Ex Parte Stewart

Patent Trial and Appeal Board

Jul 13, 2016

13236180 (P.T.A.B. Jul. 13, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/236, 180 09/19/2011 Kenneth Stewart
23646 7590 07115/2016
Barnes & Thornburg LLP (DC)
11 South Meridian Street
Indianapolis, IN 46204
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.
6714-49294 6585
EXAMINER
NELSON, CHRISTINE L
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
07/15/2016 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):
INDOCKET@btlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte KENNETH STEWART
Appeal2014-002272
Application 13/236,180
Technology Center 3700
Before JOHN C. KERINS, JAMES P. CALVE, and
GEORGE R. HOSKINS, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134 from the final rejection of
claims 21, 27-29, and 33--43. 1 Appeal Br. 1-2. Claim 1-20 are cancelled.
Id. at 1. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 In the October 12, 2012, Office Action that was appealed, the Examiner
finally rejected claims 21, 27-29, and 33--43, including a rejection of claims
27, 36, and 37 for obviousness-type double patenting. Final Act. 2-7. The
Examiner withdrew a statutory double patenting rejection of claims 21-26,
28-32, and 43 in the Final Action and then reasserted it as a New Ground of
Rejection in the Answer. Id. at 7; Ans. 5-7. Appellant have appealed the
rejections of claims 21, 27-29, and 33--43 in the Final Action. Appeal Br. 1.
Appeal2014-002272
Application 13/236,180
CLAIMED SUBJECT MATTER
Claims 21, 28, 34, and 38 are independent. Claim 21 is shown below.
21. A bone instrumentation cover capable of being
installed over bone instrumentation which projects from the
bone during bone repair or reconstruction surgical procedure on
an animal comprising:
a hollow cap sized for encapsulating a part of a bone
instrumentation which has been installed in bone, the hollow
cap adapted for placement in the body of the animal and for
encapsulating a part of the bone instrumentation which projects
from the bone, the hollow cap being adapted to provide a
medically safe physical barrier between the part of the bone
instrumentation and the surrounding bone and soft tissue, the
hollow cap being adapted to separate the part of the bone
instrumentation from substantially all of the surrounding soft
tissue so that the hollow cap prevents ingrowth of substantially
all of the surrounding soft tissue through the cap into the bone
instrumentation which projects from the bone, and
the hollow cap having a fastener portion adapted for
securing the cap to the bone instrumentation portion which
projects from the bone.
REJECTIONS
1. Claims 21, 27, 28, 34, and 36-40 are rejected under 35 U.S.C. § 102(e)
as anticipated by Jennings (US 6,810,880 Bl, iss. Nov. 2, 2004).
2. Claims 29 and 33 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Jennings and Ellman (US 4,428,375, iss. Jan. 31, 1984).
3. Claims 41--43 are rejected under 35 U.S.C. § 103(a) as unpatentable over
Jennings and Barron (US 2003/0163161 Al, pub. Aug. 28, 2003).
4. Claim 35 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Jennings and Siebrandt (US 2,435,850, iss. Feb. 10, 1948).
5. Claims 21-32, 36, 37, and 43 are rejected for obviousness-type double
patenting.
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Appeal2014-002272
Application 13/236,180
ANALYSIS
Claims 21, 27, 28, 34, and 36--40 as anticipated by Jennings
The Examiner found that Jennings discloses bone instrumentation
covers including a hollow cap (port 108) and a fastener portion (adhesive
112) that is capable of securing the cap around the bone instrumentation that
projects from the bone and encapsulating the instrumentation. Final Act. 2-
3 (citing Jennings, 6:34--46); Ans. 3 (same). The Examiner also found that
Jennings discloses that the hollow cap can be anchored permanently during
surgery. Final Act. 3 (citing Jennings, 7:23-27); Ans. 3 (same).
Claims 21, 27, 28, 36, 37
Appellant argues that Jennings does not disclose "a fastener portion
adapted for securing the cap to the bone instrumentation" (claim 21) or "a
fastener for snugly securing the cap to the pedicle screw" (claim 28). See
Appeal Br. 6, 9. In particular, Appellant argues that Jennings discloses an
envelope 102 that is bonded adhesively to the exterior skin of a patient, and
the Examiner's finding that this adhesive material 112 can be used to secure
cover 102 to bone instrumentation or a pedicle screw, as claimed, when it is
disclosed in Jennings only for use on skin outside the body, is unsupported
in the record. Id. Appellant also argues that the adhesive would be harmful
if used inside the body of an animal or person, as claimed, because it would
adhere to soft tissue and cause improper healing. Id. at 9.
The Examiner has not explained adequately how Jennings' disclosure
of adhesive 112 that anchors port 108 and envelope 106 to the exterior skin
of a patient (Jennings, 7:24--28) reasonably can be regarded as a disclosure
of an adhesive that can secure port 108 to bone instrumentation or a pedicle
screw installed in a bone in the body of an animal or human, as claimed.
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Appeal2014-002272
Application 13/236,180
The Examiner's finding that "the fastener portion would be fully
capable of securing the cap around [the] bone instrumentation" does not
explain how adhesive 112 would secure port 108 to bone instrumentation or
to a pedicle screw in a bone in an animal or human body. Ans. 3 (emphasis
added). Jennings discloses that adhesive 112 secures envelope 106 and the
associated port 108 to the exterior skin of a patient. Jennings, 7:24--28.
There is no disclosure that adhesive 112 secures port 108 to instrumentation
or anything inside a body of an animal or human. The Examiner's finding in
this regard is speculative.2 Thus, we do not sustain the rejection of claims
21 or 28 or claims 27, 36, and 37, which depend from those claims.
Claim 34
Independent claim 34 recites a bone instrumentation cover comprising
a cap with similar features to the hollow cap in claims 21 and 28 but without
a fastener portion. The Examiner found that Jennings discloses such a cap
for the same reasons as given for claims 21 and 2 8. Final Act. 2-3; Ans. 3.
Appellant argues that there is no disclosure that cover 102 is adapted
for placement in the body of the animal for encapsulating part of the bone
instrumentation that projects from the bone and providing a medically safe
physical barrier as claimed. Appeal Br. 7. Appellant argues that cover 102
is for attachment outside the body rather than placement inside the body to
separate instrumentation installed in bone from surrounding soft tissue. Id.
2 Appellant discloses sutures 16, 26 on hollow cap 10, 20 that secure the cap
or cover in place by attaching the cap or cover to adjacent bone areas, tissue,
or instrumentation. Spec. i-fi-f 17, 21. Appellant discloses toothed edges 1 Oa
on cover 10 that lock onto pedicle screw 12 (id. i-f 17, Fig. 1) and drawstrings
36 that can tighten cover (flexible pouch) 30 around parts of the bone
instruments (id. i122, Fig. 3A).
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Appeal2014-002272
Application 13/236,180
Appellant's arguments are not persuasive because the Examiner found
that port 108 in Figure 5 of Jennings corresponds to the claimed cap. Final
Act. 2; Ans. 3. Appellant's arguments regarding envelope 102, 106 do not
apprise us of error in those findings. Jennings discloses that port 108 can be
used with various implements including implants, batteries, and supplies.
Jennings, 5:63---67. Jennings also teaches that port 108 is inserted through
incision 504 and into the body of a patient and can separate instrumentation
(device 502, 702) from surrounding host tissue. Jennings 7:3---60, Figs. 5-7.
Thus, the Examiner had a sound basis for finding that port 108 is sized and
adapted for placement in the body of an animal and for separating a portion
of bone instrumentation from surrounding tissue, as claimed. Appellant's
arguments do not persuade us that Jennings is not capable of meeting these
limitations. See In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997)
(where the PTO has a reason to believe that a functional limitation is an
inherent characteristic of the prior art, appellant has the burden to show that
the prior art structure does not inherently possess the functional feature).
Thus, we sustain the rejection of claim 34.
Claims 3 8--40
Claim 38 recites the combination of a bone implant and a barrier that
comprises a bone implant and a barrier material. The Examiner found that
Jennings discloses this combination including a bone implant at column 5,
lines 64---66. Final Act. 2-3, Ans. 3.
Appellant argues that Jennings does not mention a bone implant and
therefore Jennings cannot anticipate the combination of a bone implant and a
barrier as recited in claim 34. Appeal Br. 10. We agree.
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Appeal2014-002272
Application 13/236,180
The Examiner has not established by preponderance of evidence that
Jennings discloses "a bone implant." Column 5, lines 64---66 discloses that
the envelope 102 can be used with various surgical implements "such as
implants, implant instruments, implant replacement instruments, batteries,
and supplies." The Examiner has not explained adequately how this passage
discloses a bone implant. We find no express disclosure of a bone implant
in this passage, nor has the Examiner provided sufficient basis to find an
inherent disclosure of a bone implant. See In re Robertson, 169 F.3d 743,
745 (Fed. Cir. 1999) ("Inherency ... may not be established by probabilities
or possibilities. The mere fact that a certain thing may result from a given
set of circumstances is not sufficient."). Thus, we do not sustain the
rejection of claim 38 or its dependent claims 39 and 40.
Claims 29 and 33 as unpatentable over Jennings and Ellman
Claims 29 and 33, which depend from claims 28 and 21 respectively,
recite a cover including sutures that secure the hollow cap to bone or tissue
(claim 29) and pleats on the hollow cap (claim 33). The Examiner relied on
Ellman to teach these features and not to overcome deficiencies of Jennings
discussed above for claims 21 and 28. See Final Act. 3--4; Ans. 4; Appeal
Br. 12, 13. Thus, we do not sustain the rejection of claims 29 and 33.
Claims 41--43 as unpatentable over Jennings and Barron
Claims 41--43 depend respectively from independent claims 38, 34,
and 21 and recite a barrier material/means and hollow cap of hydro gel. The
Examiner relied on Barron to teach this feature and determined that it would
have been obvious to construct the cap of Jennings of hydro gel to better
protect the instrumentation that is implanted by being biocompatible and by
absorbing fluid in the surgical area. Final Act. 4; Ans. 4--5.
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Appeal2014-002272
Application 13/236,180
Appellant argues that Barron discloses the use of hydro gel as a cover
that is applied to a bone anchor before the anchor is implanted to protect the
patient and surgeon from injury during introduction of the device. Appeal
15. Therefore, Appellant argues that Barron does not disclose a cover that
isolates bone implants that are installed in the body and teaches away from
such use. Id. In support of these arguments, Appellant cites the Declaration
of Jeffry Thramann. Id.
Appellant's arguments are not persuasive of error in the Examiner's
finding that Barron teaches a use of hydro gel to cover bone instrumentation
that is implanted into a patient's body or the Examiner's determination that
it would have been obvious to construct the hollow cap of Jennings of such
hydrogel for similar purposes, i.e., to protect the instrumentation that is
implanted and provide biocompatibility. Barron's teaching to use hydrogel
during implantation does not teach away from using hydrogel to cover bone
instrumentation that is implanted. Barron teaches that hydrogel provides a
low profile, close-fitting protective cover that isolates sharp bone anchor tips
and edges to reduce accidents and abrasion of patient tissues and provide a
sterile barrier around a bone anchor during implantation and also to provide
prolonged supplemental antimicrobial protection of the implantation site for
a predetermined time after inserting a bone anchor. Barron i-fi-19-12. These
teachings provide sufficient motivation or reason to form Jennings' cover of
hydrogel as claimed.
Thus, we sustain the rejection of claim 42, which depends from claim
34. We do not sustain the rejection of claims 41 or 43, which depend from
claims 3 8 and 21, respectively, because Barron's teachings do not overcome
the deficiencies of Jennings as to claims 21 or 38, as discussed above.
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Appeal2014-002272
Application 13/236,180
Claim 35 as unpatentable over Jennings and Siebrandt
The Examiner relied on Siebrandt to teach a lower frame 16 with a
box-like aperture shaped for locking the hollow cap to bone instrumentation
as recited in claim 35 and not to overcome any deficiencies of Jennings as to
claim 21 from which claim 35 depends. Final Act. 4--5; Ans. 5. Thus, we
do not sustain the rejection of claim 35.
Claims 21-32, 36, 37, and 43 for obviousness-type double patenting
The Examiner rejected claims 27, 36, and 37 for obviousness-type
double patenting over claims 6, 7, and 12 of U.S. Patent No. 8,025,685 B2
("the '685 patent") because they contain essentially the same subject matter.
Final Act. 5---6. In the Answer, the Examiner rejected claims 21-26, 28-32,
and 43 for obviousness-type double patenting over claims 1-5 and 8-11 of
the '685 patent as a New Ground of Rejection. Ans. 5-7.
Appellant requests that the rejection of claims 27, 36, and 37 in the
Final Action be held in abeyance pending allowance of claims whereupon
Appellant will provide a terminal disclaimer. Appeal Br. 16. Regarding the
New Ground of Double Patenting in the Answer, Appellant argues that the
Examiner's findings that claims 21-26, 28-32, and 43 are "anticipated" by
claims of the '685 patent does not explain why those claims are obvious over
claims of the '685 patent. Reply Br. 1-2. Appellant also argues that the
patented claims include limitations that are not present in the rejected claims
and the Examiner has not explained why the rejected claims would have
been obvious in view of the patented claims. Id. at 1-7. Appellant also
argues that the rejection is confusing because the Examiner previously
withdrew a statutory double patenting rejection of these pending claims in a
previous office action. Id. at 3--4.
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Appeal2014-002272
Application 13/236,180
The Examiner's findings that claims 27, 36, and 37 "contain[]
essentially the same subject matter" (Final Act. 6), and are "anticipated" by,
claims 6, 7, and 12 of the '685 patent (Ans. 7) are insufficient to explain
why those claims should be rejected for non-statutory obviousness-type
double patenting. Thus, we do not sustain the rejection of those claims for
obviousness-type double patenting.
The Examiner's obviousness-type double patenting rejection of claims
21-26, 28-32, and 43 is not supported for the same reasons. We do not
sustain the rejection of those claims for obviousness-type double patenting.
DECISION
We AFFIRM the rejections of claims 34 and 42 and REVERSE the
rejections of claims 21-3 3, 3 5--41, and 4 3.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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