Ex Parte Malinin et al

Patent Trial and Appeal Board

Nov 29, 2016

13057918 (P.T.A.B. Nov. 29, 2016)

United States Patent and Trademark Office
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.
13/057,918 04/15/2011 Theodore Malinin 1.041.11 6286
119489 7590 11/30/2016
ViveY RinmeHioal Tno
EXAMINER
David L. King IWAMAYE, ANDREW MICHAEL
5131 NE County Road 340
High Spring, EL 32643 ART UNIT PAPER NUMBER
3774
MAIL DATE DELIVERY MODE
11/30/2016 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 THEODORE MALININ and TEMPLE H. THOMAS
Appeal 2015-003009
Application 13/057,9181
Technology Center 3700
Before MICHAEL C. ASTORINO, JAMES A. WORTH, and
KENNETH G. SCHOPFER, Administrative Patent Judges.
SCHOPFER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of claims
1—17 and 34—38. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
BACKGROUND
According to Appellants, “[t]he present invention is generally directed
toward composite bone grafts, surgical implant assemblies comprising the
composite bone grafts, and methods of using the same.” Spec. 11.
1 According to Appellants, the real party in interest is the University of
Miami. Appeal Br. 3.
Appeal 2015-003009
Application 13/057,918
CLAIMS
Claims 1—17 and 34—3 82 are on appeal. Claim 1 is the only
independent claim on appeal and recites:
1. A composite graft comprising:
a first bone dowel having the shape of a frustum, said first
bone dowel having a first proximal end and a first distal end and
a first axial bore extending from the first proximal end to the first
distal end, wherein said first distal end has an area greater than
an area of said first proximal end; and
a ligament replacement graft with a first end and a second
end, wherein said first end is attached to said first bone dowel
within said first axial bore such that the first proximal end of said
first bone dowel is closer to the second end of said ligament than
the first distal end,
wherein said first bone dowel comprises:
(a) a bone component comprising particulate bone
of between 75 and 600 microns, powdered bone of 75
microns or smaller in size, or both, and
(b) biocompatible solid comprising a calcium
sulfate hemihydrates, a calcium phosphate product, or
both; and wherein said ligament replacement graft is
structured and configured to produce a constant tension to
retain said first bone dowel at a first site of surgical
installation.
Br. 17.
2 Claims 18—33 are withdrawn. See Br. 21—25.
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Appeal 2015-003009
Application 13/057,918
REJECTIONS
1. The Examiner rejects claims 1, 3—5, 10, 11, 15—17, and 35—38
under 35 U.S.C. § 103(a) as unpatentable over Lambert3 in view of
Boyce.4
2. The Examiner rejects claims 1 and 2 under 35 U.S.C. § 103(a) as
unpatentable over Lambert in view of Meredith.5
3. The Examiner rejects claims 6, 7, and 34 under 35 U.S.C. § 103(a)
as unpatentable over Lambert in view of Boyce and Semple.6
4. The Examiner rejects claims 6, 7, and 34 under 35 U.S.C. § 103(a)
as unpatentable over Lambert in view of Boyce and Mansat.7
5. The Examiner rejects claims 8, 9, 12, and 13 under 35 U.S.C.
§ 103(a) as unpatentable over Lambert in view of Boyce and
Enzerink.8
6. The Examiner rejects claims 12—14 under 35 U.S.C. § 103(a) as
unpatentable over Lambert in view of Boyce and Bianchi.9
DISCUSSION
With respect to claim 1, the Examiner finds that Lambert teaches a
composite graft including a first bone dowel and a ligament replacement
graft as claimed except that Lambert does not teach a bone dowel “made
from the claimed composition.” Final Act. 4—5 (citing Lambert Fig. 24).
3 Lambert, M.D., US 2008/0027443 Al, pub. Jan. 31, 2008.
4 Boyce et al., US 2003/0039676 Al, pub. Feb. 27, 2003.
5 Meredith, US 2003/0036800 Al, pub. Feb. 20, 2003.
6 Semple et al., US 3,973,277, iss. Aug. 10, 1976.
7 Mansat et al., US 5,108,431, iss. Apr. 28, 1992.
8 Enzerink et al., US 2002/0165611 Al, pub. Nov. 7, 2002.
9 Bianchi et al., US 2006/0212036 Al, pub. Sept. 21, 2006.
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Appeal 2015-003009
Application 13/057,918
The Examiner finds that both Boyce and Meredith disclose bone graft
material as claimed. Id. at 5 (citing Boyce H 71, 84, 87), 8 (citing Meredith
59, 71, 72, 79; claim 48). The Examiner concludes that it would have
been obvious to modify Lambert’s bone dowel to include the claimed
composition, as taught by Boyce or Meredith, “in order to employ an
alternative bone composition that promotes bone tissue formation.” Id.
(citing Boyce H 8—10; Meredith 142). The Examiner also finds that
Lambert modified with either Boyce or Meredith would be structurally
identical to the claimed device and would be inherently capable of producing
a constant tension to retain the first bone dowel at the site of surgical
installation, as claimed. Id. at 6, 8. Finally, the Examiner also finds that
“the claims do not preclude the use of cements or glues as taught in Lambert
to help retain the dowel in place. In [either proposed] combination, a
mixture of cement/glue and tensile forces naturally assist in retaining the
bone dowel within the bone.” Id. at 6, 9.
Appellants address both rejections of claim 1 together and raise
several arguments: 1) the Examiner conclusion that the combination is
inherently structured to produce constant tension to hold the bone dowel in
place is conclusory and incorrect because Lambert teaches using bone
cement for anchoring to the bone; 2) the invention is not a predictable result
from the proposed combination; 3) the examples in the Specification show
the invention overcomes a long-felt but unsolved need; and 4) that the prior
art teaches away from the claimed invention. See Br. 9-16. As discussed
below, we are not persuaded of reversible error by Appellants’ arguments.
Regarding Appellants’ first argument, we find that the proposed
combination would at least be capable of functioning in the manner claimed,
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Appeal 2015-003009
Application 13/057,918
i.e. providing tension to retain a bone dowel at a surgical site. Lambert
discloses:
Disclosed herein is a method of anchoring a graft to a bone
portion. The method comprises forming a first bore in a first
bone portion, the first bore comprising a major opening, a minor
opening, and a tapered sidewall disposed therebetween;
disposing a first portion of the graft in the first bore; disposing a
first portion of a bone cement precursor in the first bore, such
that the first portion of the graft is substantially completely
embedded in the first portion of bone cement precursor, and such
that the first portion of bone cement precursor substantially
conforms to the tapered sidewall of the first bore; and allowing
the first portion of the bone cement precursor to set to form a first
bone cement anchor disposed in the first bore, wherein the first
portion of the graft is anchored in the first bone cement anchor
and a second portion of the graft extends from the minor opening.
The method also comprises disposing the graft in the first
bore with a selected amount of tension in the direction of the
minor opening. The sidewall of the first bore comprises an angle
of greater than or equal to about 20 degrees to about 45 degrees.
In some embodiments, the bone cement comprises
hydroxylapatite.
Lambert H 11, 12; see also id. at Figs. 19-23; 172. Thus, Lambert not only
discloses disposing a graft in two opposing bores and anchoring the graft
with bone cement, but Lambert also discloses disposing the graft with an
amount of tension in the direction of the minor opening of the bore. We find
that placing the graft with some amount of tension would necessarily impart
some retaining force on the bone cement filled bores. Thus, we agree with
the Examiner’s finding that Lambert, and the proposed combinations with
Lambert, are inherently capable of producing a constant tension to retain a
bone dowel at a surgical site, as claimed.
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Appeal 2015-003009
Application 13/057,918
Regarding Appellants’ remaining arguments, they are all premised on
the fact that Lambert uses bone cement to anchor the graft in place while
Appellants’ invention is allegedly directed at a system that avoids permanent
fixation means, such as screws, pins, nails, cement, etc. Br. 13—14.
However, we agree with the Examiner’s response to each of these
arguments, i.e. each argument is unpersuasive at least because the claims as
currently worded do not preclude the use of other fixation means such as the
cement used by Lambert. See Ans. 3—8.
Appellants also attempt to overcome the rejection by expressly
disavowing “the use of setting bone cement as a requirement for
anchoring the composite graft.” Br. 11. We are not persuaded that the
rejection should not be sustained based on this attempted disavowal of claim
scope. In this matter, we are guided by our reviewing court which has stated
“during patent prosecution when claims can be amended, ambiguities should
be recognized, scope and breadth of language explored, and clarification
imposed. . . . [Tjhis way . . . uncertainties of claim scope [can] be removed,
as much as possible, during the administrative process.” In re Zletz, 893
F.2d 319, 321—22 (Fed. Cir. 1989) (emphasis added). If Appellants wish to
affirmatively limit the scope of their claims, the appropriate procedure for
doing so while prosecution is open is through an amendment to the claims,
and we decline to limit the claims based on Appellants’ Brief. We also note
that the Examiner has identified an inconsistency between Appellants’
statement of disavowal and the description of the bone dowels in the
Specification, which creates ambiguity regarding the extent of claim scope
Appellants are attempting to disavow. See Ans. 7—8 (citing Spec. ]Hf 52, 69,
and 73).
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Appeal 2015-003009
Application 13/057,918
Based on the foregoing, we are not persuaded of reversible error, and
we sustain the rejections of claim 1 over Lambert in view of Boyce or
Meredith. Appellants do not raise any separate arguments regarding any
other rejections or any of the dependent claims, and thus, we sustain the
rejections of dependent claims 2—17 and 34—38 for the same reasons.
CONCLUSION
For the reasons set forth above, we AFFIRM the rejections of claims
1—17 and 34—38.
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
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