Ex parte Nichter

Board of Patent Appeals and Interferences

Apr 28, 1999

08185221 (B.P.A.I. Apr. 28, 1999)

Application for patent filed January 24, 1994. 1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was
not written for publication in a law journal and (2) is not binding
precedent of the Board.
Paper No. 29
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte LARRY S. NICHTER
____________
Appeal No. 96-2866
Application No. 08/185,2211
____________
HEARD: April 7, 1999
____________
Before McCANDLISH, Senior Administrative Patent Judge, COHEN,
and MEISTER, Administrative Patent Judges.
MEISTER, Administrative Patent Judge.
DECISION ON APPEAL
Larry S. Nichter (the appellant) appeals from the final
rejection of claims 20-26, the only claims remaining in the
application.
Appeal No. 96-2866 Page 2
Application No. 08/185,221
We REVERSE and, pursuant to our authority under the
provisions of 37 CFR § 1.196(b), we will enter new rejections
of the appealed claims.
The appellant's invention pertains to a method for
fixating a bone by utilizing a wire having a cutting means
disposed on one end thereof. Independent claim 20 is further
illustrative of the appealed subject matter and a copy thereof
may be found in the appendix to the brief.
The prior art relied on by the examiner is:
Longfellow 2,143,922 Jan. 17, 1939
Leuenberger 4,111,208 Sep. 5, 1978
Bray 4,596,243 Jun. 24,
1986
Additional prior art relied on by this merits panel of the
Board is:
The prior art depicted in Fig. 5 of the drawings and described
on pages 1 and 8 of the specification (the admitted prior art).
Claims 20, 22, 24 and 26 stand rejected under 35 U.S.C. §
103 as being unpatentable over Longfellow in view of
Leuenberger.
Appeal No. 96-2866 Page 3
Application No. 08/185,221
According to appellant's specification "K-wires" (i.e.,2
Kirscher wires) are fixation wires which typically have two to
four cutting edges on one end thereof (see page 6, lines 7 and
8) and are traditionally inserted or drilled into bone tissue
by means of a rotary drill (see page 1, lines 8-26).
Claims 21, 23 and 25 stand rejected as being unpatentable
over Longfellow in view Leuenberger as applied to claims 20 and
24 above, and further in view of Bray.
Both of the above-noted rejections are bottomed on the
examiner's view that:
Longfellow discloses a wire having a cutting edge
that is placed in a bone as a fixation element (see
Longfellow's figure 1 and appellant's specification
pages 5 and 6 for a further discussion of these
wires). Longfellow discloses that the wires are2
inserted into and through the bone by drilling the
wires into the bones in the normal manner (see
appellant's specification, for a discussion on the
normal ways of inserting these wires). However,
Longfellow does not disclose that the wire is
oscillated during its insertion. [Answer, page 4;
footnote added.]
Thereafter, the examiner concludes that it would have been
obvious to modify the insertion method of Longfellow by
oscillating the fixation wires in view of the teachings of
Leuenberger.
In our view, the examiner's position is based on
speculation and unfounded assumptions. There is absolutely
Appeal No. 96-2866 Page 4
Application No. 08/185,221
nothing in Longfellow which either teaches or fairly suggests
that the wires 33 and 34 are Kirscher-type wires and "are
inserted into and through the bone by drilling the wires into
the bones in the normal matter" as the examiner asserts.
Longfellow makes no mention of Kirscher wires and merely
broadly states that "wires" are "inserted" through the bone
fragments (see column 1, lines 39 and 40; column 2; lines 26
and 27). It does not follow that just because it is known in
the art to drill Kirscher wires into bones by utilizing a
rotary drill, that the "wires" 33 and 34 of Longfellow are
likewise drilled into bones. Insofar as the broad statements
in Longfellow that the wires 33 and 34 are "inserted" through
the bone fragments are concerned, holes may have been first
drilled through the bone fragments by a drill bit and the wires
thereafter inserted through the holes. Moreover, it is not
apparent that the wires of Longfellow even have the capability
of being drilled into bones by means of a rotary drill. That
is, there is no indication that the wires 33 and 34 have
cutting edges or similar elements which would provide such
capability. Obviousness under § 103 is a legal conclusion
based on factual evidence (In re Fine, 837 F.2d 1071, 1073, 5
Appeal No. 96-2866 Page 5
Application No. 08/185,221
USPQ2d 1596, 1598 (Fed. Cir. 1988)) and the examiner may not
resort to speculation or unfounded assumptions to supply
deficiencies in establishing a factual basis (see In re Warner,
379 F.2d 1011, 1017, 154 USPQ 173, 178 (CCPA 1967)).
While both Leuenberger and Bray teach the drilling of
holes in bones by the means of oscillating drill bits, there is
nothing in either of these references which overcomes the
deficiencies of Longfellow that we have noted above. This
being the case, we will not sustain the rejections under 35
U.S.C. § 103 of claims 20, 22, 24 and 26 under 35 U.S.C. § 103
based on the combined teachings of Longfellow and Leuenberger
and claims 21, 23 and 25 based on the combined teachings of
Longfellow, Leuenberger and Bray.
Under the provisions of 37 C.F.R. § 1.196(b) we make the
following new rejections:
Claims 20-26 are rejected under 35 U.S.C. § 112, first
paragraph, as being based upon an original disclosure which
fails to provide descriptive support for the subject matter now
being claimed. We initially observe that the description
requirement found in the first paragraph of 35 U.S.C. § 1l2 is
separate from the enablement requirement of that provision.
Appeal No. 96-2866 Page 6
Application No. 08/185,221
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560-64, 19
USPQ2d 1111, 1114-17 (Fed. Cir. 1991) and In re Barker, 559
F.2d 588, 591, 194 USPQ 470, 472 (CCPA 1977), cert. denied, 434
U.S. 1238 (1978). With respect to the description requirement,
the court in Vas-Cath, Inc. v. Mahurkar at 935 F.2d 1563-64, 19
USPQ2d 1117 stated:
35 U.S.C. § 112, first paragraph, requires a "written
description of the invention" which is separate and
distinct from the enablement requirement. The
purpose of the "written description" requirement is
broader than to merely explain how to "make and use";
the applicant must also convey with reasonable
clarity to those skilled in the art that, as of the
filing date sought, he or she was in possession of
the invention. The invention is, for purposes of the
"written description" inquiry, whatever is now
claimed.

. . . drawings alone may be sufficient to provide the
"written description of the invention"
required by
§ 112, first paragraph.
It is also well settled that the question of whether a
modification is an obvious variant of that which is originally
disclosed is irrelevant insofar as the written description
requirement is concerned. See, e.g., Lockwood v. American
Airlines Inc., 107 F.3d 1565, 1571-72, 41 USPQ2d 1961, 1966
Appeal No. 96-2866 Page 7
Application No. 08/185,221
The American Heritage Dictionary, Second College3
Edition, 1982, Houghton Mifflin Company, Boston, MA, defines
"necrosis" as -- The pathologic death of living tissue in a
plant or animal --.
(Fed. Cir. 1997) and In re Wohnsiedler, 315 F.2d 934, 937, 137
USPQ 336, 339 (CCPA 1963). See also In re Barker, 559 F.2d at
593, 194 USPQ at 474, wherein the court, in quoting with
approval from In re Winkhaus, 527 F.2d 637, 640, 188 USPQ 129,
131 (CCPA 1975) set forth: “That a person skilled in the art
might realize from reading the disclosure that such a step is
possible is not a sufficient indication to that person that the
step is part of appellants’ invention.”
With these authorities in mind, we have carefully reviewed
the original disclosure and fail to find descriptive support
for the recitation in independent claim 20 of the step of
selecting said selected oscillating frequency and
said selected force to minimize temperature elevation
and thermal necrosis of said bone and its surrounding3
tissue. [Footnote added.]
It is stated on page 7 of the specification that
less force is required utilizing the method of the
present invention as is necessary for the advancement
of the wire when the wire is rotated in accordance
with the prior art, at a speed equal to the
oscillation frequency of the wire 16. The
Appeal No. 96-2866 Page 8
Application No. 08/185,221
oscillation frequency may be varied and is dependent
upon many factors. However, it has been found that
when the wire is oscillated at about 1200
oscillations per minute during advancement into the
bone tissue, successful fixation may be obtained.
Page 8 of the specification also states
that the method in accordance with the present
invention, utilizing an oscillating drill, generates
less temperature elevation and less thermal damage.
The apparatus and method of the present invention
also may enable the insertion of K-wires at the same
insertional force but lower rotational speeds, or
vice versa, in order to reduce temperature elevation
during drilling. This may have the beneficial result
of causing less complications from thermal damage and
a stronger wire holding strength over time.
It does not follow, however, that just because the
specification states that (1) less force is required when the
Kirscher wires are oscillated rather than rotated, (2) the
oscillation frequency may be varied, (3) utilizing an
oscillating drill generates less temperature elevation and less
thermal damage and (4) the same force but lower rotational
speeds, or vice versa, may reduce temperature elevation, that
the appellant was in possession at the time of the filing of
the application of the step of selecting the oscillating
Appeal No. 96-2866 Page 9
Application No. 08/185,221
According to pages 10-12 of the specification three4
different-sized trocar-tipped Kirscher or K-wires (0.028,
0.045 and 0.062 inches in diameter) were evaluated for
drilling force and pull-out force on the tibias of two
rabbits. With respect to this evaluation the specification
states that:
Five new K-wires for each size were tested on
three tibias using either the rotary or oscillating
drill. Each tibia had ten drilled holes, 4mm apart,
equally spaced along the mid-diaphysis. The SAS t-
test was used to evaluate the differences in mean
peak axial loads and mean peak pull-out forces for
thirty point configurations for the two drills.
[Pages 10 and 11.]
frequency and force to minimize temperature elevation and
thermal necrosis as claimed.
There is further no descriptive support for the recitation
in independent claim 24 that the "fixation wire" (which as
broadly recited includes all such wires) requires
"comparatively more force" for removal from the bone than would
be required for such a wire that was inserted by rotation.
Fig. 8 of the drawing is directed to a bar chart that provides
a comparative showing of the mean peak pull out force for each
of three wires of different diameter. This comparative4
showing reveals that the mean peak pull out force for the
Kirscher wires installed by a rotary drill are in some cases
Appeal No. 96-2866 Page 10
Application No. 08/185,221
greater than those installed by an oscillating drill. Thus,
there is no descriptive support that the "fixation wire" (which
as broadly recited includes all fixation wires) requires
"comparatively more force for removal" as independent claim 24
sets forth. In this regard, it should be noted that there is a
lack of descriptive support for claims which set forth
essential elements of the invention in terms which are broader
than the supporting disclosure. See Gentry Gallery, Inc. v.
Berkline Corp., 134 F.3d 1473, 1480, 45 USPQ2d 1498, 1503 (Fed.
Cir. 1998).
Claims 24-26 are rejected under 35 U.S.C. § 112, first
paragraph, as being based on a non-enabling disclosure. We
initially observe that the test regarding enablement is whether
the disclosure, as filed, is sufficiently complete to enable
one of ordinary skill in the art to make and use the claimed
invention without undue experimentation. In re Scarbrough, 500
F.2d 560, 566, 182 USPQ 298, 302 (CCPA 1974) and In re Wands,
858 F.2d 731, 737 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The
experimentation required, in addition to not being undue, must
not require ingenuity beyond that expected of one of ordinary
Appeal No. 96-2866 Page 11
Application No. 08/185,221
skill in the art. In re Angstadt, 537 F.2d 498, 504, 190 USPQ
214, 218 (CCPA 1976). Moreover, the specification must teach
those of skill in the art how to make and use the invention as
broadly as it is claimed. See In re Goodman, 11 F.3d 1046,
1050, 29 USPQ2d 2010, 2013 (Fed. Cir. 1993).
Here, as we have noted above in the rejection of these
claims based on a lack of descriptive support, independent
claim 24 sets forth that the "fixation wire" (which as broadly
recited includes all such wires) requires "comparatively more
force" for removal from the bone than would be required for a
fixation wire that was inserted by rotation. The appellant's
disclosure provides no adequate teaching of how all fixation
wires may installed or inserted in such a manner so as to
require "comparatively more force for removal" from the bone
than would be required for a fixation wire installed by
rotation. According to the comparative showing in Fig. 8, the
appellant's disclosed method, at the most, will result in only
some the fixation wires (dependent upon the particular diameter
and particular location on the tibia) requiring comparatively
more force for removal.
Appeal No. 96-2866 Page 12
Application No. 08/185,221
Claims 20 and 21 are rejected under 35 U.S.C. § 103 as
being unpatentable over the admitted prior art in view of
Leuenberger. The admitted prior art teaches a method of
fixating bone by means of a wire having a cutting means at one
end thereof comprising the steps of (1) unidirectionally
rotating the wire, (2) pressing one end of the wire with a
force that causes the wire to penetrate the bone and (3)
fixating the bone with the wire, wherein the wire remains in
the bone for a period of time sufficient for the bone to heal.
Leuenberger, however, teaches that, when drilling bone with a
unidirectional rotatable movement of a boring or drilling
implement, damage of surrounding soft portions of the body may
occur (see column 1, lines 14-22). In order to overcome this
problem, Leuenberger teaches that the drilling implement
(albeit a drill, miller or broaching tool; see column 1, line
32) should be advanced through the bone utilizing an
alternating or oscillating movement (rather than unidirectional
rotary movement). Leuenberger in lines 25-42 of column 1
reveals that, not only does such oscillating movement prevent
damage of the soft tissue due to the motion of the tool or
implement, but that it also diminishes heating to a large
Appeal No. 96-2866 Page 13
Application No. 08/185,221
degree (thus diminishing the risk of modification of the
cellular structure, notably bone). In light of Leuenberger's
teachings, one of ordinary skill in this art would have found
it obvious to oscillate the fixation wire of the admitted prior
art in order to achieve Leuenberger's expressly stated
advantages of (1) avoiding damage to surrounding soft tissue
caused by unidirectional rotation of the drilling implement and
(2) diminishing the amount of heat generated to a large degree
(thus diminishing the risk of modification of the cellular
structure of the bone).
As to the step of selecting the oscillating frequency and
the force so as to "minimize" temperature elevation and thermal
necrosis of the bone, the selection of an optimum value is
ordinarily an obvious matter which is within the skill of the
art. Note In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934,
1936-37 (Fed. Cir. 1990), In re Boesch, 617 F.2d 272, 276, 205
USPQ 215, 219 (CCPA 1980), In re Fields, 304 F.2d 691, 695-96,
134 USPQ 242, 245 (CCPA 1962), In re Troiel, 274 F.2d 944, 949,
124 USPQ 502, 505 (CCPA 1960) and In re Aller, 220 F.2d 454,
456, 105 USPQ 233, 235 (CCPA 1955).
Appeal No. 96-2866 Page 14
Application No. 08/185,221
As to the particular frequency of "about 1200 oscillations
per minute" as set forth in claim 25, the specification sets
forth this parameter as "a specific example" (page 3) and
further states that the "oscillation frequency may be varied
and is dependent upon many factors" (page 7). Since the
provision of an oscillation frequency of about 1200
oscillations per minute appears to solve no stated problem
insofar as the record is concerned, we conclude that such a
provision obvious is a matter engineering design choice. See
In re Kuhle, 526 F.2d 553, 555, 188 USPQ 7, 9 (CCPA 1975).
As evidence of nonobviousness the appellant has relied on
declarations by Ashworth, Body and Talesisnik. Each of these
declarations state essentially the same thing. Paragraphs 4
and 5 of each declaration states that the declarant is familiar
with the references to Longfellow, Leuenberger and Bray which
were relied on by the examiner and concludes that it would not
have been obvious to insert an oscillating K-wire into bone in
view of these teachings. Here, however, we have relied on the
combined teachings of the admitted prior art and Leuenberger,
rather than the specific reference combination relied on by the
Appeal No. 96-2866 Page 15
Application No. 08/185,221
It is well established that evidence of non-obviousness5
must be commensurate in scope with the claims which the
evidence is offered to support. See In re McLaughlin, 443
F.2d 1392, 1396, 170 USPQ 209, 213 (CCPA 1971), In re Tiffin,
448 F.2d 791, 792, 171 USPQ 294 (CCPA 1971), and In re
Thompson, 545 F.2d 1290, 1295, 192 USPQ 275, 277 (CCPA 1976).
examiner. Additionally, the statement regarding an oscillating
K-wire is not commensurate with the scope of the claimed
subject matter inasmuch as the claims on appeal more broadly
recite "a wire." Moreover, while it is proper to give some5
weight to a persuasively supported statement of one skilled in
the art on what was not obvious to him, obviousness is a
question of law which we must decide (see In re Weber, 341 F.2d
143, 145, 144 USPQ 495, 497 (CCPA 1965) and In re Vamco Machine
and Tool, Inc., 752 F.2d 1564, 1574-75, 224 USPQ 617, 623 (Fed.
Cir. l985)), and an expert's opinion on the legal conclusion of
obviousness is neither necessary nor controlling (see Avia
Group Int’l, Inc. v. L.A. Gear Cal.,Inc., 853 F.2d 1557, 1564,
7 USPQ2d 1548, 1554 (Fed. Cir. 1988)).
Paragraph 6 of each declaration states that it is
"surprising" that less force is required to insert a wire by
oscillation than by rotation and it is "even more unexpected"
Appeal No. 96-2866 Page 16
Application No. 08/185,221
that a wire which was oscillated would have comparatively
greater holding strength than one inserted by rotation. These
statements, are once again not commensurate in scope with the
claimed subject matter. That is, there is no requirement in
claims 20 and 21 that the wire be advanced with a force that is
less than that required by a rotary drill or that the fixation
wire requires comparatively more force for removal than a
fixation wire inserted by rotation. Moreover, these statements
are merely conclusory in nature and it is unclear what the
declarant's conclusions are based on. Affidavits and declara-
tions fail in their purpose when they recite conclusions with
few facts to buttress the conclusions. See In re Brandstadter,
484 F.2d 1395, 1406, 179 USPQ 286, 294 (CCPA 1973), In re
Thompson, supra, and In re DeBlauwe, 736 F.2d 699, 705, 222
USPQ 191, 196 (Fed. Cir. 1984). We also observe that, if the
"even more unexpected" result of the oscillating wire having
comparatively greater holding strength is based on the
comparative showing in Fig. 8 of the drawings, then a
comparatively greater holding strength is achieved only with
respect to certain size wires at certain locations, rather than
Appeal No. 96-2866 Page 17
Application No. 08/185,221
"wires" in general as claimed. Moreover, the specification
states that this value "does not appear to be statistically
significant" (page 11, lines 12 and 13).
In summary:
The examiner's rejections of claims 20-26 under 35 U.S.C.
§ 103 are reversed.
New rejections of claims 20-26 under 35 U.S.C. § 112,
first paragraph, and claims 20 and 21 under 35 U.S.C. § 103
have been made.
This decision contains new grounds of rejection pursuant
to 37 C.F.R. § 1.196(b)(amended effective Dec. 1, 1997, by
final rule notice, 62 Fed. Reg. 53,131, 53,197 (Oct. 10, 1997),
1203 Off. Gaz. Pat. & Trademark Office 63, 122 (Oct. 21,
1997)). 37 C.F.R. § 1.196(b) provides that, “A new ground of
rejection shall not be considered final for purposes of
judicial review.”
37 C.F.R. § 1.196(b) also provides that the appellant,
WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new
Appeal No. 96-2866 Page 18
Application No. 08/185,221
grounds of rejection to avoid termination of proceedings
(§ 1.197(c)) as to the rejected claims:
(1) Submit an appropriate amendment of the
claims so rejected or a showing of facts relating to
the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the
application will be remanded to the examiner. . . .
(2) Request that the application be reheard
under § 1.197(b) by the Board of Patent Appeals and
Interferences upon the same record. . . .
No time period for taking any subsequent action in
connection with this appeal may be extended under 37 C.F.R.
§ 1.136(a).
REVERSED
37 C.F.R. § 1.196(b)
Appeal No. 96-2866 Page 19
Application No. 08/185,221
HARRISON E. McCANDLISH )
Senior Administrative Patent Judge
)
)
)
)
) BOARD OF PATENT
IRWIN CHARLES COHEN ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
JAMES M. MEISTER )
Administrative Patent Judge )
Whitham & Marhoefer
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