Ex Parte Rane

Patent Trial and Appeal Board

Jan 29, 2019

14041774 (P.T.A.B. Jan. 29, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/041,774 09/30/2013
19487 7590 01/31/2019
AMS/Kagan Binder, PLLC
221 Main Street North, Suite 200
Stillwater, MN 55082
FIRST NAMED INVENTOR
Ajay Rane
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.
AMS0129/US/2 5490
EXAMINER
COX, THADDEUS B
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
01/31/2019 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):
docketing@kaganbinder.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AJAY RANE
Appeal2017-011832 1
Application 14/041,774
Technology Center 3700
Before MURRIEL E. CRAWFORD, MICHAEL W. KIM, and
PHILIP J. HOFFMANN, Administrative Patent Judges.
CRAWFORD, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is an appeal from the final rejection of claims 14, 15, 18, 20-24,
and 26-28. We have jurisdiction to review the case under 35 U.S.C. §§ 134
and 6.
1 The Appellant identifies Endo Pharmaceuticals, Inc. as the real party in
interest. Appeal Br. 3.
Appeal2017-011832
Application 14/041, 77 4
The invention relates generally to surgical implants, insertion tools,
kits, and assemblies for treating pelvic floor disorders related to levator
avulsion. Spec. 4 lines 26-28.
Claim 14, the only independent claim on appeal, is illustrative:
14. A kit for treating a levator avulsion in a patient, the kit
compnsmg:
a first elongate implant comprising
a support portion comprising an anterior end, a
posterior end, a length extending between the anterior end
and the posterior end, and a width, the length being greater
than the width,
a first end portion extending from the support
portion, the first end portion having a proximal end
connected to the anterior end of the support portion, and a
distal end, a connector being attached to the distal end,
a second end portion extending from the support
portion, the second end portion having a proximal end
connected to the posterior end of the support portion, and
a distal end, a connector being attached to the distal end,
a second elongate implant comprising
a support portion comprising an anterior end, a
posterior end, a length extending between the anterior end
and the posterior end, and a width, the length being greater
than the width,
a first end portion extending from the support
portion, the first end portion having a proximal end
connected to the anterior end of the support portion, and a
distal end, a connector being attached to the distal end,
a second end portion extending from the support
portion, the second end portion having a proximal end
connected to the posterior end of the support portion, and
a distal end, a connector being attached to the distal end,
wherein each elongate implant includes the support
portion and the first and second end portions, and no other
elongate end portions extending from the support portion; and
two insertion tools, each one comprising a needle
comprising a helical curve, wherein the two needles comprise
2
Appeal2017-011832
Application 14/041, 77 4
different helical curves, one needle comprising a curve capable
of creating a tissue path between a patient's left obturator
foramen and a region of a levator avulsion on a patient's left side,
the other needle comprising a curve capable of creating a tissue
path between a patient's right obturator foramen and a region of
a levator avulsion on a patient's right side, and
one insertion tool comprising a needle comprising a two-
dimensional curve, the needle being capable of creating a tissue
path between a perirectal incision and a region of a levator
avulsion,
wherein each connector is capable of engaging an end of
one of the needles, and the first implant is configured to extend
between an anterior skin incision at the obturator foramen on one
side of the patient and a perirectal skin incision on the same side,
with the support portion of the first implant positioned to support
tissue of the levator avulsion on the side of the patient, the first
end portion of the first implant extending in an anterior direction
through the anterior skin incision with the connector of the first
end portion of the first implant being external to the patient, and
the second end portion of the first implant extending in a
posterior direction through the perirectal skin incision with the
connector of the second end portion of the first implant being
external to the patient; and the second implant is configured to
extend between an anterior skin incision at the obturator foramen
on an opposing side of the patient and a perirectal skin incision
on the same opposing side, with the support portion of the second
implant positioned to support tissue of the levator avulsion on the
opposing side of the patient, the first end portion of the second
implant extending in an anterior direction through the anterior
skin incision with the connector of the first end portion of the
second implant being external to the patient, and the second end
portion of the second implant extending in a posterior direction
through the perirectal skin incision with the connector of the
second end portion of the second implant being external to the
patient.
3
Appeal2017-011832
Application 14/041, 77 4
The Examiner rejected claims 14, 15, 18, 20-24, and 26-28 under
35 U.S.C. § I03(a) as unpatentable over Anderson et al. (US2006/0I95007
Al, pub. Aug. 31, 2006) ("Anderson") and Cox et al. (US 2005/0245787
Al, pub. Nov. 3, 2005) ("Cox").
We AFFIRM.
ANALYSIS
Claims 14. 15. 20-24. and 26-28
We are unpersuaded by the Appellant's argument that neither
reference discloses the multiple implants recited in independent claim 14,
nor is any disclosed implant configured for placement on a single side of a
patient, because Anderson discloses only a single sling designed to be used
across both sides of a patient. Appeal Br. 1 O; see also Reply Br. 2.
Independent claim 14 recites two implants, but the recited limitations
for each of the first and second implants are identical, and neither recites any
specific physical characteristics, other than a length greater than a width, or
characteristics that limit them to use on a single side of a patient. In this
respect, the Appellant's arguments are not commensurate with the scope of
the claim, which is broader than what is argued.
In addition, the Examiner finds Anderson discloses a sling that meets
the claim language. See Final Act. 3--4. The Examiner further finds that the
second implant, being identical to the first, is merely a duplication of parts
that is patentably insignificant. Id. at 5. The Appellant does not challenge
4
Appeal2017-011832
Application 14/041, 77 4
this finding directly2. As such, the Appellant has not demonstrated any error
with respect to the implants in the rejection.
We also are not persuaded by the Appellant's argument that
Anderson's implant is not sized and/or shaped for placement to treat levator
avulsion on one side of a patient. Appeal Br. 11. Although the Specification
describes how the implant is used to support tissue, the Specification and
claim language do not limit the size, shape, dimensions, material, or
properties of the claimed implants. See Spec. 7 lines 2-5 and 19-26, 9
lines 1--4, and 11 lines 28-29 (cited at Appeal Br. 6). The argument is thus
not commensurate with the scope of the claim, which is silent on the size
and shape of the implants claimed.
Further, the Appellant argues the three-dimensional tools of Anderson
are not sized and shaped to extend from a left ( or right) obturator foramen
and a region of a levator avulsion on either side of the patient, because they
are for use on a "different tissue path." Id. at 11. We are not persuaded by
the Appellant's argument.
Claim 14 recites:
one needle comprising a curve capable of creating a tissue path
between a patient's left obturator foramen and a region of a
levator avulsion on a patient's left side, the other needle
comprising a curve capable of creating a tissue path between a
patient's right obturator foramen and a region of a levator
avulsion on a patient's right side.
Neither the claim language nor the Specification describe the physical size
or shape of the tools, other than their generally helical shape, nor what is
necessary to be capable of creating the claimed tissue path. The Examiner
2 An argument about duplication of parts is advanced only for dependent
claim 18.
5
Appeal2017-011832
Application 14/041, 77 4
finds Anderson discloses multiple helical tools that meet the claim language.
Final Act. 4. Although Anderson does not describe the same tissue path as
claimed, the Appellant does not indicate, and we do not discern, the physical
differences that would render Anderson's needles incapable of being used in
the same tissue path as the broadly-claimed, helical needles.
We finally are unpersuaded by the Appellant's arguments that there is
no reason given in Anderson and Cox to combine Cox's two-dimensional
needles into the Anderson kit, and the Examiner's reason to avoid cross-
contamination is not a valid reason because cross-contamination issues are
not described in either reference. Appeal Br. 12.
To the extent Appellant seeks an explicit suggestion or motivation for
a combination of parts in a reference itself, this is no longer the law in view
of the Supreme Court's recent holding in KSR Int 'l Co. v. Teleflex Inc., 550
U.S. 398, 419 (2007). Nonetheless, Anderson describes a reason for
multiple copies of tools, to avoid contamination of tools through re-use.
Anderson ,r 205. In addition, the mere combination of familiar elements,
such as the tools in each of Anderson and Cox, according to known methods,
by including all in a single kit, is likely to be obvious when it does no more
than yield predictable results. KSR, 550 U.S. at 416.
The Appellant has thus failed to demonstrate error in the Examiner's
rejection of claim 14. For this reason, we sustain the rejection of claim 14,
as well as of dependent claims 15, 20-24, and 26-28 that were not argued
separately.
Claim 18
The Appellant argues that the four identical implants recited in
dependent claim 18, which are also identical to the two recited in
6
Appeal2017-011832
Application 14/041, 77 4
independent claim 14, are not obvious based on the holding in In re Harza,
274 F.2d 669 (CCPA 1960), that, according to the Appellant, is "[a]ny
modifications or benefits provided by duplicating parts overcomes such an
obviousness rejection." Appeal Br. 12-13. The Appellant further argues
that multiple implants may be needed at a single site for a patient with a
levator avulsion that is larger than the width of a single elongate implant,
and this benefit overcomes a mere duplication of parts. Id. at 13.
We are unpersuaded by the Appellant's arguments. The Appellant
provides no specific cite in Harza to support the assertion that the mere
duplication of parts is not obvious if there are modifications or benefits from
the duplication. We disagree with this interpretation, because Harza instead
states that the mere duplication of parts has no patentable significance unless
a new and unexpected result is produced. Harza, 276 F.2d at 671. Here,
merely adding more implants so that a large avulsion can be treated is not a
new or unexpected result, since any ordinary artisan would know that more
implants would cover more area, or provide more strength, than a single
implant. We discern nothing different from the duplication of implants in
claim 18 from the duplication of implants in claim 14. For this reason, we
sustain the rejection of claim 18.
7
Appeal2017-011832
Application 14/041, 77 4
DECISION
We affirm the rejection of claims 14, 15, 18, 20-24, and 26-28 under
35 U.S.C. § 103(a).
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
8