Ex Parte Foley et al

Patent Trial and Appeal Board

Oct 14, 2014

11416892 (P.T.A.B. Oct. 14, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte KEVIN T. FOLEY and ROY LIM
__________

Appeal 2012-005177
Application 11/416,892
Technology Center 3700
__________

Before LORA M. GREEN, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

PER CURIAM

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1, 2, 5–10, 12–14, 19, 20, 23, and 24.2 We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 The Real Party in Interest is Warsaw Orthopedic, Inc. (App. Br. 2).
2 Claim 11 is also pending (App. Br. 2), but the Examiner has withdrawn the
rejection of that claim (Ans. 4).
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Application 11/416,892

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STATEMENT OF THE CASE
The Specification discloses “methods and devices to increase the disc
height between adjacent vertebral members” (Spec. 1, ¶ 0004). Claim 1 is
representative of the claims on appeal and reads as follows:
1. A method of spacing vertebral members within a patient
comprising the steps of:
inserting a spacer through a cannula and into a disc space between the
vertebral members while the spacer is positioned at a first end of a delivery
device and a deploying mechanism is positioned at a second end of the
delivery device, the spacer is contained within a sheath and an end of the
sheath is positioned on an exterior of the patient and the deploying
mechanism is positioned outside of the sheath;
expanding a height of the spacer with the deploying mechanism to
increase a distance between the vertebral members to form a disc height;
inserting a material in a first form into the disc space;
changing the material to a second form that is more viscous than the
first form; and
after the material changes to the second form that maintains the disc
height, reducing the height of the spacer and removing the spacer from the
disc space.

Issue
The Examiner has rejected claims 1, 2, 5–10, 12–14, 19, 20, 23, and
24 under 35 U.S.C. § 103(a) as obvious over the combination of Felt,3
Cantu,4 Slater,5 and Manzi6 (Ans. 5–8).7 We focus our initial analysis on
independent claim 1.

3 Felt et al., US 6,248,131 B1, Jun. 19, 2001.
4 Cantu, US 2006/0235423 A1, Oct. 19, 2006.
5 Slater et al., US 5,347,995, Sept. 20, 1994.
6 Manzi et al., US 2005/0182414 A1, Aug. 18, 2005.
Appeal 2012-005177
Application 11/416,892

3
The issue presented is: Has the Examiner established by a
preponderance of the evidence that the combination of Felt, Cantu, Slater,
and Manzi would have made obvious a method of spacing vertebral
members within a patient comprising the step of “inserting a spacer through
a cannula and into a disc space between the vertebral members . . . [wherein]
the spacer is contained within a sheath and an end of the sheath is positioned
on an exterior of the patient,” as required by claim 1?
Findings of Fact
FF1. The Examiner finds that Felt discloses a “method of spacing
vertebral members by inserting an inflatable device in a disc space between
adjacent vertebrae and filling the device with a gas to inflate . . . the device
and distract the disc space” (Ans. 5 (citing Felt at col. 5, ll. 48–50)).
FF2. The Examiner finds that once the Felt device is inflated, “a first
biomaterial is delivered to [a] perimeter of the annular space and cured” (id.
(citing Felt at col. 6, ll. 23–26 and 30–32)).
FF3. The Examiner finds that Felt “fails to disclose the use of a
spacer that is contained within a sheath with an end of the sheath positioned
outside of the patient to expand the height of the disc space” (id. at 5–6).
FF4. The Examiner finds that Cantu discloses “a spacer for
maintaining disc height during [a] disc or nucleus procedure” (id. at 6 (citing
Cantu at ¶ 0025)).

7 The Examiner’s statement of the rejection included claims 15, 17, 18, and
21 (Ans. 5), but Appellants indicate that these claims have been canceled
(App. Br. 2).
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Application 11/416,892

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FF5. The Examiner finds that Cantu’s “device can be fully wrapped
in a sheath 146 to prevent unwanted biological material from entering into
the spacer device” (id. (citing Cantu at ¶ 0039)).
FF6. The Examiner finds that Cantu’s mechanical spacer “provides a
more controlled distraction means as compared to [an] inflatable device”
(id.).
FF7. Cantu discloses medical devices “that can be used for a variety
of medical procedures such as a medical procedure to alter the height of a
vertebral body” (Cantu 1, ¶ 0001).
FF8. Figure 2 of Cantu is shown below:

Figure 2 shows “an exploded view of a medical device” (id. at 1, ¶ 0007).
FF9. Cantu discloses that the “[m]edical device 120 includes a link
assembly 122 . . . and an actuating member 124 configured to couple to link
assembly 122” (id. at 3, ¶ 0033).
FF10. Cantu discloses that, “[i]n use, the link assembly 122 in a
collapsed configuration, actuating member 124, first member 126 and
second member 128 are passed through the cannula 138 to a selected
location within a body of a patient, such as a vertebra” (id. at 4, ¶ 0043).

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Appeal 2012-005177
Application 11/416,892

6
that is inserted into the body is sterile” (id. (citing Slater at col. 1, ll. 32–
34)).
FF16. Slater discloses that a “laryngoscope is a device that is used by
a physician to examine a patient’s throat . . . [and] consists generally of a
blade movably attached to a cylindrically shaped handle” (Slater, col. 1, ll.
11–14).
FF17. Slater discloses that it is “important that a laryngoscope blade
remain sterile in order to prevent the transmission of serious diseases . . . .
This fact led to the development of disposable laryngoscope blade covers”
(id. at col. 1, ll. 21–26).
FF18. Slater discloses “a disposable laryngoscope blade cover that
includes a flexible sleeve and a resilient slide band for use in conjunction
with a laryngoscope having a blade and a handle” (id. at col. 1, ll. 37–39).
FF19. Slater discloses that the “sleeve has an open end and a closed
end. The open end is received by the blade and the handle. The sleeve
covers the blade and at least a portion of the handle” (id. at col. 1, ll. 40–43).
FF20. The Examiner concludes that, in view of Cantu and Slater, it
would have been obvious to one skilled in the art to perform Felt’s method
with the use of a spacer that is contained within a sheath . . . so
that the sheath extends to the exterior of a patient . . . and the
deploying mechanism is positioned outside of the sheath . . . in
order to provide a controlled means of distraction . . . while
providing a cheap and easy to use device to maintain a sterile
environment.

(Id. at 6–7.)
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FF21. The Examiner relies on Manzi and Manzi’s incorporation by
reference of U.S. Patent No. 6,595,998 to meet dependent claim limitations
(id. at 7–8 and 9).
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).
If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability. For the same
reason, if a technique has been used to improve one device, and
a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond his
or her skill.

Id. at 417. In determining whether obviousness is established by combining
the teachings of the prior art, “the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425 (CCPA 1981).
Analysis
Appellants argue that the cited references do not disclose or suggest,
inserting “a sheathed object through a cannula and into a patient with the end
of the sheath remaining on the exterior of the patient” (App. Br. 6).
Appellants argue that although Cantu discloses that a “spacer and wrap may
be inserted into the patient through a cannula . . . [t]he wrap is completely
positioned in the patient and a distal end is not positioned on an exterior of
the patient” (id. at 7). Appellants argue that although “Slater discloses a
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Application 11/416,892

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laryngoscope that includes a blade that is inserted into the throat, and a
handle that is grasped by the doctor . . . [wherein a] cover extends over the
blade and along a section of the handle,” the laryngoscope is not used with a
cannula (id.). Appellants argue that Slater’s laryngoscope “includes an
enlarged size that would not appear to be applicable for insertion through a
cannula” (id.). Appellants argue that, upon reviewing the cited references,
one of ordinary skill in the art “would not recognize that a device in a sheath
can be inserted into a patient through a cannula with a portion of the sheath
remaining on an exterior of a patient” (id.).
Appellants’ arguments are not persuasive. Cantu discloses medical
devices that can be used to alter the height of a vertebral body, wherein the
medical device includes a wrap or protective covering that encases the
mechanically operative part of the device that is placed within the body to
prevent to prevent biological material from entering the device during use
(FFs 7, 11, and 12). Slater discloses a medical device, i.e. a laryngoscope,
which includes a flexible sleeve cover that covers the blade and at least a
portion of the handle for the purpose of maintaining sterility of the device
(FFs 17–19). “[T]he test is what the combined teachings of the references
would have suggested to those of ordinary skill in the art.” In re Keller, 642
F.2d 413, 425 (CCPA 1981). We, thus, agree with the Examiner that it
would have been obvious to the ordinary artisan that, in view of Slater,
Cantu’s device wrap could be modified to be a protective sleeve that extends
outside the body to thereby serve both purposes of protecting the device and
providing sterility of the device, and also to facilitate the ease of application
of a protective covering to the Cantu device.
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Application 11/416,892

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Appellants’ argument that, in view of the references, one of ordinary
skill in the art would not recognize that a sheathed device could be inserted
into a patient through a cannula, with a sheath portion remaining exterior to
the patient, is also not persuasive. Cantu discloses that a sheathed device is
deployed through a cannula (FFs 10 and 12) and using a sheath that extends
outside the body and outside the cannula would not only provide device
protection and sterility, as discussed above, but would also ensure that the
sheath could be removed from the cannula along with the device.
Thus, we affirm the rejection of claim 1 as being obvious over the
combination of Felt, Cantu, Slater, and Manzi. Claims 2 and 5–9 have not
been argued separately from claim 1, and, therefore, fall with that claim.
37 C.F.R. § 41.37(c)(1)(vii).
Appellants also argue the rejection of independent claim 10. Claim 10
is directed to a method of spacing vertebral members comprising, among
other steps, the steps of “extending the sheath over the spacer and over a
limited portion of an elongated member attached to the spacer; inserting the
spacer and the sheath through a cannula and into a disc space between the
vertebral members with the opening of the sheath positioned on the exterior
of the patient” (emphasis added).8
Appellants argue that “there is no disclosure or suggestion in any of
the references, either alone or in combination, to insert a sheathed object
through a cannula and into a patient with the end of the sheath remaining on
the exterior of the patient” (App. Br. 9). Appellants argue that, “[f]or at least

8 The full text of claim 10 can be found in the Claims Appendix to the
Appeal Brief (App. Br. 12).
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this reason, independent claim 10 is not made obvious” over the
combination of the cited references (id.).
Appellants’ argument is not persuasive for the reasons discussed
above. Thus, we affirm the rejection of claim 10 as being obvious over the
combination of Felt, Cantu, Slater, and Manzi. Claims 12–14 have not been
argued separately from claim 10, and therefore, fall with that claim.
37 C.F.R. § 41.37(c)(1)(vii).
Appellants also argue the rejection of independent claim 19. Claim 19
is directed to a method of spacing vertebral members comprising, among
others, “the steps of: inserting a spacer and a portion of an insertion member
into a sheath; inserting the spacer within the sheath into a disc space between
the vertebral members while a portion of the sheath is positioned on an
exterior of the patient” (emphasis added).9
Appellants argue that “there is no disclosure or suggestion in any of
the references, either alone or in combination, to insert a sheathed object
through a cannula and into a patient with the end of the sheath remaining on
the exterior of the patient” (App. Br. 9). Appellants argue that, “[f]or at least
this reason, independent claim 19 is not made obvious” over the
combination of the cited references (id.).
Appellants’ argument is not persuasive for the reasons discussed
above. Thus, we affirm the rejection of claim 19 as being obvious over the
combination of Felt, Cantu, Slater, and Manzi. Claims 20, 23, and 24 have

9 The full text of claim 19 can be found in the Claims Appendix to the
Appeal Brief (App. Br. 13).
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not been argued separately from claim 19, and therefore, fall with that claim.
37 C.F.R. § 41.37(c)(1)(vii).
Conclusion of Law
The preponderance of the evidence supports the Examiner’s
conclusion that the combination of Felt, Cantu, Slater, and Manzi would
have made obvious a method of spacing vertebral members within a patient
comprising the step of “inserting a spacer through a cannula and into a disc
space between the vertebral members . . . [wherein] the spacer is contained
within a sheath and an end of the sheath is positioned on an exterior of the
patient,” as required by claim 1.
SUMMARY
We affirm the rejection of claims 1, 2, 5–10, 12–14, 19, 20, 23, and 24
under 35 U.S.C. § 103(a).
TIME PERIOD FOR 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).

AFFIRMED

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