Ex Parte Perez-Cruet et al

Patent Trial and Appeal Board

Jul 1, 2013

11738211 (P.T.A.B. Jul. 1, 2013)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/738,211 04/20/2007 Miguelangelo J. Perez-Cruet MI4-00009CPA 7053
68779 7590 07/02/2013
MILLER IP GROUP, PLC
MI4 SPINE, LLC
42690 WOODWARD AVE.
SUITE 200
BLOOMFIELD HILLS, MI 48304
EXAMINER
COTRONEO, STEVEN J
ART UNIT PAPER NUMBER
3733
MAIL DATE DELIVERY MODE
07/02/2013 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 MIGUELANGELO J. PEREZ-CRUET,
JOHN R. PEPPER, and JOHN A. MILLER
__________

Appeal 2012-002869
Application 11/738,211
Technology Center 3700
__________

Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to an
interspinous process spacer device. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Appellants identify the Real Party in Interest as MI4Spine, LLC.
(see App. Br. 3).
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Statement of the Case
Background
“This invention relates generally to a spacer device inserted between
the spinous process of adjacent vertebrae and, more particularly, to an
interspinous process spacer device that is percutaneously inserted between
the spinous process of adjacent vertebrae using minimally invasive surgical
procedures” (Spec. 1 ¶ 0002).
The Claims
Claims 1, 3, 6, and 10 are on appeal. Claim 1 is representative and
reads as follows:
1. An interspinous process spacer device comprising:
a body portion including a channel extending
therethrough, wherein the body portion is a cylindrical body
portion;
a plate member attached to the body portion, said
plate member being an annular plate member and being
larger cross-wise than the body portion; and
at least one retaining member mounted to the body
portion, said at least one retaining member being movable
from a stored position where the at least one retaining
member is substantially enclosed within the body portion to
a deployed position where the at least one retaining member
extends from the body portion to provide a space between
the at least one retaining member and the plate member in
which a spinous process can be positioned, wherein the at
least one retaining member is two retaining members
positioned on opposite sides of the body portion, and
wherein the retaining members are tapered so that a narrow
end of the retaining members is closest to the end of the
body portion opposite to the plate member and a wide end of
the retaining members is closest to the plate member.

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The issue
The Examiner rejected claims 1, 3, 6, and 10 under 35 U.S.C. § 103(a)
as obvious over Zucherman ‘938,2 Zucherman ‘948,3 Winslow4 and
Freedland5 (Ans. 4-8).
The Examiner finds that Zucherman ‘938 teaches
an interspinous process spacer device . . . comprising: a
body portion (fig 6A, 501); a plate member (fig 6A, 303)
attached to the body portion, the plate member being larger
cross-wise than the body portion; and at least one retaining
member (paragraph 73 and fig 6A, 512 and 514 “upper
winglet and a lower winglet”) mounted to the body portion,
said at least one retaining member being movable from a
stored position (fig 6A) where the at least one retaining
member is substantially enclosed within the body portion to
a deployed position (fig 6B) where the at least one retaining
member extends from the body portion to provide a space
between the at least one retaining member and the plate
member in which an spinous process can be positioned. The
body is tapered.

(Ans. 5). The Examiner finds that Zucherman ‘948 “discloses a channel
extending through the body (fig 25) to allow for a smaller incision to be
made by guiding the implant over a guide wire” (Ans. 6). The Examiner
finds that “Winslow discloses a cylindrical body” (Ans. 7). The Examiner
finds that “Winslow discloses an annular plate member” (Ans. 8). The
Examiner finds that “Freedland discloses retaining members that taper”
(Ans. 8).

2 Zucherman et al., US 2006/0264938 A1, published Nov. 23, 2006.
3 Zucherman et al., US 5,836,948, issued Nov. 17, 1998.
4 Winslow, C., US 2005/0245937 A1, published Nov. 3, 2005.
5 Freedland, Y., US 5,098,433, issued Mar. 24, 1992.
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The Examiner finds it obvious “to include a channel extending
through the body in view of Zucherman et al. ‘948 in order to allow for a
smaller incision to be made by guiding the implant over a guide wire” (Ans.
7). The Examiner finds it “an obvious matter of design choice to make the
body cylindrical . . . an obvious matter of design choice to make the plate
member annular . . . [and] an obvious matter of design choice to make the
retaining members taper” (Ans. 7-8).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the cited prior art renders claim 1
obvious?
Findings of Fact
1. Zucherman ‘938 teaches “interspinous process implants”
(Zucherman ‘938; 1 ¶ 0012).
2. Figure 6A of Zucherman ‘938 is reproduced below:

“FIG. 6A is a perspective view . . . wherein a first section and a second
section of a distraction guide are deployable to form a second wing”
(Zucherman ‘938; 2 ¶ 0028).
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3. Figure 6B of Zucherman ‘938 is reproduced below:

“FIG. 6B is a perspective view of the implant of FIG. 6A wherein the insert
is positioned within the main body, causing the first section and the second
section of the distraction guide to deploy” (Zucherman ’938; 2 ¶ 0029).
4. Zucherman ‘938 teaches that the “first wing and the second
wing can limit or block movement of the implant along a longitudinal axis of
the implant” (Zucherman ‘938, abstract).
5. Zucherman ‘938 teaches that “the first wing 130 can have other
cross-sectional shapes, such as elliptical, wedge, circular, oval, ovoid,
football, and rectangular with rounded corners and other shapes”
(Zucherman ‘938; 3 ¶ 0054).
6. Zucherman ‘938 teaches that the main body “is shown
including a flange 303 in which is formed notches 305 to receive an
insertion tool” (see figure 6A, Zucherman ‘938; 5 ¶ 0066).
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7. Zucherman ‘938 teaches “one of ordinary skill in the art can
appreciate the myriad different variations of the implant 500 of FIGS. 6A
and 6B. For example, in alternative embodiments the upper winglet 512 and
the lower winglet 514 can have some other shape” (Zucherman ‘938; 6 ¶
0073).
8. Zucherman ‘948 teaches that “an implant is provided for
relieving pain comprising a device positioned between a first spinous
process and a second spinous process” (Zucherman ‘948, col. 1, ll. 37-39).
9. Zucherman ‘948 teaches that the “implant 176 can be inserted
over a guide wire, guide tool or stylet 178. Initially, the guide wire 178 is
positioned through a small incision to the back of the patient to a position
between the adjacent spinous processes” (Zucherman ‘948, col. 7, ll. 41-46).
10. Winslow teaches that “implant 100 comprises a spacer 16 that
maintains the distraction of the spinous processes of adjacent vertebrae, once
the spacer 16 is positioned between the spinous processes 12, 14” (Winslow
1 ¶ 0019).
11. Winslow teaches that the “spacer 316 can be cylindrical, or it
can have other shapes, including but not limited to elliptical or tear-drop
shape in cross-section” (Winslow 3 ¶ 0034).
12. The Examiner finds that “Winslow discloses an annular plate
member (fig 1, 22)” (Ans. 8).

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13. Figure 1 of Winslow is reproduced below:

“FIG. 1 shows a side view of an embodiment of an implant 100 of the
disclosed invention” (Winslow 1 ¶ 0019).
14. Figure 18 of Freedland is reproduced below:

“FIG. 18 is a cross-section of healed bone in which the wing compression
bolt is being removed with the wings rotating and collapsing radially upward
as the bolt is pulled out of the bone” (Freedland, col. 6, ll. 26-29).
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15. Freedland teaches “a surgical implant device for fusing bones
or fixating fractured portions of a single bone in a living body by providing a
compressive and stabilizing force” (Freedland, col. 2, ll. 30-33).
16. Freedland teaches the “remainder of the shape of the wing 40 is
optional. In one embodiment, as illustrated, the upper edge surface 48 of
wing 40 is mostly straight and extends from one end of the lower straight
edge surface 46 to a point” (Freedland, col. 8, ll. 4-8).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
Zucherman ‘938 teaches an interspinous spacer device (FF 1) which
comprises a body portion, a plate member larger cross-wise than the body
portion (FF 6), and mounted retaining members which move from a stored
position enclosed by the spacer device body portion to a deployed position
extended from the body portion (FF 2-3). Zucherman ‘948 teaches inclusion
of a channel through the central body portion (FF 8-9) while Winslow
teaches a cylindrical body (FF 11) and an annular plate member (FF 12-13)
for an interspinous spacer. Freedland teaches a tapered portion of a wing of
an orthopedic fastener (FF 14-16).
Appellants contend that “Zucherman '938 lacks retaining members
that are ‘tapered so that a narrow end of the retaining members is closest to
the end of the body portion opposite to the plate member and a wide end of
the retaining members is closest to the plate member,’ as set forth in claim
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1” (App. Br. 8). Appellants contend that “the Freedland wings 30 and 40 are
not retaining members that move from a stored position within a cylindrical
body portion to an extended position, where the retaining members are
tapered, ‘so that a narrow end of the retaining members is closest to the end
of the body portion opposite to the plate member and a wide end of the
retaining members is closest to the plate member” (App. Br. 9).
The Examiner finds that it “would have been an obvious matter of
design choice to make the retaining members taper, since applicant has not
disclosed that tapering retaining members solves any stated problem or is for
any particular purpose and it appears that the invention would perform
equally well with not tapered retaining members” (Ans. 8).
A “design choice” rationale is appropriate where the Examiner
proposes substituting one prior art element or property for another which
achieves the same result. Cf. In re Gal, 980 F.2d 717, 719 (Fed. Cir.
1992)(“The Board held that Gal had simply made an obvious design choice.
However, the different structures of Gal and Matsumura achieve different
purposes.”). For example, in Kuhle, our reviewing court affirmed a rejection
of a dependent claim where the limitation added by the dependent claim
“solve[d] no stated problem” and “present[ed] no novel or unexpected
result.” In re Kuhle, 526 F.2d 553, 555 (CCPA 1975). There can be no
dispute that Zucherman ‘938 teaches varying shapes for the retaining
members (FF 5).
While we agree with Appellants that the Freedland winged
compression bolt 10 is not an interspinous process spacer device, Freedland
does demonstrate a tapered wing 40 (FF 16) where the tapered wings
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function to prevent movement of the orthopedic device in bone (FF 14-16).
This is the same function performed by the wings of Zucherman ‘938, where
the “first wing and the second wing can limit or block movement of the
implant along a longitudinal axis of the implant” (Zucherman ‘938, abstract;
FF 5).
Thus, we agree with the Examiner that the use of the tapered wings of
Freedman in the place of the wings of Zucherman ‘938 represents a “design
choice” or obvious equivalent since Appellants identify no reason or
problem why tapering of the wings was required nor was any unexpected
result attributed to the use of tapered wings. See KSR, 550 U.S. at 417 (“If a
person of ordinary skill can implement a predictable variation, § 103 likely
bars its patentability.”)
Appellants contend that “the Zucherman '938 implant does not have a
cylindrical body portion with a channel extending therethrough” (App. Br.
7). Appellants contend that “that Winslow also does not teach an implant
having a . . . body portion having a channel extending through it, or with
retaining members on opposite sides of the body portion, where the retaining
members are tapered” (App. Br. 9).
We are not persuaded since this argument does not address the
combination of references. While Appellants are correct that Zucherman
‘938 does not teach a cylindrical body with a channel, Zucherman ‘948
teaches using a spinal implant with a channel for a guidewire in order to
position the implant to the correct location (FF 8-9) “to allow for a smaller
incision to be made in a patient” (Ans. 9). In addition, while Appellants also
correctly note that Zucherman ‘938 does not teach a cylindrical body,
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Winslow teaches a body may have shapes including cylindrical (FF 11). It
is the combination of Zucherman ‘938 with Zucherman ‘948 and Winslow
which renders these alternative structures obvious as known equivalents.
See In re Keller, 642 F.2d 413, 425 (CCPA 1981) (“The test for obviousness
is not whether the features of a secondary reference may be bodily
incorporated into the structure of the primary reference; nor is it that the
claimed invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of the references
would have suggested to those of ordinary skill in the art”.)
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
cited prior art renders claim 1 obvious.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. §
103(a) as obvious over Zucherman ‘938, Zucherman ‘948, Winslow and
Freedland. Pursuant to 37 C.F.R. § 41.37(c)(1), we also affirm the rejection
of claims 3, 6, and 10 as these claims were not argued separately.

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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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