Ex Parte Mikol et al

Board of Patent Appeals and Interferences

Nov 30, 2011

12100102 (B.P.A.I. Nov. 30, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte EDWARD JOHN MIKOL and THOMAS JOHN CHAMBERS
____________

Appeal 2011-009762
Application 12/100,102
Technology Center 3700
____________

Before STEFAN STAICOVICI, GAY ANN SPAHN, and
MICHAEL C. ASTORINO, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE
Edward J. Mikol and Thomas J. Chambers (Appellants) appeal under
35 U.S.C. § 134 from the Examiner’s decision rejecting under 35 U.S.C. §
102(b) claims 1, 2, 15-17, 22, 23, 31, and 35 as anticipated by Ender (US
4,475,545, issued Oct. 9,1984) and under 35 U.S.C. § 103(a) claim 30 as
unpatentable over Ender and claims 3, 18-20, and 32-34 as unpatentable
over Ender and Seidel (US 4,858,602, issued Aug. 22, 1989).1 Appellants
present additional evidence in the Declarations filed under 37 C.F.R. § 1.131
of Edward J. Mikol, filed on Aug. 9, 2010 (hereafter the “Mikol
Declaration”) and of Thomas J. Chambers, filed on Oct. 7, 2010 (hereafter
the “Chambers Declaration”).
The present application is a reissue application of U.S. Patent No.
5,776,194 (hereafter “Mikol”), issued Jul. 7, 1998 from Application No.
08/638,940, filed Apr. 25, 1996. Appellants’ representative presented oral
argument on Oct. 20, 2011. We have jurisdiction over this appeal under 35
U.S.C. § 6.

THE INVENTION
Appellants’ invention relates to a bone stabilizing apparatus including
a stem member 1, an extension member 2, and pressure-type or suture type
stabilizing screws 22 and 24 having a non-threaded portion 22c and 24c,
respectively, and a threaded portion that engages with threaded passages 20

1 Claims 12-14 have been allowed and claims 4-9, 21, 24-29, 36, and 37
have been withdrawn by the Examiner. Claims 10 and 11 are objected to by
the Examiner as being dependent upon a rejected base claim and otherwise
indicated as being allowable if rewritten in independent form including all of
the limitations of the base claim and any intervening claim.
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in extension member 2. Mikol, 5: 37-41, 6: 51-56, 8: 35-40 and figs. 1, 2A,
and 2C.
Claims 1 and 31 are representative of the claimed invention and read
as follows:
1. A bone stabilizing device, comprising:
a stem member, extending substantially along a first
longitudinal axis, for insertion into a medullary bone cavity, said stem
member having a distal end and a proximal end;
[[an]] a substantially cylindrical extension member positioned
substantially outside of the medullary bone cavity, extending
substantially along a second longitudinal axis, having a distal and a
proximal end, said distal end connected to said proximal end of said
stem member; and
means for securing a fractured metaphyseal or epiphyseal bone
to said extension member comprising a securing member having a
first end [[affixed into]] mechanically attached to the extension
member, and a second end spaced apart from said extension member,
and means connected to said second end for pressing on a cortical
surface of the bone to urge the bone against said extension member,
wherein a third longitudinal axis of the securing member is unaligned
with the second longitudinal axis of the extension member.

31. An intramedullary device comprising
a distal portion extending substantially along a first longitudinal
axis and
a substantially cylindrical proximal portion extending
substantially along a second longitudinal axis, wherein the distal
portion is connected to the proximal portion,
wherein the distal portion is adapted to be inserted into a
medullary cavity, and the proximal portion is positioned substantially
outside of the medullary cavity,
wherein at least one screw having a head and a threaded portion
forms an urging attachment with the proximal portion to urge a
fractured metaphyseal or epiphyseal bone to the proximal portion to
stabilize the fractured metaphyseal or epiphyseal bone,
wherein the threaded portion of the at least one screw is
threaded to a corresponding threaded hole in the proximal portion of
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the intramedullary device and the head of the screw is positioned to
urge the metaphyseal or epiphyseal bone and proximal portion toward
each other;
wherein a third longitudinal axis of the at least one screw is
unaligned with the second longitudinal axis of the proximal portion.

SUMMARY OF DECISION
We AFFIRM-IN-PART.

ANALYSIS
Claims 1, 2, 15-17, 22, and 23
Independent claim 1 recites two means-plus-function limitations.
Specifically, claim 1 recites “means for securing a fractured metaphyseal or
epiphyseal bone to said extension member comprising [(1)] a securing
member…and [(2)] means…for pressing on a cortical surface of the bone to
urge the bone against said extension member.” App. Br., Claims Appendix.
“[T]he ‘broadest reasonable interpretation’ that an examiner may give
means-plus-function language is that statutorily mandated in paragraph six
[of 35 U.S.C. § 112]. Accordingly, the PTO may not disregard the structure
disclosed in the specification corresponding to such language when
rendering a patentability determination.” In re Donaldson Co., 16 F.3d
1189, 1194-95 (Fed. Cir. 1994) (en banc).
The plain and unambiguous meaning of [35 U.S.C.
§ 112] paragraph six is that one construing means-
plus-function language in a claim must look to the
specification and interpret that language in light of
the corresponding structure, material, or acts
described therein, and equivalents thereof, to the
extent that the specification provides such
disclosure.
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Id. at 1193.
“The first step in the construction of a means-plus-function claim
element is to identify the particular claimed function. The second step in the
analysis is to look to the specification and identify the corresponding
structure for that function.” (Citations omitted). Med. Instrumentation &
Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1210 (Fed. Cir. 2003).
We find that (1) the language of claim 1 invokes 35 U.S.C. § 112,
sixth paragraph, for the phrase “means for securing …comprising a securing
member,” (2) the recited function is “for securing a fractured metaphyseal or
epiphyseal bone to said extension member …to urge the bone against said
extension member,” and (3) Appellants have supplied the structure
corresponding to the recited function, pressure-type or suture type stabilizing
screws 22 and 24 having a non-threaded portion 22c and 24c, respectively.
Accordingly, the phrase “means for securing …comprising a securing
member,” as called for in independent claim 1, will be construed as
encompassing a screw having a non-threaded portion or its equivalents.
In a first instance, the Examiner found that screw 21 of Ender “is
capable of securing a fractured metaphyseal or epiphyseal bone to the
extension member.” Ans. 3. Appellants contend that because screw 21 of
Ender does not have a threaded portion, it does not “allow the fractured bone
to move relative to the bone nail.” App. Br. 15. See also, App. Br. 8-9. We
agree.
Ender teaches a bone-nail for treating fractures including a base
member 1 (stem member), a head 3 (extension member), and screw bolts 21
that are screwed into threaded hole pairs 14′, 14″ and 15′, 15″. Ender, col. 3,
ll. 101-2; col. 4, ll. 45-50; and figs. 4 and 5. We could not find any portion
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of Ender, and the Examiner has not indicated any portion of Ender, that
teaches a non-threaded portion on bolt screws 21. Moreover, as far as we
can tell, Figures 4 and 5 of Ender show that screw bolts 21 have only a
threaded portion. Hence, although we appreciate that screw bolts 21 of
Ender are capable of “securing a fractured metaphyseal or epiphyseal bone
to said extension member,” since screw bolts 21 do not appear to include a
non-threaded portion, we agree with Appellants that screw bolts 21 are not
capable ‘to urge the bone against said extension member,” as called for by
independent claim 1. See App. Br. 15. Therefore, screw bolts 21 of Ender
do not constitute a screw having a non-threaded portion.
As an alternative, pointing to Page 10 of the Appeal Brief, the
Examiner found that:
[A]n ‘equivalent under 35 U.S.C. § 112, sixth
paragraph, may instead involve “[c]learance holes
that are sufficiently large to allow any screw to
pass through [and] not fix the position of the screw
to the walls of the hole thereby establishing a
‘lagging’ connection … Since the appealed claims
do not positively set forth (as an element) a bone
or bone fragment having a hole of a particular
diameter and since the Ender securing means 21 is
certainly capable of passing through a clearance
hole formed in a metaphyseal and/or epiphyseal
bone fragment or fracture, the Ender device
possesses all of the structure underlying the
language (functional or otherwise) of the rejected
claims.
Ans. 4-5.
In other words, the Examiner appears to take the position that for the
purposes of 35 U.S.C. § 112, sixth paragraph, a clearance hole and a screw
having only a threaded portion together constitute an equivalent structure to
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a screw having a non-threaded portion because both can form a “lagging
connection.” However, although we appreciate that a screw having only a
threaded portion is capable of establishing a “lagging connection” if passed
through a clearance hole, nonetheless, we could not find any portion of
Ender and the Examiner has not pointed to any portion that teaches passing
screw bolt 21 through a clearance hole in bone 18. As such, the Examiner’s
finding that Ender’s screw bolts 21 are passed through clearance holes in
bone 18 prior to being screwed into threaded hole pairs 14′, 14″ and 15′, 15″
is mere speculation and conjecture. Hence, we agree with Appellants that
because screw bolt 21 of Ender does not pass through a clearance hole it
does not “allow the fractured bone to move relative to the bone nail.” App.
Br. 15.
In conclusion, for the reasons set forth above, bolt screws 21 of Ender
do not constitute a screw having a non-threaded portion or its equivalents, so
as to satisfy the “means for securing …comprising a securing member”
limitation of independent claim 1. Accordingly, the rejection of claims 1, 2,
15-17, 22, and 23 under 35 U.S.C. § 102(b) as anticipated by Ender cannot
be sustained.

Claims 31 and 35
Independent claim 31 requires, inter alia, “at least one screw having a
head and a threaded portion form[ing] an urging attachment with the
proximal portion [of an intramedullary device] to urge a fractured
metaphyseal or epiphyseal bone to the proximal portion to stabilize the
fractured metaphyseal or epiphyseal bone.” App. Br., Claims Appendix.
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The Examiner found that because bolt screw 21 of Ender “is
structurally capable of sliding through a slightly larger bone fragment
clearance hole,” Ender’s screw is capable of forming a “lagging
connection” for “securing a fractured metaphyseal or epiphyseal bone to the
extension member.” Ans. 3, 5, and 6. In other words, the Examiner appears
to take the position that because screw bolt 21 is capable of passing through
a clearance hole, it can “urge a fractured metaphyseal or epiphyseal bone to
the proximal portion [of an intramedullary device],” as called for by
independent claim 31.
Appellants argue that, “Ender does not describe an urging attachment
… [and] that the possibility that someone may alter the Ender nail to a
lagging attachment is insufficient to establish the inherency of that
attachment.” App. Br. 18.
We disagree with Appellants’ position because the Examiner is not
proposing to alter Ender’s nail. Rather the Examiner appears to take the
position that Ender’s nail and screw bolts 21 are merely capable of forming
an “urging attachment … to urge a fractured metaphyseal or epiphyseal bone
to the proximal portion.”
At the outset, we recognize that the limitation “to urge a fractured
metaphyseal or epiphyseal bone to the proximal portion [of an
intramedullary device] to stabilize the fractured metaphyseal or epiphyseal
bone” is a functional limitation. It is well settled that while features of an
apparatus may be recited either structurally or functionally, claims directed
to an apparatus must be distinguished from the prior art in terms of structure
rather than function. In re Schreiber, 128 F.3d 1473, 1477-78 (Fed. Cir.
1997).
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In this case, we agree with the Examiner that Ender teaches each of
the claimed structural limitations including a nail and at least one screw bolt
21 having a threaded portion and a head. Ans. 5. See also, Ender, col. 3, ll.
10-12; col. 4, ll. 45-50; and fig. 5. On the other hand, we also agree with
Appellants that Ender does not teach that screw bolts 21 and Ender’s nail
form an “urging attachment … to urge a fractured metaphyseal or epiphyseal
bone to the proximal portion,” as called for by claim 31. Hence, the only
distinguishing aspect of the claimed intramedullary device is that of an
“urging attachment … to urge a fractured metaphyseal or epiphyseal bone to
the proximal portion.” Under Schreiber, this distinction is not a patentable
one. Since the oil spout in Schreiber was “capable of” dispensing popcorn
in the manner set forth in the claim, it inherently satisfied all of the
functional limitations and anticipated the claimed popcorn spout. See
Schreiber, 128 F. 3d at 1478-79. Similarly, in this case, since the bone-nail
and screw bolt 21 of Ender is capable of forming an “urging attachment …
to urge a fractured metaphyseal or epiphyseal bone to the proximal portion”
when used in conjunction with a clearance hole in a bone, we find that the
bone-nail and screw bolts 21 of Ender anticipates the claimed intramedullary
device. See also Ans. 5 and 6.
Hence, the Examiner is not proposing to alter the bone-nail and screw
bolts 21 of Ender, as Appellants appear to contend, but merely to show that
the bone-nail and screw bolt structure of Ender is capable of performing the
recited function, regardless of whether Ender specifically teaches clearance
holes in bone 18. Moreover, as noted by the Examiner, claim 31 does not
positively recite a clearance hole in a bone. Ans. 5. As long as Ender’s
structure is capable of performing the recited function, Ender’s structure
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satisfies the claimed intramedullary device. Where all structural elements of
a claim exist in a prior art product, and that prior art product is capable of
satisfying all functional or intended use limitations, the claimed invention is
nothing more than an unpatentable new use for an old product. Schreiber,
128 F.3d at 1477.
In conclusion, for the foregoing reasons, the rejection of claim 31
under 35 U.S.C. § 102(b) as anticipated by Ender is sustained.
With respect to claim 35, Appellants argue that it is “patentable due to
its dependency on claim 1.” App. Br. 25. However, claim 35 depends from
independent claim 31. App. Br., Claims Appendix. Since Appellants do not
present any other substantive arguments, the rejection of claim 35 is likewise
sustained.

Claims 32-34
Appellants argue that because bolt screws 21 of Ender do not urge the
fractured bone to the nail, “there is no need to use a washer to distribute the
urging force.” Furthermore, Appellants opine that because “[t]he excerpts
from the Campbell textbook … shows that no washer is used with bone
screws,” a person ordinarily skilled in the art would also not use a washer
with a bone screw as in Ender. App. Br. 25.
At the outset, we note that neither of claims 32-34 require the claimed
“washer” to “distribute the urging force.” Furthermore, although the
Campbell textbook does not show a washer in conjunction with a bone
screw (see App. Br., Appendix 3, fig. 49-27), the reason to modify a
reference may often prompt a person of ordinary skill in the art to do what
the inventor has done, but for a different purpose or to solve a different
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problem. It is not necessary that the prior art suggest the combination to
achieve the same advantage or result discovered by an applicant. See, e.g., In
re Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006).
Moreover, 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. KSR Int’l. Co. v. Teleflex Inc.,
550 U.S. 398, 417 (2007). In determining whether the subject matter of a
claim is obvious, “neither the particular motivation nor the avowed purpose
of the [applicant] controls. What matters is the objective reach of the
claim.” If the claim extends to what is obvious, it is unpatentable under
§ 103. Id., at 419.
In this case, the Examiner concluded that adding the claw washer of
Seidel to the device of Ender “would have been an obvious supplement for
the bolt 21 of Ender in order to better grip around and distribute stresses
across the bone fragment.” Ans. 4. Hence, we find that the Examiner has
provided an adequate reasoning with rational underpinning to supplement
the screw bolt 21 of Ender with the claw washer of Seidel.

The Mikol Declaration and the Chambers Declaration
We are not persuaded by the Mikol and Chambers Declarations
because they do not present any substantive arguments with respect to the
Examiner’s rejections. For example, the Mikol Declaration merely tries to
show that the date of invention was as early as May 6, 1994. Mikol
Declaration, ¶¶ 9-16. The Chambers Declaration merely agrees with the
facts set forth in ¶¶ 9-16 of the Mikol Declaration.
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Claims 3, 18-20, and 30
With respect to claim 30, the Examiner’s proposed modification of
Ender does not remedy the deficiencies of Ender as described above.
Accordingly, the rejection of claim 30 under 35 U.S.C. § 103(a) as
unpatentable over Ender cannot be sustained.
Finally, regarding claims 3 and 18-20, the addition of Seidel does not
remedy the deficiencies of Ender as described above. Therefore, the
rejection of claims 3 and 18-20 under 35 U.S.C. § 103(a) as unpatentable
over Ender and Seidel likewise cannot be sustained.

SUMMARY
The decision of the Examiner is affirmed as to claims 31-35 and
reversed as to claims 1-3, 15-20, 22, 23, and 30.

AFFIRMED-IN-PART

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