 12/03/2021
Boston Scientific Neuromodulation Corp.
c/o Branch Partners PLLC
600 University Street, Suite 620
Seattle, WA 98101
EXAMINER
PLIONIS, NICHOLAS J
ART UNIT PAPER NUMBER
3773
NOTIFICATION DATE DELIVERY MODE
12/03/2021 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):
patentdocketing@branchpartners.law
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ISHMAEL BENTLEY, DALE BRADY, EMILY DALEY,
MICHAEL E. LANCIAL, LAWRENCE W. WALES, and
STEVEN L. GRIFFITH
Appeal 2020-006116
Application 15/468,973
Technology Center 3700
Before JENNIFER D. BAHR, CHARLES N. GREENHUT, and
ANNETTE R. REIMERS, Administrative Patent Judges.
REIMERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 9–24, 27, and 28.2 Claims 1–8 have
been canceled. We have jurisdiction under 35 U.S.C. § 6(b).

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Boston Scientific
Neuromodulation Corporation. Appeal Brief (“Appeal Br.”) 2, filed Apr. 7,
2020.
2 The Examiner indicates that “[c]laims 25 and 26 are objected to as being
dependent upon a rejected base claim, but would be allowable if rewritten in
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We AFFIRM IN PART.
CLAIMED SUBJECT MATTER
The claimed subject matter relates to “[a] method[] for securing
implantable medical devices to bony structures and soft tissues of a patient.”
Spec. ¶ 1. Claim 9, the sole independent claim on appeal, is representative
of the claimed subject matter and recites:
9. A method of securing a neurostimulation lead in soft tissue of
a patient, the method comprising:
providing the neurostimulation lead and an anchoring
sleeve that is separate from the neurostimulation lead;
sliding the anchoring sleeve onto the neurostimulation
lead and positioning the anchoring sleeve around a portion of the
neurostimulation lead in the patient;
positioning an adjustable loop of a suture assembly around
the anchoring sleeve;
embedding at least one tissue anchor within the soft tissue
of the patient, wherein the at least one tissue anchor is attached
to the suture assembly; and
tightening the adjustable loop to secure the
neurostimulation lead in the soft tissue of the patient using the at
least one tissue anchor.

REJECTION
I. Claims 9–24, 27, and 28 stand rejected under pre-AIA 35 U.S.C.
§ 103(a) as unpatentable over Kane (US 2011/0009935 A1, published Jan.
13, 2011) and Bentley (US 2009/0259260 A1, published Oct. 15, 2009).

independent form including all of the limitations of the base claim and any
intervening claims.” Non-Final Office Action (“Non-Final Act.”) 6, dated
Dec. 27, 2019; see also Appeal Br. 4; Reply Brief (“Reply Br.”) 2, filed
Aug. 25, 2020. Claims 25 and 26 are not part of the instant appeal.
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ANALYSIS
Claims 9–18, 20–24, 27, and 28
Appellant presents arguments for claim 9 and relies on the same
arguments for claims 10–18, 20–24, 27, and 28. See Appeal Br. 4–8. We
select claim 9 as the representative claim, and claims 10–18, 20–24, 27, and
28 stand or fall with claim 9. See 37 C.F.R. § 41.37(c)(l)(iv). We address
claim 19 separately below.
The Examiner finds that Kane discloses the method of claim 9
including “using an adjustable loop of suture to secure the lead to soft tissue
in a patient.” Non-Final Act. 3 (citing Kane ¶¶ 26, 49); see also id. at 2.
However, the Examiner finds that Kane “fails to disclose positioning an
adjustable loop of a suture assembly around the anchoring sleeve with at
least one tissue anchor attached to the suture assembly” as well as
“tightening the adjustable loop to secure the neurostimulation lead in the soft
tissue of the patient using the at least one tissue anchor embedded in soft
tissue of a patient.” Non-Final Act. 2–3; see also Appeal Br. 10 (Claims
App.).
The Examiner turns to the teachings of Bentley for these limitations.
In particular, the Examiner finds that “Bentley discloses a method of
securing a medical implant in soft tissue of a patient, wherein the method
includes positioning an adjustable loop (812) of a suture assembly (810)
around a medical implant (811/600), at least one tissue anchor (814) being
attached to the suture assembly” and “tightening the adjustable loop to
secure the medical implant in the soft tissue of the patient using the at least
one tissue anchor embedded in soft tissue of a patient.” Non-Final Act. 3
(citing Bentley ¶¶ 227, 245).
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The Examiner reasons that it would have been obvious to an
ordinarily skilled artisan “to modify the method of Kane [with] the
anchoring method suggested by Bentley to anchor the neurostimulation lead
to soft tissue[,] as Bentley suggests its anchoring element is suitable for use
in securing an implant to soft tissue” and as “such a modification merely
involves substituting one known anchoring element from a known method of
securing an implantable medical device for another known anchoring
element from another known method of securing an implantable medical
device without any unpredictable results.” Non-Final Act. 6 (citing Bentley
¶¶ 139, 228).
Appellant contends “Bentley does not disclose that ‘the method
includes positioning an adjustable loop (812) of a suture assembly (810)
around a medical implant (811/600)’” in that “elongate member 812 [of
Bentley] is not positioned around [] patch 600, [as asserted] in the Office
Action.” See Appeal Br. 5–8; see also Reply Br. 6–11. In the Answer, the
Examiner clarifies that “Bentley’s use of an eyelet to attach [a] suture to an
implant [is not relied upon by the Examiner], as Kane already discloses
attaching[/positioning] [a] suture to the implant by having the suture looped
around the outside of a medical implant.” Ans. 9 (citing Kane Abstract).3,4

3 Examiner’s Answer (“Ans.”), dated July 1, 2020.
4 Incidentally, we note that adjustable loop 816 of tissue anchor assembly
814, 815 of Bentley is positioned around patch/medical implant 600. See
Bentley Fig. 66; In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972) (“[T]hings
patent drawings show clearly are [not] to be disregarded.”) (emphasis in
original).

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Indeed, Kane discloses “[a] reinforced suture sleeve 10 [] comprised
of an internal insert 18,” wherein “[a] polymeric body 30 is molded over the
circumference of the insert 18, encompassing the insert 18 within” and “[a]
series of at least two suture grooves 32 are cut into the outer surface of the
polymeric body 30 [to] circumferentially extend around the polymeric body
30.” Kane ¶¶ 43, 49; see also id. ¶ 26 (Kane disclosing that “[a] polymer,
preferably silicone, is molded over the insert to provide the body of the
suture sleeve structure around which the suture material is wrapped” and
“[g]rooves in the outside surface of the over molded polymer body provide a
‘track’ to keep the suture material in place as it is wrapped circumferentially
around the sleeve body.”); Non-Final Act. 3 (citing Kane ¶¶ 26, 49). In the
Reply Brief, Appellant does not refute the Examiner’s clarification in the
Answer that Kane discloses this limitation. See Reply Br., passim.
Appellant contends “the assertion that Bentley discloses securing ‘a
medical implant’ is overgeneralized as Bentley only discloses bone anchors
and the patch or patch-like device.” Appeal Br. 5; see also Reply Br. 3.
According to Appellant, the Examiner “overinflates the [teachings] of
Bentley to support the conclusion of obviousness instead of viewing the
teachings of Bentley from the perspective of one of ordinary skill in the art”
as “[t]here is no teaching in Bentley of the general category of medical
implants, but rather Bentley is directed to very specific implants for a
specific purpose – the repair of the annulus of a disc.” Appeal Br. 5; see
also Reply Br. 3; id. at 4–5 (Appellant arguing that “Bentley does not teach
or suggest the overgeneralized category of ‘medical implants’ but is very
specific in its teachings.”).
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Appellant further contends that “one of skill in the art, absent the
knowledge of the Appellant’s patent application, would not be motivated to
combine Bentley and Kane.” Reply Br. 5. In particular, Appellant contends
that “[t]he fixation apparatus and suture assembly of Bentley are used for a
very different function in Bentley; namely, the repair of the annulus of a
disc,” that “[t]he fixation apparatus and suture assembly of Bentley are used
in a very different way in Bentley; namely drawing the annulus toward the
bone in which the bone anchor is lodged,” and that “[t]he fixation apparatus
and suture assembly of Bentley achieves a very different result in Bentley;
namely the repair of an existing physiological element (the annulus of the
disc) using an arrangement that draws that physiological element toward a
second physiological element (the bone).” Reply Br. 5; see also id. at 10
(Appellant arguing that “the function of the fixation apparatus and suture
assembly of Bentley, the way Bentley uses the fixation apparatus and suture
assembly of Bentley, and the result of the use of the fixation apparatus and
suture assembly of Bentley are entirely different from the fixation of a lead
in Kane.”); id. at 11.
As an initial matter, although not entirely clear from Appellant’s
argument as stated, to the extent Appellant is arguing that Bentley is
non-analogous art, this contention is unpersuasive. The Federal Circuit has
laid out two separate tests to determine whether a reference is analogous art
to the claimed invention, i.e., whether one of ordinary skill in the art would
even look to the teachings of Bentley. In re Bigio, 381 F.3d 1320, 1325
(Fed. Cir. 2004). They are: “(1) whether the art is from the same field of
[the inventor’s] endeavor” and “(2) if the reference is not within the field of
the inventor’s endeavor, whether the reference still is reasonably pertinent to
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the particular problem with which the inventor is involved.” Id.; see also In
re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011).
The subject invention is directed to “devices and methods for securing
implantable medical devices to bony structures and soft tissues of a patient.”
Spec. ¶ 1. Similarly, Bentley is directed to “implantable medical devices”
and methods for securing those implantable medical devices to bony
structures and soft tissues of a patient. See, e.g., Bentley ¶¶ 14, 15, 17.
Referring to Figure 66 of Bentley, referenced by both Appellant and the
Examiner, Bentley discloses an implantable medical device, i.e., patch 600,
which is secured to a bony structure, i.e., vertebral body 202, and soft tissue,
i.e., annulus fibrosis 232, of a patient via bone anchor 811, elongate member
812 and associated tether 812a in conjunction with a tissue anchor assembly,
i.e., tissue anchor 814 having a T-anchor 815 with elongate element 816.
See Bentley ¶ 245, Fig. 66; see also id. ¶¶ 204, 205, 227–229, Figs. 49, 50;
Appeal Br. 5–6; Reply Br. 3–6; Non-Final Act. 3. Because Bentley
discloses implantable medical devices and methods for securing those
implantable medical devices to bony structures and soft tissues of a patient,
we find that Bentley is from the same field of endeavor as that of the
inventor. Additionally, as bone anchor 811 and tissue anchor assembly 814,
815, 816 of Bentley secure implantable patch 600 to respective vertebral
body 202 and annulus fibrosis 232 of a patient, we disagree with Appellant
that “[t]he fixation apparatus and suture assembly of Bentley are used for a
very different function in Bentley.” Reply Br. 5.
In this case, the Examiner is merely looking to the teachings of
Bentley for disclosure of “an alternative soft tissue anchoring method.” See
Ans. 8–10 (emphasis added); see also Non-Final Act. 3–6. In fact, the
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Examiner clarifies in the Answer that “Kane suggests using [a] suture
wrapped around the lead and sewn into soft tissue to attach the lead to soft
tissue” and “Bentley suggests an alternative soft tissue anchoring method
using an adjustable loop and tissue anchor . . . that can be substituted for
simple wrapping of suture around the implant and sewing of the suture into
soft tissue, without the substitution causing any unpredictable results.” Ans.
9 (emphasis added) (citing Kane Abstract, ¶¶ 6, 64; Bentley ¶¶ 139, 228);
see also id. at 8. The Examiner also points out that “Bentley suggests its soft
tissue anchoring method reduces the time and skill versus sewing and
knotting.” Ans. 9 (citing Bentley ¶ 109); see also id. at 8. As such, the
Examiner reasons that “a person of ordinary skill in the art would find it
obvious to substitute one known, suitable soft tissue suture anchoring
method for another known, suitable soft tissue suture anchoring method,
especially if it reduces the time and skill needed to anchor the lead in soft
tissue.” Id. at 9–10.
Appellant does not provide any persuasive reasoning or evidence to
suggest that Bentley’s fixation apparatus and suture assembly are unsuitable
for use with the neurostimulation lead of Kane. Appeal Br. 4–8; see also
Reply Br. 2–11. Both the suture of Kane and the fixation apparatus and
suture assembly of Bentley are directed towards anchoring medical implants
to tissue. Kane ¶ 6; Bentley ¶¶ 228, 245, Figs. 49, 50, 66. Absent any
evidence that would suggest otherwise, the fixation apparatus and suture
assembly taught by Bentley would be a suitable alternative method of
anchoring the neurostimulation lead of Kane. See Ans. 7–8 (The Examiner
stating that “Appellant does not explain why one of ordinary skill in the art
would be dissuaded from utilizing the [medical implant] soft-tissue
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anchoring techniques of Bentley [in place of] other types of medical
implant[]” soft-tissue anchoring techniques.).
We also are not persuaded the Examiner engages in impermissible
hindsight in combining the teachings of the references. See Appeal Br. 4–8;
see also Reply Br. 2–11. The Examiner cites specific teachings in Kane and
Bentley themselves, not Appellant’s disclosure, in support of the Examiner’s
articulated reasoning for combining Kane and Bentley as proposed in the
rejection. See Non-Final Act. 3–6; see also Ans. 8–10. We further are not
persuaded of Examiner error, because Appellant does not make a showing
that the Examiner’s rationales are outside of the knowledge within the level
of ordinary skill in the art at the time the claimed invention was made or are
gleaned only from Appellant’s disclosure.
Consequently, for the above reasons, Appellant does not apprise us of
Examiner error in the combined teachings of Kane and Bentley.
Accordingly, we sustain the Examiner’s rejection of claim 9 as unpatentable
over Kane and Bentley. We further sustain the rejection of claims 10–18,
20–24, 27, and 28, which fall with claim 9.

Claim 19
Claim 19 depends from claim 18 and recites “wherein advancing the
neurostimulation lead and anchoring sleeve [through the adjustable loop]
occurs after embedding the at least one tissue anchor within the soft tissue of
the patient.” Appeal Br. 11 (Claims App.). The Examiner finds that
“paragraph 243 of Bentley is relied on for suggesting that the order of
operations for placing the anchors does not matter such that the tissue anchor
can be placed prior to attachment of the suture to the implant. Thus, the
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prior [art] suggests all of the features of claim 19.” Ans. 11; see also Non-
Final Act. 4.
Paragraph 243 of Bentley discloses the use of a delivery tool for
delivering tissue and/or bone anchors and further discloses that “it is
conceivable to have multiple anchors capable of being anchored to bone as
well as multiple soft tissue anchors in one tool, with the order of delivery not
expressed as illustrated in FIG. 65, but workable in the opposite order, or in
a different fashion.” Bentley ¶ 243.
Based on the above-quoted portion of paragraph 243 of Bentley, we
acknowledge the Examiner’s position that “the tissue anchor can be placed
prior to attachment of the suture to the implant.” See Ans. 11; see also Non-
Final Act. 4. However, the Examiner also relies on paragraph 243 of
Bentley for disclosure of “positioning the adjustable loop of a suture
assembly around the medical implant comprises advancing the implant
through the adjustable loop.” Non-Final Act. 4 (citing Bentley ¶ 243).
There is no discussion in paragraph 243 of Bentley about advancing the
implant through the adjustable loop, let alone that this advancement occurs
after embedding the at least one tissue anchor within the soft tissue of the
patient. See Reply Br. 13 (Appellant arguing that “paragraph 243 of Bentley
is not relevant because [it] does not teach advancing the medical implant
into the adjustable loop and, therefore . . . does not provide any insight into
the order of steps recited in claim 19.”); see also Appeal Br. 8.
Accordingly, for these reasons, we do not sustain the Examiner’s
rejection of claim 19 as unpatentable over Kane and Bentley.5

5 Appellant also contends that “[c]laim 19 depends from claim 18 which
depends from claim 9. Claim 19 is patentable over the cited references for at
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CONCLUSION
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
9–24, 27, 28 103(a) Kane, Bentley 9–18, 20–
24, 27, 28
19
RESPONSE
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)(1)(iv).
AFFIRMED IN PART

least the same reasons [presented for] claim 9.” Appeal Br. 8; Reply Br. 11.
For the same reasons discussed above in reference to claim 9, Appellant’s
argument is not persuasive.