Ex Parte Simonson

Patent Trial and Appeal Board

Nov 30, 2012

10899707 (P.T.A.B. Nov. 30, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte ROBERT E. SIMONSON
________________

Appeal 2012-010358
Application 10/899,707
Technology Center 3700
________________

Before STEVEN D.A. McCARTHY, BRETT C. MARTIN and
ANNETTE R. REIMERS, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
The Appellant1 appeals under 35 U.S.C. § 134 from the Examiner’s 1
decision finally rejecting claims 1-6, 8-13 and 22-41. The Examiner rejects 2
claims 1-5, 8, 9, 11, 13, 22, 26, 32-37, 39 and 40 under 35 U.S.C. § 103(a) 3
as being unpatentable over Foley (US 5,792,044, issued Aug. 11, 1998) and 4
Sasso (US 6,287,313 B1, issued Sep. 11, 2001); claims 10 and 12 under5

1 The Appellant identifies the real party in interest as DePuy Spine, Inc.
of Raynham, Massachusetts, a Johnson & Johnson company.
Appeal No. 2012-010358
Application No. 10/899,707

2
§ 103(a) as being unpatentable over Foley, Sasso and Sugarbaker (US 1
5,342,384, issued Aug. 30, 1994); and claims 6, 23-25, 27-31, 38 and 41 2
under § 103(a) as being unpatentable over Foley, Sasso and Bhatnagar (US 3
6,395,007 B1, issued May 28, 2002).2 Claims 7 and 14-21 are cancelled. 4
We have jurisdiction under 35 U.S.C. § 6(b)(1). 5
We AFFIRM. 6
The application underlying this appeal was before the Board in 7
Appeal 2009-010060. The Board affirmed the rejection of all claims then on 8
appeal in a Final Decision dated December 2, 2010. Since that Final 9
Decision, the Appellant has amended independent Claim 1 to read as 10
follows: 11
1. A method of creating a working 12
channel from a skin incision to proximate a 13
vertebra, comprising: 14
making a skin incision in a patient, 15
inserting a distal end of a non cannulated 16
dilator into the skin incision, 17
advancing the distal end of the dilator into 18
proximity to a vertebra, the dilator extending from 19
proximate the vertebra to external to the skin 20
incision, 21
inserting a plurality of cannulated dilators 22
over the non cannulated dilator, 23
inserting a cannula over the plurality of 24
cannulated dilators, and 25

2 On page 5 of the Final Office Action mailed December 14, 2011, the
Examiner rejected claims 1-6, 8-13, 27-35 and 37-41 under the first
paragraph of 35 U.S.C. § 112 for failure to comply with the written
description requirement. The Examiner withdrew this ground of rejection in
the Answer. (See Ans. 9).
Appeal No. 2012-010358
Application No. 10/899,707

3
removing the non cannulated dilator and the 1
plurality of cannulated dilators, a bore of the 2
cannula defining a working channel from the skin 3
incision to proximate the vertebra, 4
wherein the working channel is the only 5
working channel in the patient proximate the 6
vertebra such that, after the removal of the non 7
cannulated dilator and the plurality of cannulated 8
dilators, all instruments advanced into proximity of 9
the vertebra are inserted into the patient through 10
the working channel. 11
12
ISSUES 13
The Appellant argues claims 1-5, 8, 9, 11, 13 and 39 as a group for 14
purposes of the rejection of those claims as being unpatentable over Foley 15
and Sasso. (See App. Br. 7-12; Reply Br. 3-6). Claim 1 is representative of 16
the group. Since the Appellant does not present any arguments regarding the 17
rejection of claims 22, 26, 36, 37 and 40 separate from the arguments 18
directed against the rejection of claim 1 (see App. Br. 12), claim 1 also is 19
representative of the latter claims for purposes of the rejection as being 20
unpatentable over Foley and Sasso. 21
The Appellant argues the patentability of claim 6, 23-25, 27-31, 38 22
and 41 solely on the basis that Bhatnagar fails to remedy perceived 23
deficiencies in the combined teachings of Foley and Sasso addressed in 24
connection with the rejection of claim 1. (App. Br. 12-13). The Appellant 25
similarly argues the patentability of claims 10 and 12 solely on the basis that 26
Sugarbaker fails to remedy perceived deficiencies in the combined teachings 27
of Foley and Sasso addressed in connection with the rejection of claim 1. 28
(See App. Br. 13). Therefore, the Appellant’s arguments regarding these 29
Appeal No. 2012-010358
Application No. 10/899,707

4
claims raise no issue separate from the issues raised in connection to the 1
rejection of claim 1. 2
Only issues and findings of fact contested by the Appellant have been 3
considered. See Ex parte Frye, 94 USPQ2d 1072, 1075-76 (BPAI 2010). 4
This appeal turns on a single issue: 5
Do the evidence and technical reasoning underlying the 6
rejection of representative claim 1 adequately support the 7
conclusion that one of ordinary skill in the art would have had 8
reason to combine the teachings of Foley and Sasso so as to 9
combine steps of advancing the distal end of a non cannulated 10
dilator into proximity to a vertebra and inserting a plurality of 11
cannulated dilators over the non cannulated dilator? (See Br. 7-12
12; Reply Br. 3-6). 13
14
FINDINGS OF FACT 15
The record supports the following findings of fact (“FF”) by a 16
preponderance of the evidence. 17
1. We adopt and incorporate by reference the Examiner’s findings 18
at page 3, line 12 of the Answer (starting with “Foley discloses . . .”) through 19
page 4, line 16 of the Answer (ending with “. . . the first tool inserted 20
through a skin incision for creating a working channel.”). 21
2. We adopt and incorporate by reference the Examiner’s findings 22
at page 10, line 15 of the Answer (starting with “Sasso’s disclosure of a 23
cannula . . .”) through page 11, line 4 of the Answer (ending with “. . . the 24
trocar of Sasso functions equivalently to the guide wire of Foley.”). 25
Appeal No. 2012-010358
Application No. 10/899,707

5
3. Foley describes spinal surgical procedures. (Foley, col. 10, ll. 1
12-14). One such procedure includes steps in which a series of tissue 2
dilators are advanced one over the other along a guidewire extending from 3
the skin into the laminae M of a vertebral body V. (Foley, col. 10, ll. 35-37 4
and figs. 10a-10d; see also id., col. 10, ll. 19-21). Another such procedure 5
includes the steps of advancing the dilators through an incision in the skin 6
without the aid of a guidewire, followed by blunt dissection of the 7
underlying tissues. (Foley, col. 10, ll. 37-40). In either procedure, these 8
steps are followed by a step of advancing a working channel cannula 20 over 9
the largest dilator and then removing the dilators. (Foley, col. 10, ll. 51-54). 10
4. Sasso describes a screw delivery system kit for use in 11
minimally invasive surgery. The kit includes an outer cannula, a trocar, a 12
guide and a bone drill bit. (Sasso, col. 2, ll. 13-16). 13
5. Sasso teaches that: 14
In the generalized method of use, the soft tissue 15
penetrator or introducer in the form of the outer 16
cannula 100 with the trocar 120 having a bullet-17
shaped head 130 is introduced through an incision 18
50 in the skin on the back and directed toward the 19
surgical site (in FIG. 11 the surgical site is across 20
lumbar vertebra) viewed through incision 55. The 21
tip 110 of the outer cannula 100 is then seated on 22
the portion of the bone or vertebra at the 23
appropriate angle for the introduction of the screw 24
for fixation. The bullet-shaped head 130, and 25
indeed the entire trocar 120, are then removed 26
from the outer cannula 100. 27
(Sasso, col. 8, ll. 6-16). 28
Appeal No. 2012-010358
Application No. 10/899,707

6
ANALYSIS 1
Sasso describes inserting an outer cannula 100 and a trocar 120 as a 2
unit through an incision in a patient’s skin to form a passage extending from 3
the skin to a vertebral body. (FF 1 and 5). As the name implies, Sasso’s 4
outer cannula 100 is cannulated. On the other hand, Sasso’s introducer, that 5
is, the combination in which Sasso’s trocar 120 substantially fills the 6
cannula within the outer cannula 100 and the two advance into the body as a 7
unit, acts as a non cannulated dilator. Foley describes sequentially 8
advancing a plurality of cannulated dilators over one another to enlarge a 9
passage defined by a guidewire or a by a dilator previously inserted over a 10
guidewire. (FF 1 and 3). The Examiner correctly concludes that it would 11
have been obvious 12
to first insert a non-cannulated dilator as taught by 13
Sasso into the skin incision of the Foley method 14
instead of first inserting a guide wire through the 15
skin incision, as this modification merely involves 16
the substitution of functionally equivalent devices 17
for making initial paths through skin incisions to 18
obtain the predictable result of establishing a 19
working channel through tissue near a vertebra. 20
(Ans. 4). 21
The Examiner correctly finds that Sasso’s introducer, that is, the 22
combination of Sasso’s outer cannula 100 and trocar 120, would have been 23
the functional equivalent of the guidewire described by Foley. The 24
differences in structure or function between Foley’s guidewire and Sasso’s 25
introducer are insubstantial. Each consists of an elongated body inserted 26
through a skin incision and advanced into a patient toward a vertebral body. 27
(See FF 2, 3 and 5). One might expect a guidewire to be thinner than the 28
introducer described by Sasso. This difference is insubstantial, however. 29
Appeal No. 2012-010358
Application No. 10/899,707

7
Since Foley teaches initiating a passage to a vertebral body using either a 1
guidewire or a cannulated dilator (FF 3), one cannot conclude that any 2
difference in thickness between a guidewire and a cannulated dilator 3
substantially affects the way in which the guidewire or the cannulated dilator 4
functions. 5
“[W]hen a patent claims a structure already known in the prior art that 6
is altered by the mere substitution of one element for another known in the 7
field, the combination must do more than yield a predictable result.” KSR 8
Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 416 (2007). The Appellant does not 9
appear to argue that one of ordinary skill in the art familiar with the 10
teachings of Foley and Sasso would be unable to implement the substitution 11
proposed by the Examiner. Neither does the Appellant offer a persuasive 12
reason why the Examiner erred in finding that the result of the substitution 13
would have been predictable. Therefore, the Examiner correctly concluded 14
that it would have been obvious to initiate a passage by advancing the distal 15
end of a non cannulated dilator into proximity to a vertebra and to then 16
enlarge the passage by inserting a plurality of cannulated dilators over the 17
non cannulated dilator. 18
The Appellant correctly points out that Sasso does not teach the use of 19
additional non cannulated dilators to enlarge the passage opened up using 20
the outer cannula 100 and the trocar 120. (See, e.g., App. Br. 8). The 21
Appellant then contends that “the suggested combination of Foley and Sasso 22
does not render claim 1 obvious because the proposed modification would 23
not only make Foley unsatisfactory for its intended purpose, but it would 24
also change Foley’s principle of operation.” (App. Br. 8-9). While these 25
principles provide guidance in determining whether the subject matter of a 26
Appeal No. 2012-010358
Application No. 10/899,707

8
claim would have been obvious, the ultimate question remains “whether 1
there was an apparent reason to combine the known elements in the fashion 2
claimed.” KSR Int’l at 418. In performing this analysis, “we do not ignore 3
the modifications that one skilled in the art would make to a device 4
borrowed from the prior art.” In Re ICON Health & Fitness, Inc., 496 F.3d 5
1371, 1382 (Fed. Cir. 2007)(citing Optivus Tech., Inc. v. Ion Beam 6
Applications, S.A., 469 F.3d 978, 989-90 (Fed. Cir. 2006)). 7
Foley describes advancing a plurality of cannulated dilators over the 8
combination of a previously-inserted cannulated dilator and a guidewire to 9
enlarge a passage to a vertebral body. (FF 1 and 3). One familiar with this 10
teaching would have had reason to advance a plurality of cannulated dilators 11
over the combination of a previously-inserted cannulated dilator and a trocar 12
to enlarge a passage to a vertebral body. While this is not the particular 13
method of operation described by Sasso, the proposed combination can be 14
seen as the application of a known improvement taught by Foley to a similar 15
technique described by Sasso. See KSR Int’l at 417 (“[I]f a technique has 16
been used to improve one device, and a person of ordinary skill in the art 17
would recognize that it would improve similar devices in the same way, 18
using the technique is obvious unless its application is beyond his or her 19
skill.”). 20
We sustain the rejection of claims 1-5, 8, 9, 11, 13, 22, 26, 32-37, 39 21
and 40 under § 103(a) as being unpatentable over Foley and Sasso. Since 22
the Appellant has not identified any deficiency in the teachings of Foley and 23
Sasso as applied to claim 1, we sustain the rejection of claims 10 and 12 24
under § 103(a) as being unpatentable over Foley, Sasso and Sugarbaker; and 25
Appeal No. 2012-010358
Application No. 10/899,707

9
the rejection of claims 6, 23-25, 27-31, 38 and 41 under § 103(a) as being 1
unpatentable over Foley, Sasso and Bhatnagar. 2
DECISION 3
We AFFIRM the Examiner’s decision rejecting claims 1-6, 8-13 and 4
22-41. 5
No time period for taking any subsequent action in connection with 6
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). 7
8
AFFIRMED 9
10
11
12
Klh 13