University of Kansas

Patent Trials and Appeals Board

Nov 18, 2020

2020001890 (P.T.A.B. Nov. 18, 2020)

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.
13/741,263 01/14/2013 Terence Edward McIff 13KU039M-02 1086
147202 7590 11/18/2020
Ray Quinney & Nebeker-KU
Paul N. Taylor
36 South State Street
Suite 1400
Salt Lake City, UT 84111
EXAMINER
KU, SI MING
ART UNIT PAPER NUMBER
3775
NOTIFICATION DATE DELIVERY MODE
11/18/2020 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):
patent@rqn.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte TERENCE EDWARD McIFF and
EDWARD BRUCE TOBY
__________

Appeal 2020-001890
Application 13/741,263
Technology Center 3700
__________

Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and
ANNETTE R. REIMERS, Administrative Patent Judges.

GREENHUT, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–5, 8–12, 14, 21, 24–27, 29–32, 34–
38, and 44–48. See Non-Final Act. 1. Claims 6, 7, 13, 15–20, 22, 23, 28, 33,
and 39–43 have been canceled. Id. at 2. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as The
University of Kansas. Appeal Br. 3.
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Application 13/741,263

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STATEMENT OF THE CASE
The claims are directed to a device for securing adjacent bones and for
preventing the bones from rotating relative to each other. Claim 1,
reproduced below, is illustrative of the claimed subject matter:
1. A compact anti-rotation device for securing adjacent
bones, including bone portions, and preventing or impeding such
bones from relative rotation thereof, to facilitate healing of the
bones or tissue or ligaments connected thereto, the device
comprising:
a torsion bar having a first end and a second end and a
longitudinal axis extending through the torsion bar and between
the first end and the second end both prior to insertion into a bone
and after insertion into a bone, such that the longitudinal axis of
the torsion bar remains straight prior to insertion into a bone and
after insertion into a bone;
a first anchoring member coupled to or integrated with the
first end of the torsion bar, the first anchoring member having a
first prong directly connected to the torsion bar at a proximal end
of the first prong and along the longitudinal axis of the torsion
bar at the first end of the torsion bar, the first anchoring member
having a second prong directly connected to the torsion bar at a
proximal end of the second prong and along the longitudinal axis
of the torsion bar, the first prong and the second prong having a
first length that is the same, the first prong and the second prong
lying in a first plane; and
a second anchoring member coupled to or integrated with
the second end of the torsion bar, the second anchoring member
having a third prong directly connected to the torsion bar at a
proximal end of the third prong and along the longitudinal axis
of the torsion bar, the second anchoring member having a fourth
prong directly connected to the torsion bar at a proximal end of
the fourth prong and along the longitudinal axis of the torsion bar
at the second end of the torsion bar, the third prong and the fourth
prong having a second length that is the same, the third prong
and the fourth prong lying in a second plane, wherein the torsion
bar includes a torque resistance such that an applied torque
resulting from a relative rotation of the first anchoring member
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Application 13/741,263

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and the second anchoring member rotates the torsion bar less
than 1°, the applied torque being less than or equal to 200 N-mm.

REFERENCES
The prior art relied upon by the Examiner are:
Name Reference Date
Krumme US 4,485,816 Dec. 4, 1984
Green US 4,610,250 Sept. 9, 1986
Wiedrich US 2009/0216233 A1 Aug. 27, 2009
Marczyk US 2010/0264192 A1 Oct. 21, 2010
Choinski US 2012/0203340 A1 Aug. 9, 2012

REJECTIONS
Claims 1–5, 21, 24, 25, 29, 31, 32, 36, 37, and 44–48 are rejected
under 35 U.S.C. § 103(a) as being unpatentable over Marczyk and Wiedrich.
Non-Final Act. 3.
Claims 8–12, 14, 26, and 27 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Choinski, Marczyk, and Green. Non-Final Act. 9.
Claims 30 and 38 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Marczyk and Green. Non-Final Act. 14.
Claims 34 and 35 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Marczyk, Wiedrich, and Krumme. Non-Final Act. 17.

OPINION
Independent claims 1, 8, and 30 require, among other limitations, a
torsional bar having: (1) a longitudinal axis in which “the longitudinal axis
of the torsion bar remains straight prior to insertion into a bone and after
insertion into a bone” and (2) “a torque resistance such that an applied
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torque resulting from a relative rotation of [a] first anchoring member and
[a] second anchoring member [of the torsional bar] rotates the torsion bar
less than 1°, the applied torque being less than or equal to 200 N-mm.”
Appeal Br. 29, 31, 34 (Claims App.).
In all of the rejections, the Examiner relies primarily on Marczyk for
at least a part of these limitations. Non-Final Act. 3–5, 10–11, 13–17. We
agree with Appellant that the Examiner errs in making the rejections for the
following three reasons.
First, the Examiner states that the longitudinal axis of Marczyk’s
torsional bar as depicted in Figure 9 and annotated by the Examiner,
“remains straight prior to insertion into a bone and after insertion into a bone
(considered functional).” See Non-Final Act. 3–4; see also id. at 10, 15. The
Examiner appears to disregard this limitation in stating that it “is considered
functional as the claims are directed to the device/system, rather than the
method,” and then states, and then replicates the limitation that “a
longitudinal axis is an axis/reference line that runs through the torsion bar
and would remain straight.” Ans. 4.
We agree with Appellant that this limitation (i.e., “remains straight”)
imparts at least some structural limitation in the torsional bar and cannot be
disregarded. See Appeal Br. 17–18. The reason being that in order to prevent
the torsional bar from being bent after the claimed device is inserted into the
bone, the torsional bar must have some characteristic to prevent being bent,
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whether it be a material strength or a dimensional feature, such as a
particular thickness––i.e., a structural limitation.2
We recognize, however, that whether the torsional bar is bent after the
claimed device is inserted into the bone depends on how it is inserted into
the bone––that is, there is a functional aspect in this limitation. For example,
if holes are drilled into the bone for insertion of the device, Marczyk’s
fastener 100 is capable of being inserted with little stress to the torsional bar,
such that its longitudinal axis remains straight thereafter.
Towards this end, “the patentability of apparatus or composition
claims depends on the claimed structure, not on the use or purpose of that
structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,
809 (Fed. Cir. 2002). “A patent applicant is free to recite features of an
apparatus either structurally or functionally . . . . Yet, choosing to define an
element functionally, i.e., by what it does, carries with it a risk.” In re
Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). Thus, “‘[f]unctional’
terminology may render a claim quite broad. By its own literal terms a claim
employing such language covers any and all embodiments which perform
the recited function.” In re Swinehart, 439 F.2d 210, 213 (CCPA 1971).
Further, “[i]f the prior art structure is capable of performing the intended

2 We note, however, that Marczyk’s device appears to be constructed for soft
tissue application (as it is used to sandwich tissue “T” between fastener 100
and looped member 200, as depicted in Figs. 5A–5C) and the Examiner does
not direct us to any passage where Marczyk applies its device to hard tissue–
–i.e., bone—in which forces applied to the device may differ for these two
different applications. Thus, Marczyk’s fastener 100 appears to have
structural requirements, i.e., a degree of torque resistance––if any, for soft
tissue application, rather than for hard tissue application.
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use, then it meets the claim.” In re Schreiber, 128 F.3d at 1478; see also In
re Swinehart, 439 F.2d at 213. Here, the Examiner appears to disregard this
limitation (both the structural aspect and the functional aspect of the
limitation) or fails to explain how the longitudinal axis of the torsional bar of
Marczyk’s device is capable of remaining straight after the device is inserted
into a bone.3
Second, the Examiner reasons that it would have been obvious to
modify Marczyk’s device to have the claimed torque resistance, because,
according to the Examiner, “the modified Marczyk’s device is analogous to
applicant’s device” and “discovering optimum or workable ranges involves
routine experimentation in the art.” See Non-Final 5; see also id. at 13, 16.
Appellant contends that Marczyk’s device is placed under tension
rather than torque and thus, a skilled artisan “would not be motivated to
modify” Marczyk’s device because that device “would not be placed under
an ‘applied torque,’” as claimed. Appeal Br. 17.
As a general rule, the discovery of an optimum value of a result
effective variable is ordinarily within the skill of the art, and thus usually
obvious. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007)
(citing In re Boesch, 617 F.2d 272, 276 (CCPA 1980)). But, before the

3 We do not opine whether the longitudinal axis of the torsional bar of
Marczyk’s device is capable of remaining straight after the device is inserted
into a bone or whether it would have been obvious to modify Marczyk’s
device to have this capability because the Patent Trial and Appeal Board is a
review body, rather than a place of initial examination; we leave it to the
Examiner to determine the appropriateness of any further course of action
should there be further prosecution of this application. Although the Board is
authorized to reject claims under 37 C.F.R. § 41.50(b), no inference should
be drawn when the Board elects not to do so. See MPEP § 1213.02
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determination of the optimum or workable ranges of a variable might be
characterized as routine experimentation, a particular parameter must first be
recognized as a result-effective variable. See In re Antonie, 559 F.2d 618
(CCPA 1977) (holding that the prior art did not recognize that treatment
capacity is a function of the tank volume to contractor ratio, and therefore
optimization of this parameter was not recognized in the art to be a result-
effective variable).
The Examiner may be correct in stating that “[t]orque resistance is
dependent on examples such as bone/tissue size (e.g.[,] infant versus an
adult) in which the device is applied to, the material of the device, the cross
sectional size of the material in which the device is applied to, and the
amount of applied torque applied.” Ans. 3–4; see also Non-Final Act. 5, 13,
17. Here, Marczyk’s device appears to be for soft tissue application rather
than hard tissue application, i.e., bone fixation.4 The Examiner does not
provide evidence or technical reasoning to explain that torque resistance is
desired and is a result-effective variable for Marczyk’s device.
Third, the Examiner states that “Applicant’s statements under [the]
‘Copying’ and ‘Commercial Success’ [arguments section] with respect to
BioMedical Enterprises and DePuy Synthes are not germane to the claims
presented nor the references cited.” Non-Final Act. 19; see also Ans. 4.
“A patent is invalid for obviousness ‘if the differences between the
subject matter sought to be patented and the prior art are such that the
subject matter as a whole would have been obvious at the time the invention
was made to a person having ordinary skill in the art to which said subject

4 See footnote 2 above.
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matter pertains.’” Wyers v. Master Lock Co., 616 F.3d at 1231, 1237 (Fed.
Reg. 2010) (quoting 35 U.S.C. § 103). “The underlying factual inquiries
include: (1) the scope and content of the prior art, (2) the differences
between the prior art and the claims at issue, (3) the level of ordinary skill in
the art, and (4) any relevant secondary considerations, such as commercial
success, long felt but unsolved needs, and the failure of others.” Id. (citing
Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). Our reviewing court
has held that evidence relating to all four Graham factors—including
objective evidence of secondary considerations—must be considered before
determining whether the claimed invention would have been obvious to one
of skill in the art at the time of invention. Transocean Offshore Deepwater
Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir.
2012). Further,
When prima facie obviousness is established and evidence is
submitted in rebuttal, the decision-maker must start over. . . . An
earlier decision should not, as it was here, be considered as set in
concrete, and applicant’s rebuttal evidence then be evaluated
only on its knockdown ability. . . . Facts established by rebuttal
evidence must be evaluated along with the facts on which the
earlier conclusion was reached, not against the conclusion itself.

In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984) (quoting In re
Rinehart, 531 F.2d 1048, 1052 (CCPA 1976)).
Accordingly, Appellant is correct in arguing that the “evidence of
copying and commercial success [as submitted by Appellant] are secondary
considerations which should be given weight in the analysis of the claims,
and may outweigh an otherwise obviousness combination of references.”
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Appeal Br. 19; see also id. at 20–25 (discussing the McIff Declaration5).
Although such evidence submitted by Appellant may not outweigh the facts
already in evidence, the newly submitted evidence along with the facts
already in evidence must be re-evaluated and the Examiner has failed to do
so here.6
As all of the Examiner’s rejections presently before us are predicated
on the above noted deficiencies, we reverse the Examiner’s rejections on the
record presently before us.

CONCLUSION
The Examiner’s rejections are reversed.
DECISION SUMMARY
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–5, 21, 24,
25, 29, 31,
32, 36, 37,
44–48
103(a) Marczyk, Wiedrich 1–5, 21,
24, 25, 29,
31, 32, 36,
37, 44–48
8–12, 14, 26,
27
103(a) Choinski, Marczyk,
Green
8–12, 14,
26, 27
30, 38 103(a) Marczyk, Green 30, 38
34, 35 103(a) Marczyk, Wiedrich,
Krumme
34, 35
Overall
Outcome
1–5, 8–12,
14, 21, 24–
27, 29–32,
34–38, 44–
48

5 Declaration of Terrance Edward McIff, submitted Aug. 29, 2018.
6 We decline to analyze the evidence of commercial success in the first
instance. See footnote 3 above.
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REVERSED