Ex Parte Boyd et al

Patent Trials and Appeals Board

Mar 27, 2019

14342984 - (D) (P.T.A.B. Mar. 27, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/342,984 03/05/2014
99097 7590
Hoffmann and Baron, LLP
6900 Jericho Turnpike
Syosset, NY 11791
03/27/2019
FIRST NAMED INVENTOR
Lawrence M. Boyd
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.
1487-54 PCT/US 8002
EXAMINER
BEHRINGER, LUTHER G
ART UNIT PAPER NUMBER
3793
MAIL DATE DELIVERY MODE
03/27/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LA WREN CE M. BOYD, MARK W. BENDER,
and MATTHEW PENNY 1
Appeal2018-004656
Application 14/342,984
Technology Center 3700
Before: STEP AN ST AI CO VICI, LEE L. STEPINA, and
ARTHUR M. PESLAK, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's final
decision rejecting claims 19-25. 2 We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.
1 Appellants' Appeal Brief identifies Spine Wave, Inc. as the real party in
interest. Appeal Br. 1.
2 Claims 1-18 are withdrawn from consideration. Final Act. 1.
Appeal2018-004656
Application 14/342,984
CLAIMED SUBJECT MATTER
The claims are directed to a method of dilating bodily tissue and
monitoring neural activity in the dilated bodily tissue. Spec. ,r 2. Sole
independent claim 19, reproduced below, is representative of the claimed
subject matter:
19. A method of monitoring neural activity in bodily tissue,
comprising the steps of:
introducing a first dilator into bodily tissue, said first
dilator having a tubular body comprising electrically-insulative
material, said tubular body having a distal end, a proximal end, a
central longitudinal axis therethrough, and a plurality of axially
extending channels formed about a circumference thereof
extending from said proximal end towards said distal end, each
channel being formed to accommodate a probe, said distal end of
said first dilator being placed adjacent a target site;
attaching a probe to a neuromonitoring device capable of
electrifying said probe and monitoring nerve proximity;
introducing said probe sequentially into each of said
channels with a tip of said probe being placed adjacent and
exposed to said target site, electrifying the tip of said probe and
monitoring nerve activity at each channel, and removing said
probe from each channel thereafter;
providing a second dilator having a tubular body
comprising electrically-insulative material, said tubular body
having a distal end, a proximal end and a lumen having a central
longitudinal axis extending therethrough sized to permit said
second dilator to telescopically slide over said first dilator, a
plurality of axially extending channels being formed about a
circumference of said tubular body of said second dilator
extending from said proximal end towards said distal end, each
channel being formed to accommodate said probe;
telescopically sliding said second dilator axially over said
first dilator in overlapping relation, the central longitudinal axis
of said lumen being in coaxial alignment with the central
longitudinal axis of said first dilator with the distal end of said
second dilator being placed adjacent said target site; and
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Application 14/342,984
introducing said probe sequentially into each of said
channels of said second dilator with a tip of said probe being
placed adjacent and exposed to said target site, electrifying the
tip of said probe and monitoring nerve activity at each channel
of said second dilator, and removing said probe from each
channel thereafter.
Appeal Br. 10 (Claims App.).
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Smith
Sutton
Schmitz
Fatone
us 4,862,891
US 7,258,690 B2
US 2009/0018507 Al
US 2011/0208226 Al
REJECTIONS
Sept. 5, 1989
Aug. 21, 2007
Jan. 15,2009
Aug. 25, 2011
I. Claims 19-22 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Fatone and Smith.
II. Claims 23 and 24 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Fatone, Smith, and Schmitz.
III. Claim 25 is rejected under 35 U.S.C. § I03(a) as unpatentable
over Fatone, Smith, and Sutton.
OPINION
Rejection I
Appellants argue claims 19-22 as a group. Appeal Br. 5. We select
independent claim 19 as a representative claim, and claims 20-22 stand or
fall with claim 19. 37 C.F.R. § 4I.37(c)(l)(iv).
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Application 14/342,984
The Examiner finds that Fatone discloses many of the limitations of
claim 19 including a first dilator slidable over a second dilator, but that the
sliding is not telescopic sliding in an overlapping relation with central
longitudinal axes that are coaxially aligned. Final Act. 4--5. Nonetheless,
the Examiner finds that Smith teaches "telescoping sliding of the second
dilator, 21, over the first dilator, 20, [] in an overlapping relation" with
coaxial alignment of the central longitudinal axes. Final Act. 5 ( citing Smith
Fig. 1 ). The Examiner considers that it would have been obvious to a person
having ordinary skill in the art to combine the embodiments of Fatone
together as well as having the dilators coaxially aligned, because "a true
percutaneous method of cannulation would eliminate the need for surgical
cut-down often practiced with respect to cannulation of the femoral vein and
artery, thereby allowing a broader range of hospital based physicians to
implement the procedure." Final Act. 6. The Examiner concludes that
although Fatone and Smith fail to disclose a plurality of axially extending
channels on the second dilator, because Fatone discloses a plurality of
channels on the first dilator, adding them to the second dilator would be a
mere duplication of parts. Final Act. 6-7 (citing St. Regis Paper Co. v.
Bemis Co., 549 F .2d 833 (7th Cir. 1977).
Appellants argue that it is improper to combine the embodiments of
Fatone with Smith to reject claim 19 because Fatone teaches away from
Smith's concentric dilator. Appeal Br. 6. In support of this assertion,
Appellants contend that "Fatone critically distinguishes his non-concentric,
offset dilators" from concentric dilators, as recited, because Fatone discloses
that concentric dilators "separate the muscle radially and, as such, dilate
tissue on both sides of the stimulating probe. This in tum may impinge on
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Application 14/342,984
neural elements or nerves 9 located outside of the safe zone." Appeal Br. 7
( citing Fatone ,r 25). Appellants also contend that "Fatone further discredits
the use of concentric dilators," because Fatone discloses that
[b ]y using the first and second directional dilators 30, 40, as
compared to concentric sequential dilators as are generally
known to those having skill in the art, the directional sequential
dilation system 10 preferably ensures that the access opening is
created away from the neural elements or nerves 9 of the psoas
muscle 4, thus avoiding any neural elements or nerves 9 that
may, for example, be located on the posterior side of the
stimulating probe 20. Moreover, the directional sequential
dilation system 10 also reduces the amount of tissue damage
when separating the tissue by minimizing the amount of tissue
separation. (Emphasis added).
Appeal Br. 7 ( quoting Fatone ,r 38).
The Examiner responds that Fatone does not teach away from the
claimed invention because "Fatone discusses potential benefits of the device
disclosed in figures 1---6B of Fatone over a concentric dilator, but never
criticizes, discredits, or otherwise discourages concentric dilators." Ans. 9.
Appellants reply that Fatone does more than discuss the benefits of
eccentric dilators by stating problems that could arise by using concentric
dilators. Reply Br. 2. According to Appellants, Fatone's disclosure "is a
clear criticism of concentric dilators to the point of raising concerns about
the safe use of such concentric dilators ... fear of using any device,
particularly one that may impinge on neural elements or nerves with the
consequential problems that could ensue, would manifestly discourage its
use." Id.
Appellants' arguments are not persuasive.
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Application 14/342,984
Although a reference that teaches away is a significant factor to
be considered in determining unobviousness, the nature of the
teaching is highly relevant, and must be weighed in substance.
A known or obvious composition does not become patentable
simply because it has been described as somewhat inferior to
some other product for the same use.
In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Here, concentric dilators
are known, and as in Gurley, do not become patentable simply because they
may impinge on neural elements or nerves. Moreover, a reference "must
[be] considered for all it taught, disclosures that diverged and taught away
from the invention at hand as well as disclosures that pointed towards and
taught the invention at hand." Ashland Oil, Inc. v. Delta Resins &
Refractories, Inc., 776 F.2d 281,296 (Fed. Cir. 1985) (citation omitted). As
the Examiner correctly notes, Fatone teaches additional embodiments in
Figures 7-10 that rely on radially separating the muscle that "operate in the
same manner that appellant has conjectured as being taught away from."
Ans. 11. We agree with the Examiner that "Fatone does not teach away
from use of 'concentric sequential dilators as are generally known to those
having skill in the art.' Instead, it is seen that Fatone provides 'more than
one alternative' to allow dilation and mapping of neural elements or nerves
in a region of interest." Id.; see also Fatone ,r 25. One of ordinary skill in
the surgical arts would use Fatone's mapping information to avoid
impinging the nerve when using a concentric dilator, and thus, would not be
discouraged from using a concentric dilator.
Appellants also argue that Fatone's axes are eccentric in order to
obtain "the desired directional dilation," and that modifying Fatone to make
the dilators "concentric as taught by Smith would manifestly change the
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principle under which Fatone was designed to operate, thereby resulting in a
construction that would be unsatisfactory for its intended purpose." Appeal
Br. 9. According to Appellants, "the proposed modification would create
the very result that Fatone is intending to avoid and has criticized as being
undesirable. This is the antithesis of obviousness." Id.
The Examiner responds that because both Fatone and Smith "are
directed to dilating tissue ... the principles of operation of the device of
Fatone are not contravened by the proposed modifications." Ans. 11. The
Examiner notes, moreover, that because the embodiment of Figures 7-10 of
Fatone separates the muscle radially, "Fatone does not exclude this principle
of operation." Id.
Appellants reply that although "the underlying principle of preparing
a surgical path to a surgical site is accomplished by ... Fatone and Smith ...
the manner in which the surgical path to the surgical site is achieved," is at
issue. Reply Br. 4. According to Appellants, because Fatone was designed
to avoid neural elements or nerves and to reduce tissue damage, which
according to Fatone cannot be achieved by concentric dilators, "the proposed
modification would change the stated principles of operation of Fatone." Id.
We disagree with Appellants that either the principle of operation of
Fatone would be changed or that the proposed modification would render the
device in Fatone unsuitable for its intended use. Appellants incorrectly
characterize the principle of operation of the device in Fatone as requiring
eccentric dilators. See, e.g., Appeal Br. 9; Reply Br. 4. As the Examiner
correctly finds, the embodiment of Figure 7-10 of Fatone would "operate in
the same manner that appellant has conjectured as altering the operation of
the embodiment of figures 1---6B, such as separating the muscle radially."
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Ans. 11. Moreover, we agree with the Examiner that the modified device of
Fatone would remain suitable for its intended purpose, i.e. "dilating tissue."
Id.
We have considered all of Appellants' arguments, but we are not
apprised of Examiner error. Accordingly, we sustain the Examiner's
rejection of claim 19 as unpatentable over Fatone and Smith. Claims 20-22
fall with claim 19.
Re} ections II and III
Claims 23-25 depend directly or indirectly from claim 19. Appellants
do not separately argue claims 23-25. Appeal Br. 5. We sustain the
rejection of claims 23 and 24 as unpatentable over Fatone, Smith, and
Schmitz, and of claim 25 as unpatentable over Fatone, Smith, and Sutton for
the same reasons as discussed in Rejection I.
DECISION
The Examiner's decision to reject claims 19-25 is 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). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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