Ex Parte Mackay

Patent Trials and Appeals Board

Jan 25, 2019

13455581 - (D) (P.T.A.B. Jan. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/455,581 04/25/2012
26096 7590 01/29/2019
CARLSON, GASKEY & OLDS, P.C.
400 WEST MAPLE ROAD
SUITE 350
BIRMINGHAM, MI 48009
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Gordon M. Mackay
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
67145-482 PUSl 5138
EXAMINER
DIOP, ROKHAYA
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
01/29/2019 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):
ptodocket@cgolaw.com
cgolaw@yahoo.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GORDON M. MACKA Y 1
Appeal 2017-011449
Application 13/455,581
Technology Center 3700
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and JOHN E.
SCHNEIDER, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to methods of surgical repair.
The Examiner rejected the claims as anticipated under 35 U.S.C. § 102 and
as obvious under 35 U.S.C. § 103. Pursuant to 35 U.S.C. § 134, Appellant
appeals the Examiner's determination that the claims are unpatentable. We
have jurisdiction under 35 U.S.C. § 6(b ). We affirm the Examiner's
decision.
STATEMENT OF THE CASE
The claims stand finally rejected by the Examiner as follows:
1 The Appeal Brief ("Br."; entered Jan. 27, 2017) identifies Arthrex, Inc., as
the real party in interest.
Appeal 2017-011449
Application 13/455,581
1. Claims 45, 49, 51, 61 and 62 under pre-AIA 35 U.S.C. § I02(b) as
anticipated by Kdolsky et al., Journal of Orthopaedic Research, 1997, 15(1 ):
1-10 ("Kdolsky"). Ans. 3.
2. Claims 46-48, 50, and 52-54 under pre-AIA 35 U.S.C. § I03(a)
obvious in view ofKdolsky and Dreyfuss et al., US 2009/0222039 Al,
published Sept. 3, 2009 ("Dreyfuss"). Ans. 5.
3. Claims 55, 63, and 64 under pre-AIA 35 U.S.C. § I03(a) obvious
in view ofKdolsky and Hoof et al., US 2009/0198288 Al, published Aug. 6,
2009 ("Hoof'). Ans. 7.
4. Claims 56 and 57 under pre-AIA 35 U.S.C. § I03(a) obvious in
view ofKdolsky and Tobis et al., WO 2009/113076 Al, published Sept. 17,
2009 ("Tobis"). Ans. 8.
5. Claim 60 under pre-AIA 35 U.S.C. § I03(a) obvious in view of
Kdolsky and ACL Reconstruction with LARS Ligament Surgical Technique
(Brochure), 2009, distributed by Corin ("Corin"). Ans. 8.
Claim 45, the only independent claim on appeal, is reproduced below:
45. A method of surgical repair comprising
securing a reconstruction system adjacent to a repaired or
replacement ligament, wherein the reconstruction system is a
reinforcement construct secured by fixation devices,
wherein a first fixation device is secured adjacent to the
repaired or replacement ligament's anatomical origin point, and
a second fixation device is secured adjacent to the repaired or
replacement ligament's anatomical insertion point.
ANTICIPATION BY KDOLSKY
The Examiner found that Kdolsky describes all the steps of the
claimed surgical repair method. The Examiner found the Kdolsky describes
a braided polypropylene augmentation device which serves as the claimed
2
Appeal 2017-011449
Application 13/455,581
"reconstruction construct." Ans. 3, 4. The Examiner found that the braided
polypropylene augmentation device is attached "adjacent the autograft [the
claimed "repaired or replacement ligament"] or reattached ligament in the
bone tunnel." Id. at 3. The Examiner further found the braided
polypropylene augmentation device is attached at both ends by fixation
screws, meeting the limitation of claim 45 of being "secured by fixation
devices." Id.
Appellant argues that Kdolsky does not teach fixating the
reconstruction device with fixation devices as claimed. Appeal Br. 8.
Appellant also contends there is no disclosure in Kdolsky of securing the
augmentation device adjacent to the ligament's anatomical origin point or
insertion point. Id. at 6. Appellant states:
Id.
The anatomical origin point of the ACL is located at the
posteromedial comer of the medial aspect of the lateral femoral
condyle in the intercondylar notch, and the anatomical insertion
point of the ACL is located at the fossa in front of and lateral to
the anterior spine of the tibia.
In contrast, Appellant argues that the augmentation device (i.e., the
"reinforcement construct" of the rejected claims) in Kdolsky is fixated by
the over-the-top route which "passes the graft over the superomedial border
of the lateral femoral condyle so it can be fixated on the lateral femoral
shaft." Appeal Br. 7. Appellant also contends that the augmentation device
of Kdolsky is not adjacent to the composite graft. Id.
"reinforcement construct secured by fixation devices"
As found by the Examiner, Kdolsky describes a "braided
polypropylene ligament augmentation device" which serves as a
3
Appeal 2017-011449
Application 13/455,581
"reinforcement construct" as required by claim 45. The Examiner's finding
is supported by the following disclosure from Kdolsky:
FFl. 2
Between 1983 and 1992, 594 patients (255 female and 339
male; average age 28.3 years [range 16-49]) had reconstruction
of a ruptured anterior cruciate ligament performed with use of
the braided polypropylene ligament augmentation device
(Kennedy; 3M, St. Paul, MN, U.S.A.) with temporary, rigid
double-end fixation.
Kdolsky 2.
Kdolsky states that the reconstruction using the braided polypropylene
ligament augmentation device is performed "with double-end fixation,"
indicating first and second fixation devices, as required by the claim, are
used to "fix" the ligament augmentation device in position. In addition to
this, Kdolsky discloses:
FF2.
In contrast to the original procedure and to the manufacturer's
recommendations, rigid double-end fixation was used (8, 29).
Prior to fixation of the reattachment or the composite graft, the
ligament augmentation device was preloaded with 70-100 N,
according to 10% of the patient's body weight, with the knee
joint in extension. From 1983 to 1987, the fixation hardware was
"Burri-plates" (Hug, Freiburg, Germany); since 1988, cancellous
bone screws (6.5 mm diameter) with a washer (Mathys, Bettlach,
Switzerland) have been used.
Kdolsky 2 ( emphasis added).
Thus, Kdolsky again teaches double-end fixation for the augmentation
device. 3 Appellant's argument that "fixation devices", as recited in claim
2 Finding of Fact ("FF").
3 "Kdolsky discloses (page 2, column 2, lines 11-12) the use of rigid double
end fixation for the composite graft. Because the composite graft consists of
4
Appeal 2017-011449
Application 13/455,581
45, are not disclosed by Kdolsky does not address the disclosure in Kdolsky
(FFl, FF2) which refers to double end-fixation. Appeal Br. 8; Reply Br. 2.
Furthermore, while Appellant argues that the disclosure in FF2 indicates that
the screws are used to attach the composite graft, Appellants ignore the
disclosure of "double-end fixation" in FF 1 ("the braided polypropylene
ligament augmentation device . . . with temporary, rigid double-end
fixation."). Thus, even if the screws or plates are a reference to fixating the
graft, it does not undermine the explicit disclosure of double-end fixation in
Kdolsky for the augmentation device in FPL Thus, we find Appellant's
argument to be without adequate evidentiary basis.
"ligament's anatomical origin point"
Appellant contends that the over-the-top position utilized to attach the
braided polypropylene ligament augmentation device is not "adjacent" to the
graft's anatomical origin and insertion points as required by the claims and
therefore the claims cannot be anticipated. Appeal Br 7.
Kdolsky has the following pertinent teachings:
FF3.
The [ anterior cruciate] ligament was reattached using a modified
Marshall technique (multiple nonresorbable suture loops)
(17, 18) and augmented with the ligament augmentation device
by the over-the-top route.
Kdolsky 2.
FF4.
From 1983 to 1987, the proximal route of the augmentation
a replacement ligament and the ligament augmentation device, the ligament
augmentation device must be anchored to the bone by the rigid double end
fixation." Ans. 12.
5
Appeal 2017-011449
Application 13/455,581
device was with the graft through the same bone tunnel in the
femoral condyle (parallel augmentation route).
Kdolsky 2.
FF5.
Since 1987, the proximal routing for the augmentation device has
been over the top through the posterior capsule (divergent
augmentation route).
Kdolsky 2.
Based on Findings of Fact 3-5, there are two different proximal
positions to which the ligament augmentation device was attached: 1) over-
the-top (FF3, FF5); and 2) through a bone tunnel in the femoral condyle
(FF4). Ans. 4, 11; Final Act. 4. Appellant explained that the 1) over-the-top
position results in fixation is on the lateral femoral shaft. Appeal Br. 7. The
Examiner did not challenge Appellant's explanation.
With regard to the bone tunnel disclosure (FF4), Appellant contends
that the Examiner "appears to be confusing routing the augmentation device
into the joint with securing the augmentation device into place." Appeal Br.
7. We do not agree.
Kdolsky refers to "routing" through a tunnel in the femoral condyle
during the earlier time period in which the operations were performed and
then "routing" over the top in a subsequent later time period. FF4, FF5.
Appellant states that "the screws described at the cited section of Kdolsky
appear to be used to fixate the composite graft within the bone tunnels.
There is no prima facie evidence that the screws are also used to fixate the
ligament augmentation device." Appeal Br. 8 ( emphasis added). Yet,
Appellant also states: "The cited reference discloses an augmentation within
a bone tunnel. Thus, Kdolsky is teaching fixation from within bone." Reply
6
Appeal 2017-011449
Application 13/455,581
Br. 3. The "the augmentation device was with the graft." FF4. Because the
augmentation device is "with" the graft, it was reasonable for the Examiner
to believe that the device would be fixated at the same position as the graft, a
fact which appears to have been admitted in the Reply Brief.
In sum, the finding that Kdolsky disclose fixation of a reinforcement
construct at both the over-the-top and condyle tunnel locations is supported
by a preponderance of the evidence.
"secured adjacent to"
The next issue to address is whether these locations are "adjacent" to
the anatomical origin and insertion points as required by the claims. The
meaning of the claim term "adjacent" is in dispute.
During patent examination proceedings, claim terms are given "the
broadest reasonable meaning ... in their ordinary usage as they would be
understood by one of ordinary skill in the art, taking into account whatever
enlightenment by way of definitions or otherwise that may be afforded by
the written description contained in the applicant's specification." In re
Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
We first look to the specification for guidance on the meaning of
"adjacent" to the anatomical origin and insertion points. While the
Specification refers to these locations generally (Spec. ,r,r 30, 34), there is no
definition of the term "adjacent" and Appellant did not direct us to an
example in the Specification of a location that is "adjacent" to anatomical
origin and insertion points. Reply Br. 3. In the absence of such a definition,
the Examiner reasonably consulted a general purpose dictionary and
7
Appeal 2017-011449
Application 13/455,581
interpreted "adjacent" to mean in the "vicinity of' or "near something."4
Ans. 10. Appellant contends that the Examiner's interpretation is not the
broadest reasonable interpretation of the disputed phrase, but did not identify
a specific defect in the Examiner's interpretation nor provide their own
interpretation. Reply Br. 2-3.
Consequently, we agree with the Examiner that the term "adjacent"
means "nearby" and that the fixation devices must therefore be fixated
nearby the ligament's anatomical origin and insertion points.
The Examiner found that the over-the-top and bone tunnel locations
meet the claimed limitations of a fixation device "secured adjacent to the
repaired or replacement ligament's anatomical" origin point or insertion
point. Ans. 3--4, 11.
Appellant contends that the Examiner erred because "Anatomical
origin and insertion points do not occur within the bone but rather at the
interface between the ligament and the bone surface." Reply Br. 2
( emphasis added). This argument is not persuasive. The claim does not
recite that the fixation occurs "at" these points, but rather "adjacent" to
them.
Appellants also argue:
The interpretation that "within a few inches" is still "adjacent" to
the anatomical origin and insertion points is also not consistent
with the meaning that those of ordinary skill in the art would
reach. Persons of ordinary skill in the art in the field of surgery
would understand that a "few inches" is a rather large distance as
it relates to anatomy and performing surgical procedures. In this
4 la: not distant: NEARBY (https://www.merriam-
webster.com/dictionary/adjacent) (last accessed January 13, 2019)
8
Appeal 2017-011449
Application 13/455,581
case, a more reasonable interpretation of "adjacent to" would be
within a few millimeters rather than within a few inches.
Reply Br. 3.
However, Appellant has not established that the over-the-top5 and
bone tunnel locations are inches away from the insertion and origin points,
rather than millimeters away. And more importantly, Appellant has not
provided objective evidence as to why one of ordinary skill in the art would
have interpreted the term "adjacent" to exclude certain distances and not
others. Rather, Appellant has relied on unsupported attorney argument. An
argument made by counsel in a brief does not substitute for evidence lacking
in the record. Estee Lauder, Inc. v. L 'Orea!, S.A., 129 F.3d 588, 595 (Fed.
Cir. 1997).
Appellant also states that "the ligament augmentation device of
Kdolsky (i.e., the alleged reinforcement construct) is not secured 'adjacent'
to the composite graft (i.e., the alleged repaired or replacement graft)."
Appeal Br. 7.
"securing a reconstruction system adjacent to a repaired or replacement
ligament"
Claim 45 recites "securing a reconstruction system adjacent to a
repaired or replacement ligament." The system is "a reinforcement construct
secured by fixation devices." We interpret the claim to require that the
replacement construct, itself, to be "adjacent" to the ligament, or what
Appellant refers to as the "composite graft."
5 Appellant does not provide any guidance whatsoever where the "over-the-
top" location is on the knee in relation to the anatomical origin or insertion
point of the ligament.
9
Appeal 2017-011449
Application 13/455,581
Kdolsky teaches that the ligament was (1) "augmented with the
ligament augmentation device by the over-the-top route" (FF3) and that (2)
"the proximal route of the augmentation device was with the graft through
the same bone tunnel in the femoral condyle (parallel augmentation route)"
(FF4).
In the (2) bone tunnel embodiment, Kdolsky explicitly teaches that
device is "with" the graft (FF4), providing evidence that it is nearby and
therefore adjacent to it as the claim requires. Ans. 11. Appellant contends
"the augmentation device is not routed through any tunnel in the Kdolsky
method" (Appeal Br. 8), yet ignores the explicit disclosure in Kdolsky that
"the proximal route of the augmentation device was with the graft through
the same bone tunnel in the femoral condyle (parallel augmentation route)"
(emphasis added) (FF4).
In the (1) over-the-top route, Appellant contends:
The "over-the-top route" would not position the ligament
augmentation device "adjacent to" the composite graft. Instead,
as is known in the art, the over-the-top route passes the graft over
the superomedial border of the lateral femoral condyle so it can
be fixated on the lateral femoral shaft. These fixation locations
of the ligament augmentation device are not "adjacent" to the
composite graft, let alone adjacent to the anatomical origin or
insertion points.
Appeal Br. 7.
Appellant describes the graft position in Kdolsky as being passed over
the condyle, but does not describe the position of the augmentation device.
However, Kdolsky, in fact, discloses the position of the augmentation
device. Kdolsky teaches that "[ s ]ince 1987, the proximal routing for the
augmentation device has been over the top through the posterior capsule
( divergent augmentation route)." FF5. Thus, the path of the augmentation
10
Appeal 2017-011449
Application 13/455,581
device is the same over-the-top path as Appellant admits is the path of the
graft. Accordingly, it was reasonable for the Examine to conclude that
Kdolsky describes "a reconstruction system adjacent to a repaired or
replacement ligament" as required by the claim.
For the foregoing reasons, the anticipation rejection of claim 45 is
affirmed. Claims 49, 51, 61 and 62 were not argued separately and fall with
claim 45.
2. OBVIOUSNESS BASED ON KDOLSKY AND DREYFUSS
Claim 50
Claim 50 depends from claim 45, and further recites that the
reinforcement construct is a biological construct.
The Examiner found that Dreyfuss describes "the use of a biological
construct, which is fully capable of being used as a reinforcement construct
for surgical repair, in the same field of endeavor, for the purpose of
facilitating the healing of the original ligament after the operation." Final
Act. 6.
Appellant states that Kdolsky teaches away from the modification.
Appellant argues:
The entire purpose of Kdolsky was to study the long term clinical
performance of patients in whom a ruptured ACL was treated
using the braided polypropylene augmentation device. See pages
1-2. Therefore, replacing the braided polypropylene
augmentation device of Kdolsky with the biological construct of
Dreyfuss would defeat the entire purpose for which the Kdolsky
study was conducted in the first place. Thereby, a biological
construct would render the Kdolsky augmentation device
unsatisfactory for its intended purpose. The proposed
modification is therefore improper.
11
Appeal 2017-011449
Application 13/455,581
Appeal Br. 11.
Appellant's arguments is not persuasive. As found by the Examiner,
Dreyfuss teaches that surgical sutures and tapes can be made of biological
materials. Dreyfuss ,r,r 7-9, 16, 17. The Examiner's position is that it would
have been obvious to have used the biological construct in Dreyfuss in place
of the braided polypropylene augmentation device of Kdolsky. We agree.
As held in KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007):
[I]f 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.
... [A] court must ask whether the improvement is more than the
predictable use of prior art elements according to their
established functions.
Appellant did not provide evidence or adequate arguments as to why
the biological material in Dreyfuss would not work nor did Appellant
explain why it would not have been obvious to use it in place of Kdolsky's
augmentation device. Appellant appears to be arguing that because Kdolsky
was studying the performance of the braid, there would be no reason to
replace it. But the Examiner gave reasons as indicated above (Final Act 6,
Ans. 16). In addition, the Examiner stated:
Based on the teachings of Dreyfuss, one of ordinary skill would
have been motivated to replace the synthetic augmentation
device of Kdolsky, which is known to cause chronic
inflammation (see Kdolsky page 1, column 1 ), with a biological
construct in order to reduce the risks of inflammation and to
promote healing.
Ans. 16.
12
Appeal 2017-011449
Application 13/455,581
Thus, substituting the biological material of Dreyfuss in Kdolsky
would not change its principle of operation as stated by Appellant, but would
address a problem associated with it.
Claims 5 3 and 54
Claims 5 3 and 54 are argued by Appellant. The claims are
reproduced below:
53. The method of surgical repair of claim 49, wherein
the suture construct is a suture tape.
54. The method of surgical repair of claim 49, wherein
the suture construct is a collagen tape.
The Examiner found that "Dreyfuss teaches (figures 1-2; [0023]-
[0024]) the use of a surgical suture (100) formed from collagen, the collagen
is provided as a suture tape for the purpose of enhancing the wound healing
effect." Final Act. 7. The Examiner concluded it would have been obvious
to one having ordinary skill in the art, at the time the invention was made,
"to combine the braided polypropylene augmentation device of Kdolsky
with a collagen tape, as taught by Dreyfuss, in order to enhance the wound
healing effect. Id.
Appellant states that the Examiner's reasoning is conclusory. Appeal
Br. 12. We do not agree. The Examiner explained the collagen would
promote wound healing and further clarified that the augmentation device
can cause inflammation and that the collagen would reduce the risk of
inflammation and promote healing (Ans. 16). Thus, the Examiner provided
a logical and scientific basis for determination that the claims are obvious.
Appellant did not demonstrate an error in this reasoning and we find none.
13
Appeal 2017-011449
Application 13/455,581
The obviousness rejection of claims 50, 53, and 54 is affirmed.
Claims 46-48, and 52 fall with these claims because separate reasons for
their patentability were not provided. 37 C.F.R. § 4I.37(c)(iv).
OBVIOUSNESS REJECTION 3, 4, AND 5
Appellant makes the same arguments for obviousness rejections 3, 4,
and 5 (as numbered above) as they did for claim 45. Appeal Br. 12-17.
Thus, the rejections are affirmed for the same reasons.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
14