Ex Parte Siravo et al

Patent Trial and Appeal Board

Apr 27, 2017

12524427 (P.T.A.B. Apr. 27, 2017)

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.
10139/14914 8699
EXAMINER
JOHANAS, JACQUELINE T
ART UNIT PAPER NUMBER
3733
MAIL DATE DELIVERY MODE
12/524,427 07/24/2009
76960 7590
Fay Kaplun & Marcin, LLP
150 Broadway, suite 702
New York, NY 10038
Mark Siravo
04/28/2017 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 MARK SIRAVO and GLEN PIERSON
Appeal 2015-004771
Application 12/524,427
Technology Center 3700
Before: JENNIFER D. BAHR, LEE L. STEPINA, and
SEAN P. O’HANLON, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants1 appeal under 35 U.S.C. § 134 from the Examiner’s
decision to reject claims 1, 12—25, 27, 28, and 32—38. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify DePuy Synthes Products, LLC as the real party in
interest. Appeal Br. 2.
Appeal 2015-004771
Application 12/524,427
CLAIMED SUBJECT MATTER
The claims are directed to an implant devices constructed with
metallic and polymeric components. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. A device for treating bone, comprising:
an intramedullary nail having a rigid body including a
metallic core and a polymeric casing extending over at least a
target portion of the metallic core to which a locking element
extending into the bone is to be permanently bonded by melting
a portion of an outer surface of the locking element and the
polymeric casing, wherein the casing extends distally beyond a
distal end of the metallic core to define a non-metallic distal tip
having a tapered wall extending along a first side thereof so that
a thickness of the intramedullary nail tapers from a first thickness
at the distal end of the metallic core to a second reduced thickness
at a distal end of the distal tip of the nail,
wherein the locking element is formed as a locking tack
with a shaft and a head having a diameter greater than that of the
shaft, and
wherein the distal end of the locking tack includes at least
two angled faces extending from a distal tip on the shaft of the
locking tack toward the head of the locking tack to increase the
outer surface area of the locking tack and form a concave relief
at the distal tip and a protruding portion in the concave relief at
a junction of the at least two angled faces.
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Application 12/524,427
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Aeschlimann ’6662 US 6,913,666 B1
Aeschlimann ’3413 US 2004/0030341 A1
Bramlet US 2004/0193162 A1
Rousseau US 2005/0240189 A1
Schlienger US 2006/0149248 A1
Bonutti US 2007/0270833 A1
July 5, 2005
Feb. 12, 2004
Sept. 30, 2004
Oct. 27, 2005
July 6, 2006
Nov. 22, 2007
REJECTIONS4
(I) Claims 1, 12, 14—20, 27, 28, and 32 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Bonutti, Aeschlimann ’341, and
Aeschlimann ’666.
(II) Claim 13 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Bonutti, Aeschlimann ’341, Aeschlimann ’666, and Rousseau.
(III) Claims 21 and 23—25 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Bonutti.
(IV) Claim 22 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Bonutti and Schlienger.
2 Appellants and the Examiner refer to this reference as “Aeschlimann2.”
See, e.g., Final Act. 3, Appeal Br. 5.
3 Appellants and the Examiner refer to this reference as “Aeschlimannl.”
See, e.g., Final Act. 3, Appeal Br. 5.
4 The Examiner withdrew rejections of claims 12 and 14 under 35 U.S.C.
§112, second paragraph, as indefinite, and a rejection of claims 11, 29-31,
and 39 under 35 U.S.C. § 103(a) as unpatentable over Bonutti,
Aeschlimann ’341, Aeschlimann ’666, and Bramlet. Adv. Act. 1; Ans. 22—
23.
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Application 12/524,427
(V) Claims 33—38 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Bonutti and Aeschlimann ’666.
OPINION
Rejection (I), claims 1, 12, 14—20, 27, 28, and 32
The Examiner finds that Figures 23C—23D of Bonutti disclose many
of the features recited in claim 1, but do not disclose a first locking element
with at least two angled faces as recited, and the Examiner relies on the
embodiment depicted in Figure 12E of Bonutti to remedy this deficiency.
Final Act. 3—4. The Examiner also finds that Bonutti is silent regarding a
casing extending distally beyond a distal end of a metallic core of the nail
and defining a non-metallic distal tip having a tapered wall. Final Act. 5.
Nonetheless, the Examiner finds that Aeschlimann ’341 teaches a
casing (57) extend[ing] over the core (63) to define a non-
metallic distal tip (tip made from only the thermoplastic casing)
having [a] tapered wall extending along a first side thereof so that
a thickness of the intramedullary nail tapers from a first thickness
at the distal end of the metallic core to a second reduced thickness
at a distal end of the distal tip.
Final Act. 5. The Examiner provides an annotated copy of Figure 28 of
Aeschlimann ’341 indicating where the Examiner finds the non-metallic tip
(Final Act. 6), which we reproduce below.
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Application 12/524,427
The Examiner’s annotated copy of Figure 28 of Aeschlimann ’341 depicts
tubular bone 50 in which stem 63 of implant 7 is located. Final Act. 5;
Aeschlimann ’34197—98. The annotated copy of Figure 28 also includes
a detail view of the distal tip of the implant 7 indicating where the Examiner
finds an area of reduced thickness. The Examiner reasons that it would have
been obvious to modify Bonutti to include a tapered tip as disclosed by
Aeschlimann ’341 to provide easier insertion. Final Act. 7.
Appellants argue that Aeschlimann ’341 does not disclose that its
casing extends distally beyond the end of the stem. Appeal Br. 6. In this
regard, Appellants assert that Figure 28 of Aeschlimann ’341 shows the state
of the casing only after it has been melted, and Figure 28 does not indicate
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the shape of the casing before it is melted. Appeal Br. 6. Appellants assert
that the text of Aeschlimann ’341 does not support the Examiner’s finding
that the casing is tapered. Appeal Br. 6—7. Appellants also argue that
“Aeschlimann[ ’341] never once states that the casing is uniform around the
stem 63, only that there is a ‘positive fit connection’ to the stem,” the casing
in Aeschlimann ’341 appears thicker at its proximal end than at its distal
end, and “no conclusion about uniformity can be drawn from [Figure 28]
alone.” Appeal Br. 7.
In response, the Examiner reiterates that Figure 28 of
Aeschlimann ’341 may be relied upon for the above-noted feature, and the
Examiner states, “there are no limitations in the claims towards a melted
state vs. a non-melted state of the coating. Figure 28 of Aeschlimann[ ’341]
clearly shows the casing following the contours of the tapering metal core
resulting in a tapered non-metallic distal tip.” Ans. 27.
In reply, Appellants assert Aeschlimann ’341 “fails to disclose or
suggest that this coating tapers from a first thickness to a second thickness as
it extends distally beyond the distal end of the titanium stem to define a non-
metallic distal tip. Rather, the reference states only that the coating is
arranged around the stem.” Reply Br. 4 (emphasis added). Appellants
further argue, “at no point does Aeschlimann[ ’341] teach or suggest that the
casing of the intramedullary nail extends distally beyond the distal end of
the titanium stem, much less that the casing extending distally beyond a
distal end of the titanium stem in a tapered fashion” and “because the casing
is subsequently melted once the intramedullary nail is inserted into the bone,
the external shape of the casing as it extends beyond the distal tip would
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Application 12/524,427
have little importance and thus, no conclusion about distal end of the casing
can be drawn.” Reply Br. 4—5.
Additionally, in the Reply Brief, Appellants argue,
there is no support anywhere in the Specification or Drawings of
Aeschlimann[ ’341] for the Examiner’s argument that a tapered
shape of the tip of the casing would be more beneficial than a flat
shaped tip because once the intramedullary nail is inserted into
the tubular bone, the casing is liquefied to press into the pores of
the surrounding cancellous bone.
Reply Br. 4 (emphasis added). Appellants also reassert that “one of ordinary
skill in the art would not reasonably ascertain from Fig. 28 that the casing is
applied in a uniform manner around the stem so that it tapers to a distal tip
because Fig. 28 shows a non-uniform casing” and that Aeschlimann ’341
does not disclose that its drawings are to scale. Reply Br. 5—6.
We do not agree with Appellants’ arguments. We reproduce Figure
28 of Aeschlimann ’341 below.
Figure 28 of Aeschlimann ’341 depicts tubular bone 50 in which
artificial joint element 62 is attached via stem 63 of implant 7 surrounded by
liquefiable material 57. Aeschlimann ’34197—98.
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The end of implant 7 is depicted as covered by material 57, which the
Examiner finds corresponds to a casing as recited in claim 1 (Final Act. 5).
Although Figure 28 is a cross-section of the arrangement of implant 7,
tubular bone 50, and material 57; paragraph 98 of Aeschlimann ’341
indicates that stem 63 may be surrounded by liquefiable material, i.e., by
material 57. Thus, a person of ordinary skill in the art would understand that
material 57 extends around stem 63. See Reply Br. 4 (“Aeschlimann[ ’341]
discloses an intramedullary implant having a titanium stem with a
liquefiable coating around the stem.”). Because material 57 extends around
stem 63, it also extends beyond stem 63. This is explicitly depicted in
Figure 28 where material 57 extends farther to the left in the drawing than
stem 63 extends. See Final Act. 6, annotated Figure 28.
With respect to Appellants’ argument that Figure 28 depicts material
57 only after melting (Appeal Br. 6), whether the arrangement depicted in
Figure 28 is before or after melting and solidification, material 57 satisfies
the requirement in claim 1 for a
casing extend[ing] distally beyond a distal end of the metallic
core to define a non-metallic distal tip having a tapered wall
extending along a first side thereof so that a thickness of the
intramedullary nail tapers from a first thickness at the distal end
of the metallic core to a second reduced thickness at a distal end
of the distal tip of the nail.
In this regard, claim 1 does not limit the shape of the casing such that this
shape must be present without there having been any melting.
As for Appellants’ allegation that Aeschlimann ’341 “fails to disclose
or suggest that this coating tapers from a first thickness to a second
thickness” (Reply Br. 4), we note that claim 1 requires the thickness of the
intramedullary nail to taper in this manner, not that the coating/casing do so
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independently of the nail. Thus, Appellants’ argument on this point is not
commensurate with the scope of claim 1.
Similarly, regarding Appellants’ contention that Aeschlimann ’341
fails to disclose a casing that is uniform and the casing in Aeschlimann ’341
“appears thicker at its proximal end than at its distal end” (Appeal Br. 7),
claim 1 recites no limitations as to the uniformity of the casing. In other
words, the taper required by claim 1 may be present even if the thickness of
material 57 is not uniform, and Figure 28 of Aeschlimann ’341 depicts the
structure at issue, regardless of any alleged variation in thickness of material
57.
As for Appellants’ argument that there is no support in
Aeschlimann ’341 that a tapered tip would be beneficial because it is not
disclosed as tapered before melting (Reply Br. 4—5), this assertion is
unpersuasive. The Examiner’s reasoning is supported by rational
underpinnings inasmuch as a tapered tip would allow easier insertion of a
device as implemented in the Examiner’s proposed combination of Bonutti
and Aeschlimann ’341. Appellants do not contest that a tapered tip would
allow easier insertion. To the extent that Appellants insist upon an explicit
motivation in the prior art to establish obviousness, the Supreme Court has
stated that a rigid insistence on teaching, suggestion, or motivation is
incompatible with its precedent concerning obviousness. KSR Int'l Co. v.
Teleflex Inc., 550 U.S. 398, 419 (2007). The Court noted that an
obviousness analysis “need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for [an examiner] can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” Id. at 418. Instead, the relevant inquiry is whether
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the Examiner has set forth “some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.” In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR, 550 U.S. at
418. Thus, Appellants’ contention that “[Aeschlimann ’341] provides no
indication that a tapered distal tip of the casing would be beneficial over a
flat shaped distal tip” (Reply Br. 5) is unavailing.
We have considered all of Appellants’ arguments for the patentability
of claim 1, but the Examiner has the better position. Accordingly, we affirm
the Examiner’s rejection of claim 1 as unpatentable over Bonutti,
Aeschlimann ’341, and Aeschlimann ’666. Appellants rely on the same
arguments for the patentability of independent claim 12 (Appeal Br. 8—9),
and for the same reasons discussed regarding the rejection of claim 1, we
affirm the rejection of claim 12 as unpatentable over Bonutti,
Aeschlimann ’341, and Aeschlimann ’666. Appellants make no additional
arguments for claims 14—20, 27, 28, and 32 (Appeal Br. 8—9), all of which
depend from either claim 1 or claim 12, and these claims fall with claims 1
and 12.
Rejection (II), claim 13
Appellants do not make additional arguments for the patentability of
claim 13 (Appeal Br. 9), and this claim falls with respective independent
claim 12.
Rejection (III), claims 21 and 23—25
Claim 21 recites, in part:
situating a bone plate over a first target portion of a bone,
the bone plate formed of a rigid metallic body having a first
opening formed therethrough, the first opening housing a
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polymeric portion therethrough, a diameter of the first opening
tapering from a first diameter at a non-bone contacting side of
the bone plate to a second diameter at a central portion of the
bone plate, the first diameter being greater than the second
diameter;
inserting a first locking element at any of a plurality of
angles through the polymeric portion and into a first locking
element receiving bore formed in the first target portion of the
bone.
Appeal Br. 20 (Claims App.).
The Examiner relies on Figures 25 A—25B of Bonutti to teach many of
the features in claim 21, but relies on Figures 27 A—27C to teach the recited
limitations relating to the first and second diameters of the opening in the
rigid metallic body. Final Act. 21—22. The Examiner reasons that it would
have been obvious “to modify the opening of the bone plate of the
embodiment of Fig. 25A-B with the tapered opening of Fig. 27C in order to
accommodate a smooth spherical headed fastener thus providing a surface
best conforming to said fastener in order to best bond the two components
together.” Final Act. 22. Regarding the “inserting” process recited in claim
21, the Examiner finds:
The first locking element or fastener (432) can be inserted
initially {the tip of the fastener can be inserted) at any angle (any
of a variety of angles as is evidenced in the modified figure
below), as the tip of the fastener is smaller in diameter than the
first diameter of the opening in the bone plate (the tip of the
fastener has a smaller diameter than the head of the fastener), and
the shape of the opening in conjunction with the shape of the
fastener will align the fastener as it moves through the length of
the opening and into the bone.
Final Act. 22 (emphasis added). Further, in the Advisory Action, the
Examiner finds that
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a perpendicular angle to the bone (inserting the locking element
at 90 degrees relative to the longitudinal axis of the bone and/or
plate) satisfies the claim limitation of “inserting a first locking
element at any of a plurality of angles” as 90 degrees is an angle
within any of a plurality of angles.
Adv. Act. 2.
Appellants assert that only the tip of the fastener in Bonutti can be
inserted into the opening in the opening of the bone plate in Bonutti, and this
fails to satisfy the requirement in claim 21 for inserting a first locking
element at any of a plurality of angles. Appeal Br. 12. Appellants also
argue that claim 21 requires more than the ability to insert the locking
element at only a single angle such as at an angle of 90 degrees. Appeal Br.
12-13.
In response, the Examiner reiterates that claim 21 does not require
more than the tip of the locking element to be inserted. Ans. 28.
Additionally, the Examiner states:
the language of “at any of a plurality of angles” is a limitation
that reads on a single angle — a single angle selected from a
plurality, in other words, Examiner is interpreting this limitation
as ‘at least one of a plurality of angles’. Appellant’s argument
that this limitation requires more than just one angle does not
correspond with the claim language.
Ans. 29.
In reply, Appellants argue that inserting only the tip of the fastening
element into the plate does not position the fastening element into the target
portion of a bone as recited. Reply Br. 9—10. As for how the fastening
element is inserted, Appellants contend, “The first locking element,
according to the claim language, must be able to be inserted at any of a
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plurality of angles. That is, more than just one angle relative to the
longitudinal axis of the bone.” Reply Br. 10.
We do not agree with Appellants’ interpretation of claim 21 as
requiring the ability to insert at more than one angle. Appellants’ argument
relies on providing a structure capable of receiving a fastening element at
any of a plurality of angles, whereas the broadest reasonable interpretation
of method claim 21 requires only one insertion action, which is performed at
only one angle. In other words, claim 21 does not require multiple insertion
steps, each performed at a different angle, and claim 21 does not require
providing structure capable of such steps. Rather, claim 21 recites, in
pertinent part, “inserting a first locking element at any of a plurality of
angles through the polymeric portion and into a first locking element
receiving bore formed in the first target portion of the bone.” Appeal Br. 20
(Claims App.). Thus, inserting the fastening element, at a single angle and
into the bone as the Examiner finds is disclosed by Bonutti, satisfies the
limitation in claim 21 argued by Appellants. See Ans. 29 (“the first locking
element of Bonutti being inserted entirely through the plate and entirely into
the bone at 90 degrees relative to the longitudinal axis of the bone and/or
plate satisfies the claim limitation.”). Accordingly, we affirm the
Examiner’s rejection of claim 21 as unpatentable over Bonutti. Appellants
make no additional arguments for claims 23—25 (Appeal Br. 13), and these
claims fall with claim 21, from which they depend.
Rejection (IV), claim 22
Appellants make no additional arguments for the patentability of
claim 22, which depends from claim 21. Appeal Br. 14—15. Accordingly,
claim 22 falls with claim 21.
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Rejection (V), claims 33—38
Appellants make the same arguments for the patentability of claim 33
as those discussed above for claim 21. Appeal Br. 14. Accordingly, we
affirm the Examiner’s rejection of claim 33 for the reasons discussed above.
Additionally, we note that claim 33 does not recite any limitation
corresponding to the above-noted “inserting” step recited in claim 21.
Appellants make no additional arguments for claims 34—38 (Appeal Br. 14),
and these claims fall with claim 33, from which they depend.
DECISION
The Examiner’s decision to reject claims 1, 12—25, 27, 28, and 32—38
is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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