Ex Parte Contiliano et al

Patent Trial and Appeal Board

Dec 21, 2016

12777922 (P.T.A.B. Dec. 21, 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.
12/777,922 05/11/2010 Joseph H. Contiliano 47060-012D01US 5348
30623 7590 12/23/2016
Mintz Levin/Boston Office
One Financial Center
Boston, MA 02111
EXAMINER
DAVID, SHAUN L
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
12/23/2016 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):
IPDocketingBOS @ mintz.com
IPFileroombos @ mintz. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSEPH CONTILIANO, YUFU LI, and ZHIGANG LI
Appeal 2014-009816
Application 12/777,9221
Technology Center 3700
Before LINDA E. HORNER, JEREMY M. PLENZLER, and
JEFFREY A. STEPHENS, Administrative Patent Judges.
PLENZLER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134 of the Examiner’
Final Decision rejecting claims 1—3 under 35 U.S.C. § 103(a) as being
unpatentable overBorzone (US 5,814,070, iss. Sept. 29, 1998) and Stone
(US 7,713,285, iss. May 11, 2010). We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM-IN-PART and enter a NEW GROUND OF
REJECTION in accordance with 37 C.F.R. § 41.50(b).
1 Appellants identify Ethicon, Inc. as the real party in interest. App. Br. 1
Appeal 2014-009816
Application 12/777,922
CLAIMED SUBJECT MATTER
Claims 1 and 3 are independent, with claim 2 depending from claim 1.
Claims 1 and 3 are reproduced below.
1. A surgical method, comprising:
positioning an anti-rotational member that is monolithic with
a solid drive head of a medical fixation device within an opening
extending through a sidewall of a driver tool to attach said driver
tool to said medical fixation device, the anti-rotational member
being formed on and extending laterally from an outer surface of
the solid drive head such that the drive head is positioned within
a distal end of the driver tool when the anti-rotational member is
positioned in the opening in the sidewall of the driver tool;
inserting a shank extending distally from the drive head of the
medical fixation device through at least one tissue segment, the
shank having a thread that terminates distal of the solid drive
head; and
implanting the shank in bone to anchor a tissue segment in
bone.
3. A surgical method, comprising:
inserting a drive head of a medical fixation device into a distal
end of a driver tool such that the drive head is fully enclosed
within the distal end of the driver tool, wherein an anti-rotational
surface feature monolithic with the drive head and protruding
from an outer surface of the drive head extends through an
opening formed in a sidewall of the driver tool;
inserting a shank extending distally from the drive head of the
medical fixation device through at least one tissue segment, the
shank having a thread that terminates distal of the solid drive
head; and
implanting the shank in bone to anchor a tissue segment in
bone.
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Application 12/777,922
OPINION
New Ground of Rejection — Indefiniteness
Pursuant to our authority under 37 C.F.R. § 41.50(b), we reject claims
1—3 under 35 U.S.C. § 112,12 as being indefinite.
As seen above, claims 1 and 3 each recite “implanting the shank in
bone to anchor a tissue segment in bone.” This limitation is unclear. For
example, it is unclear as to whether “a tissue segment” may include bone
tissue or is intended to be limited to some other tissue (i.e., whether the
bone, itself, is being anchored or whether something else is being anchored
to the bone). Furthermore, it is unclear what it means to “anchor [the] tissue
segment in bone’’ (e.g., whether this imitation requires that the tissue
segment is somehow anchored inside of a bone cavity). We find little
guidance in the Specification for determining the meaning of these
limitations.
The Specification explains, for example, that “[a] fixation device may
be used to directly secure tissue in close approximation to neighboring tissue
to effect healing such as is the case with meniscal fixation devices, or
fracture fixation pins, screws, or wires.” Spec. 13. Paragraph 43 of the
Specification similarly notes that “[t]he fixation devices disclosed herein
may be used in different ways to assist in the reconstruction of damaged
body tissue” and “may be used to directly secure tissue in close
approximation to neighboring tissue to effect healing.” Although the
fracture fixation devices described in these passages would be capable of
fixing bone to bone, neither of these passages describes such fixation as
“anchoring]” bone tissue “in bone.” The only discussion we see related to
“in bone” is also found at paragraph 43, which explains that the fixation
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Application 12/777,922
devices “may provide mechanical stability and load sharing during the
healing process, as when a graft is secured in a bone tunnel for ACL
reconstruction.” Paragraph 43 thus suggests that the claim phrase “anchor a
tissue segment in bone” would include securing tissue within bone, but it is
unclear from the claims and Specification whether a fixation device that only
indirectly secures tissue to bone would “anchor” the tissue “in bone” as
claimed.
Claim 3 additionally recites that “a drive head of a medical fixation
device ... is fully enclosed within the distal end of the driver tool, wherein
an anti-rotational surface feature monolithic with the drive head and
protruding from an outer surface of the drive head extends through an
opening formed in a sidewall of the driver tool.” It is unclear how a
structure monolithic with the drive head “extends through an opening
formed in . . . the driver tool,” while that drive head “is fully enclosed within
the distal end of the driver tool.” The Specification adds to the confusion,
rather than providing further clarification of this limitation. See, e.g., Spec.
123 (explaining that the drive head includes the anti-rotational member).
For these reasons, we enter a new ground of rejection under 35 U.S.C
§ 112,12 because those claims are indefinite. In re Packard, 751 F.3d
1307, 1311 (Fed. Cir. 2014) (affirming Board’s conclusion, in context of ex
parte appeal, that claims were indefinite “on grounds that they ‘contain[]
words or phrases whose meaning is unclear.’”).
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Appeal 2014-009816
Application 12/777,922
Claims 1 and 2
Examiner’s Rejection
Although we determine that claims 1 and 2 are indefinite, we are still
able to determine that we cannot sustain the Examiner’s rejection of those
claims.
Claim 1 recites that the medical fixation device has “a solid drive
head,” and the Examiner cites both Borzone and Stone as teaching that
limitation. Final Act. 3,5.
In order to determine whether Borzone or Stone teaches a “solid drive
head,” we first construe that term. The Examiner does not provide an
express construction of this term in the Final Action. Based on the rejection,
however, the Examiner appears to construe that term as requiring only that
some portion of the drive head is solid (i.e., other portions of the drive head
may have apertures extending therethrough). This is evident from the
annotated versions of Borzone’s Figure 4 and Stone’s Figure 14 on pages 4
and 5, respectively, of the Final Action. Appellants respond that
a “drive head” would not be interpreted in light of the present
specification by a person of ordinary skill in the art in the way
proposed by the Examiner, namely that some random part of an
anchor’s drive head is the drive head while other parts of the
anchor’s drive head are not the drive head.
App. Br. 8—9. Rather, Appellants contend that the drive head “is the entirety
of the structure at the proximal end of the member.” Id. at 9. We accept
Appellants’ construction of “drive head” as the entirety of the structure at
the proximal end of the member, with the clarification that the “drive head”
is the entire portion extending outward from the threaded shank and used to
rotate the shank. Furthermore, we determine that “solid” requires the
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Application 12/777,922
absence of apertures in the drive head.2 Without such a construction, the
term “solid” would be superfluous.
Under that construction, both Borzone and Stone fail to teach a “solid
drive head,” as the drive heads relied on by the Examiner in both references
have apertures. Accordingly, we do not sustain the Examiner’s rejection of
claims 1 and 2.
New Ground of Rejection
Nevertheless, we determine that it would have been obvious to use a
fixation device having a solid drive head in combination with the method
taught by Borzone and enter a new ground of rejection as to claims 1 and 2
based on unpatentability over Borzone, Stone, and Garcia (US 7,846,167,
iss. Dec. 7, 2010). We adopt the rejection of claims 1 and 2 in the Final
Action with the further modification that it would have been obvious to have
a solid drive head on the fixation device based on the teachings of Garcia.
Specifically, we find that Garcia teaches medical fasteners having solid drive
heads. See Garcia, 4:46-47 (“The head 16, post 18 and shank 20 may be
formed as a single piece from a desired material.”). We determine that it
would have been obvious to one skilled in the art at the time of the invention
to have further modified the combined teachings of Borzone and Stone
2 The Examiner proposes an alternate construction for “solid” in the
Answer, asserting that “[o]ne reasonable interpretation of the term ‘solid
drive head’, in light of the specification, is that the drive head is made from a
solid material - in other words not from a liquid or a gas.” Ans. 6—7. The
Examiner, however, fails to identify anything in the Specification that
supports that construction. See id. at 7 (noting that all examples disclosed in
the specification are solids). In any event, we determine that the Examiner’s
construction regarding “solid” denoting the state of matter is unreasonable.
Indeed, we are unaware of any manner in which a drive head could be a
liquid or a gas as suggested by the Examiner.
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Application 12/777,922
discussed in the Final Action to use a fixation device having a solid drive
head as taught by Garcia in procedures such as those not requiring apertures
for sutures. For example, such an arrangement (i.e., using a solid drive head
when apertures are not needed) would result in fixation devices that are
easier to manufacture and, accordingly, lower cost. Moreover, there appears
to be only two possible options for drive heads in this respect, they are either
solid or are not solid. Accordingly, we also determine that choosing whether
to use a solid drive head (i.e., one of two possible options) is nothing more
than design choice based on the application (e.g., whether or not apertures
are needed for sutures).
Appellants provide additional arguments directed to the Final Action’s
rejection of claims 1 and 2. App. Br. 5—6, 12—16. Although we did not
reach those arguments above in view of the Examiner error related to the
“solid” drive head feature, we address those arguments here, as they are
relevant to our new ground of rejection.
Appellants contend that Borzone and Stone each fail to teach an “anti-
rotational member” as required by claim 1. Id. at 12—14. The rejection cites
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Appeal 2014-009816
Application 12/777,922
Stone as teaching this feature and provides annotated versions of Stone’s
Figures 13 and 14. Final Act. 5.
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The annotated versions of Figures 13 and 14 from Stone are side and top
views, respectively, of Stone’s suture anchors annotated by the Examiner to
indicate the portions considered the anti-rotational members.
Appellants contend that “the portion of Stone’s suture engaging
portion 304 pointed to by the Examiner as being an ARM [(anti-rotational
member)] is actually part of the drive head—it is not a member that is formed
on and extends laterally from the solid drive head.” App. Br. 12. Appellants
reason that “the drive head cannot be formed on and extend laterally from
itself.” Id. at 12—13. This argument is unpersuasive because it is the exact
situation disclosed in the Specification of the pending application.3 See
Spec. 123 (explaining that the drive head includes the anti-rotational
member). Indeed, we see no example in the Specification of the pending
application where the anti-rotational member is not described as being part
3 This is part of the confusion regarding claim 3, which resulted in the
indefiniteness rejection discussed above.
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Appeal 2014-009816
Application 12/777,922
of the drive head. Accordingly, such an arrangement (i.e., an anti-rotational
member that is part of the drive head) is clearly within the scope of claim 1.
Appellants contend that even if Stone teaches the “anti-rotational
member,” it fails to teach the engagement between the “drive head” and the
“driver tool.” App. Br. 13—14. That argument, too, is unpersuasive. The
Examiner provides an annotated version of Stone’s Figure 17, reproduced
below, which illustrates the engagement between Stone’s driver tool and
fixation device. Final Act. 6.
The annotated figure is a fragmentary view of Stone’s Figure 17, which
illustrates Stone’s driver tool and fixation device in use, and includes
annotations from the Examiner indicating the portions considered the driver
tool, the openings in the sidewall of the driver tool, and the fixation device.
Appellants’ contentions alleging error in the rejection because of the
combination proposed are also unpersuasive. See App. Br. 5—6. The
positioning step is taught by the arrangement in Figure 17 of Stone discussed
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Appeal 2014-009816
Application 12/777,922
above, and the modification based on Garcia includes the “solid drive head”
feature. Stone additionally teaches the “inserting” and “implanting” steps.
See Stone, 10:24—39. To the extent Stone fails to disclose explicitly any
feature of the “inserting” or “implanting” steps, there appears to be no
dispute that Borzone explicitly discloses inserting and implanting a fastener
as required by these steps. For example, the rejection cites column 2, lines
23 to 25 of Borzone as teaching these features, and Appellants do not
dispute that finding. Final Act. 3. The cited portion of Borzone explains
that “[a] tissue protector tube is also provided to fit over the anchor and
driver device to help with the initial insertion of the device through soft
tissue and to engage the bone surface.” Borzone, 2:23—25. Moreover, the
method steps of “inserting” and “implanting” appear to be nothing more than
the conventional use of the medical fasteners recited in each of the
references. See App. Br. 5—6. Using a fastener and driver based on the
combined teachings of Borzone, Stone, and Garcia, in the manner described
in Borzone, would have been obvious to one skilled in the art, as it is the
conventional use of those components. Indeed, Appellants do not appear to
allege that any novelty lies in the conventional steps of “inserting” and
“implanting.”
Claim 2 depends from claim 1 and further recites that “an elongate
shaft of the driver tool has a maximum outer diameter not greater than a
major diameter of the shank.” We adopt the Examiner’s finding that Stone
teaches this limitation. See Ans. 15—16 (“Stone’s Fig. 17 shows a cross
section of the tool with the fixation device connected to the distal end” with
“the diameter of the shank, defined by the threads, as larger than the
diameter of the [driver tool] shaft.”). We note that Appellants did not
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Appeal 2014-009816
Application 12/777,922
dispute this finding, but contend that Stone fails to teach this limitation
because “the tool 360 surrounds the suture engaging section 304, thereby
necessarily having a maximum outer diameter opposite to that recited in the
claim.”4 App. Br. 16. Appellants appear to read the claim as requiring a
distal end of the tool (i.e., a part that engages a fastener drive head)
“ha[ving] a maximum outer diameter not greater than a major diameter of
the shank.” The claim however, has no such requirement, and simply
requires “an elongate shaft of the driver” meet the dimensional limitation
recited in the claim.
Claim 3
Although we determine that claim 3 is indefinite, we are still able to
determine that Appellants have failed to establish error in the Examiner’s
rejection of that claim.
The Examiner again cites the combination of Borzone and Stone in
the rejection of claim 3 and proposes combining their teachings to arrive at
the claimed method. Final Act. 3—6. In connection with claim 3, the
Examiner asserts that “Stone discloses a surgical method (see abstract)
comprising a medical fixation device and a driver tool for inserting the
medical fixation device into bone” with the fixation device’s drive head
“fully enclosed within the distal end of the driver tool” and “an anti-
rotational surface feature monolithic with the drive head and protruding
4 We note that the reference numerals depicted in Stone’s Figure 17 do not
necessarily correspond to those used in the corresponding description. For
example, although Stone refers to “tool 360,” that tool appears to be labeled
as “400” in Figure 17. See Stone, 9:67, Fig. 17.
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Appeal 2014-009816
Application 12/777,922
from an outer surface of the drive head extend [ing] through an opening
formed in a sidewall of the driver tool.” Id. at 5.
Appellants contend that “the rejection of claim 3 is improper because
it relies on a complete elimination of Borzone’s apparatus (anchor 10 and
driver 12) so as to completely redesign and reconstruct Borzone and/or
because it is entirely unclear what the Examiner’s proposed modification of
Borzone actually is.” App. Br. 17. We understand the Examiner’s rejection
as relying on Borzone primarily for an explicit teaching of the “inserting”
and “implanting” steps. See Final Act. 3. Appellants do not identify, or
even allege, error in those findings. As summarized above, the rejection
cites Stone as teaching the remaining limitations of the claim. We also are
not apprised of error in the Examiner’s proposal to use Stone’s driver tool
and fixation device in the manner taught by Borzone, which appears to be
nothing more than the conventional use of Stone’s driver tool and fixation
device.
Appellants further contend that “similar to that discussed . . . with
respect to claim 1, the Examiner’s interpretation of Stone’s drive head is not
reasonable since it necessarily strips meaning from the term ‘drive head’ in
the claim.” App. Br. 17. That argument is related to Appellants’ further
argument regarding the alleged failure of Borzone or Stone teaching anti-
rotational members. See id. The argument focuses on the confusion
surrounding claim 3 that, in part, led us to determine the claim is indefinite.
Specifically, claim 3 recites that “the drive head is fully enclosed within the
distal end of the driver tool,” but further requires that “an anti-rotational
surface feature monolithic with the drive head and protruding from an outer
surface of the drive head extends through an opening formed in a sidewall of
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Application 12/777,922
the driver tool.” Appellants contend that “the portion of Stone’s suture
engaging portion 304 pointed to by the Examiner as being an ARM is
actually part of the drive head” and “[t]he drive head cannot protrude from
an outer surface of itself.” Id. at 18. This argument is unpersuasive because,
as noted above, it is the exact situation disclosed in the Specification of the
pending application. See Spec. 123 (explaining that the drive head includes
the anti-rotational member).
Appellants additionally contend that “the alleged ARM of Stone
identified by the Examiner does not extend through an opening formed in a
sidewall of a driver tool since it is disposed within a cannulated interior
thereof.” App. Br. 18. In response, the Examiner provides an annotated
version of Stone’s Figure 13, reproduced below, illustrating the Examiner’s
understanding of the engagement between Stone’s driver tool and fixation
device. Ans. 14.
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Application 12/777,922
The annotated version of Stone’s Figure 13 is a side view of Stone’s suture
anchor with the addition of the driver tool schematically drawn by the
Examiner. Appellants fail to apprise us of error in this finding. See Reply
Br. 5—7 (presenting arguments as to whether the anti-rotational member can
be part of the drive head).
We note Appellants’ further contention regarding the arguably
disparate interpretations of what is considered the “drive head” in the
Examiner’s rejection of claims 1 and 3 (i.e., the characterization of Stone’s
drive head to meet claim 1 ’s “solid” limitation compared to claim 3’s “fully
enclosed” limitation). See Reply Br. 6—7 (“The Examiner cannot have it
both ways, with the ARM as alleged on page 5 of the Office Action
extending laterally as required by one part of the claim and with the totally
different ARM alleged on page 14 of the Examiner’s Answer being
positioned within an opening as required by another part of the claim.”). As
noted above, we agree with that observation, as evident by our reversal of
the Examiner’s rejection of claim 1. That observation, however, does not
apprise us of further error in the Examiner’s rejection of claim 3.
For the reasons noted above, we are not apprised of error in the
rejection of claim 3.
DECISION
We REVERSE the Examiner’s decision to reject claims 1 and 2;
We AFFIRM the Examiner’s decision to reject claim 3;
We enter a NEW GROUND OF REJECTION of claims 1-3 on the
basis that those claims are indefinite under 35 U.S.C. § 112,12; and
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Application 12/777,922
We also enter a NEW GROUND OF REJECTION of claims 1 and 2
on the basis that these claims are unpatentable under 35 U.S.C. § 103.
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.” 37 C.F.R. § 41.50(b) also provides that Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected, or both,
and have the matter reconsidered by the examiner, in which event the
proceeding will be remanded to the examiner . . .
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record . . .
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure §1214.01.
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-IN-PART; 37 C.F.R, § 41.50(b)
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