Ex Parte Gedet et al

Patent Trials and Appeals Board

May 14, 2019

13778816 - (D) (P.T.A.B. May. 14, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/778,816 02/27/2013
52470 7590 05/16/2019
MORGAN, LEWIS, & BOCKIUS LLP - SYNTHES
1701 Market Street
Philadelphia, PA 19103
Philippe Gedet
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.
060960-5085-us 3767
EXAMINER
SCHWIKER, KATHERINE H
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
05/16/2019 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):
phpatentcorrespondence@morganlewis.com
judith.troilo@morganlewis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PHILIPPE GEDET, BEAT LECHMANN, and CYRIL VOISARD
Appeal 2018-005463
Application 13/778,816
Technology Center 3700
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
JOHN G. NEW, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner's
decision to reject claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We reverse.
1 The Appeal Brief lists Depuy Synthes Products Inc., the assignee of record,
as the real party in interest. Appeal Br. 2. We have considered, and herein
refer to, the Specification of Feb. 27, 2013 ("Spec."); Final Office Action of
May 16, 2017 ("Final Act."); Appeal Brief of Jan. 16, 2018 ("Appeal Br.");
Examiner's Answer of March. 6, 2018 ("Ans."); and Reply Brief of May 4,
2018 ("Reply Br.").
Appeal 2018-005463
Application 13/778,816
STATEMENT OF THE CASE
The Specification describes a suture that exhibits superior knot tying
and knot security properties. "[T]he suture comprising a non-load bearing
core and a load bearing sheath surrounding the non-load bearing core''
(Spec. 1, ~2).
Claims 1, 4-14, and 17-22 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief (Appeal Br. 24). Claims 1 and 17 are
representative of the claims on appeal, and reads as follows:
1. A fastening element configured to be tied into one or more
knots, the fastening element comprising:
a r101doad bearing core comprising a first biocornpatib1e
po]ymer and having a tensile strength ranging from 5 l\![Pa to 20
MPa and a Durometer Hardness Type A value ranging from
15 to 30; and
a load bearing sheath comprising a second biocornpatibk
polymer,
\vherein the load bearing sheath surrounds the non-1oad
bearing core, vvherein the non-load bearing core is configured to
collapse when the fastening element is tied into the one or more
knots, wherein the non-load bearing core has a radius that is
larger than a thickness of the load bearing sheath when the non-
1oad bearing core is not collapsed, and \vherein the fastening
element has a tensile strength value ranging from l 00 N to
400N.
17. A suture configured to be tied into one or more knots. the
~ .
suture comprising:
a non-load bearing core cornJJrising a first biocompatibk
(:.; - (:.;
polymer and having a tensile strength ranging from 5 1\tfPa to 20
l'v1Pa and a Durometer Hardness Type A value ranging from
15 to 30; and
a load bearing sheath comprising a second biocompatible
po1ymer, wherein the load bearing sheath surrounds the non-
load bearing core,
\vherein the non-load bearing core is configured to
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Appeal 2018-005463
Application 13/778,816
collapse when the suture is tied into the one or more knots,
whereh1 the mm-load bearing core has a radius that is larger
than a thickness of the load bearing sheath when the non-foad
bearing core is not coflapsed, wherein the suture has a tensile
strength value ranging from 100 N to 400 N, and wherein the
suture has a diameter which is deformable, upon application of
a radial deformation force, such that the suture diameter is
reducible by up to 40~'o-
Examiner relies on the following prior art to sho".v unpatentability:
Crane
Kovfman et al .,
US 2005/0130540 A 1
t.JS 2005/0149119 Al
(hereinafter "Koyfman")
Ferguson US 2006/0025818 A 1 ,_.
F TTS· 'J(' ···6 1(' 1 -..;,.,;··· A1 . 1 oerster l .. ~ ""'Jl1 .1 J '.).,.)~X . .
Maver US 2008/028 l 355 A 1
·'
(hereinafter "J\fayer")
Utkhede US 2009/0104243 Al
(hereinafter "Utkhede")
Avelar US 2013/0226234 Al
(hereinafter "A velar")
June 16, 2005
July 7, 2005
T.'."b 2 '")0')6 r1;: . , "' l ._.
Julv 13, 2006
Nov, LL 2008
Apr. 23, 2009
Appellant requests review of following rejections made by Examiner:
L Claims 1, 4, 5, 7, 11, 14, and 17-19 under 35 U.S.C. § 103(a) as
being obvious over Ferguson (Final Act. 3-9).
IL Claims 6 and 8-10 under 35 U.S.C. § 103(a) as being obvious
over Ferguson and Koyfman (Final Act. 10-11 ).
HI. Claims 12 and 13 under 35 U.S.C. § 103(a) as being obvious
over Ferguson and Utkhede (Final Act. 11-12).
IV, Claim 20 under 35 U.S.C. § 103(a) as being obvious over
Ferguson and Avelar (Final Act. 12).
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Application 13/778,816
V. Claim 21 under 35 U.S.C. § 103(a) as being obvious over
Ferguson and Mayer (Final Act. 12-13).
VI. Claim 22 under 35 U.S.C. § 103(a) as being obvious over
Ferguson and Crane (Final Act. 13-14).
VJL Claims 1, 4, 5, 7, 11, 14, and 17----19 under 35 U.S.C. § 103(a) as
being obvious over Ferguson and Foerster(Final Act. 14-20).
VIII. Claims 6 and 8----10 under 35 U.S.C. § 103(a) as being obvious
over Ferguson, Foerster, and Koyfman (Final Act. 20-21 ).
IX. Claims 12 and 13 under 35 U.S.C. § 103(a) as being obvious
over Ferguson, Foerster, and Utkhede (Final Act. 21-22).
X. Claim 20 under 35 U.S.C. § 103(a) as being obvious over
Ferguson, Foerster, and Avelar (Final Act. 22-23).
XI. Claim 21 under 35 U.S.C. § 103(a) as being obvious over
Ferguson, Foerster, and Mayer (Final Act. 23).
XII. Claim 22 under 35 U.S.C. § 103(a) as being obvious over
Ferguson, Foerster, and Crane (Final Act. 24).
1. Obviousness over Ferguson.
Examiner found Appellant's suture and Ferguson's suture "are formed
of the same structure ( outer sheath and inner core), made of the same
materials (high molecular weight and polyester), perform the same function
( collapse when tied into knots), and provide the same advantage (improved
knot strength)" (Ans. 10-11). Additionally, Examiner found that Ferguson's
suture has the same overall tensile strength as the presently claimed suture
(id.). Examiner found that although Ferguson does not expressly teach that
the non-load bearing core has a tensile strength ranging from 5 MPa to
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Application 13/778,816
20 MPa, a Durometer Hardness Type A value ranging from 15 to 30, or a
radius of the non-load bearing core that is larger than a thickness of the load
bearing sheath when the non-load bearing core is not collapsed, that these
elements "would have been an obvious matter of design choice to a person
of ordinary skill in the art" in order to arrive at the claimed features of the
non-load bearing core (Final Act. 4-7).
Appellant contends that Examiner's reliance on obvious design choice
for finding three claim elements (Appeal Br. 7) in order to arrive at the
conclusion that Ferguson meets the claimed tensile strength range of 100 N
to 400 N is in error (Reply Br. 5).
The issue is whether the preponderance of evidence of record supports
Examiner's conclusion that Ferguson renders the fastening element or suture
as claimed obvious.
Findings of Fact
FFl. Ferguson teaches a suture which "generally includes a core
comprising polyester fibers which are twisted at about 1.5 turns per
inch. The core is encased in a sleeve comprising braided, long-chain,
high molecular weight polyethylene terephthalate threads" (Ferguson
,-J 7). Fig. 1, reproduced below, shows Ferguson's suture:
Fig. 1, shows a cross-sectional view of a suture (id. ,-i 9). The suture
10 includes a core 12 and an outer sleeve 14 (id. ,-i 14).
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Application 13/778,816
FF2. Ferguson teaches that the "core permits a cushioning deformation of
the cross-sectional shape of the cover when the suture is in a bent
configuration" and that the "cushioning core provides this protection
by allowing the suture to easily bend" (id. f 19).
FF3. Ferguson teaches that their suture "provides a further improvement on
existing suture materials by providing a suture that embodies high
tensile strength, high knot strength and good knot security, and which
at the same time is very flexible" (id. ,i 7).
FF4. Ferguson teaches a preferred embodiment, wherein the suture
exhibited "an unexpectedly high breaking strength of about 108
pounds" and that "the knot strength of the suture of the preferred
embodiment is about 46.3 pounds" (id. ,i 20).
Analysis
Examiner found that because Appellant's suture and Ferguson's
suture "are formed of the same structure ( outer sheath and inner core),
made of the same materials (high molecular weight and polyester),
perform the same function ( collapse when tied into knots), and provide the
same advantage (improved knot strength)" (Ans. 10-11; FF l-FF2), it
would be an obvious matter of design choice to modify Ferguson's core to
have the same features as the claimed non-load bearing core (Final Act. 4-
7).
"[E]xaminer bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability."
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Here, Examiner provides no evidence or reason why the tensile
strength values of 5-20 MPa and hardness values of 15-30, would simply be
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Application 13/778,816
a design choice. See KSR Int'! v. Teleflex Inc., 550 U.S. 398, 401 (2007)
(There must be "a reason that would have prompted a person of ordinary
skill in the relevant field to combine the elements in the way the claimed
new invention does."). A patent composed of several elements is not proved
obvious merely by demonstrating that each of its elements was,
independently, known in the prior art. Id. at 418. It is important to identify
a reason that would have prompted a person of ordinary skill in the relevant
field to combine the elements in the way the claimed invention does. Id.
Examiner's mere assertion that several elements would have been an
obvious "design choice," without supporting facts and reasoning explaining
why this is so, fails to provide such a reason for why the claimed invention
would have been obvious. Here, the point is that the elements described in
the art were not disclosed as meeting the particular values as claimed.
Although Examiner found that the core of Ferguson is made of the
same material as Appellant's core (i.e., polyester; FFl), as pointed out by
Appellant, polyester is a class of polymers that encompasses a wide variety
of materials having dissimilar tensile strengths - in some cases more than 30
times the claimed range (See Appeal Br. 9, (citing, e.g., US 3,942,532, Table
l; US 5,102,420, Table 1)). Examiner has not explained how or why an
ordinarily skilled artisan would have selected a particular polyester material
with the claimed hardness and strength values within the claimed ranges, in
combination with the claimed radius size. In other words, Examiner has not
provided a sufficient articulated rationale as to why the ordinary artisan
would have selected materials falling within the claimed ranges. Just
because one could make such a selection does not provide a reason to do so.
Design choice still requires some convincing line of reasoning for the artisan
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Application 13/778,816
to select a particular material that meets the claimed features. In re Chu, 66
F.3d 292 (Fed. Cir. 1995); see, e.g., Rexnord Indus., LLC v. Kappas, 705
F.3d 1347, 1356 (Fed. Cir. 2013) (where the prior art taught that conveyor
belt elements are spaced to avoid pinching fingers, the claimed "10mm
dimension [is] a design choice that takes account of the size of fingers and
other small objects").
Appellant also contends that "Ferguson does not disclose a tensile
strength of 46.3lbs ( or 205.96 N) as misstated by the Examiner, and
therefore the Examiner's conclusion that Ferguson meets the claimed tensile
strength range of 1 OON to 400N is clearly in error" (Reply Br. 5).
To arrive at the claimed tensile strength values of from 100 N to 400 N,
Examiner at first found that Ferguson discloses a tensile strength of 480 N
(46.3lbs) a value that is outside the claimed range (Final Act. 6). Examiner
further contends that optimization of the tensile strength would have been
obvious to one having ordinary skill in the art at the time the invention was
made (id.). In the Answer, Examiner then provides another calculation and
then found that the value of 46.3 lbs. disclosed in Ferguson is actually equal
to 205.96 N (Ans. 3-4), and concludes that the suture of Ferguson has an
overall tensile strength of 205.96 N, which falls within the claimed range of
100 N-400 N (Ans. 4-5).
We do not agree with Examiner's conclusion based on Ferguson's
teachings. Ferguson teaches two strength values, a suture breaking strength
of about 108 pounds, which is equivalent to 480N, and a knot strength of the
suture of about 46.3 pounds, which is equivalent to 205.96N (FF4; Reply Br.
5-6). As pointed out by Appellant, Ferguson makes a distinction between
tensile strength (suture breaking strength) and knot strength (see Reply Br.
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Application 13/778,816
5; FF2). We agree with Appellant and find that the knot strength value
disclosed by Ferguson is not the same as the claimed fastening element
tensile strength. Here, the plain language of the claims, are not directed to a
knot strength, but rather generically recite that the fastening element or
suture has a tensile strength value ranging from 100 N to 400 N. Examiner
has not articulated why the knot strength instead of straight tensile strength
is the more applicable measure as applied to the claims. Accordingly, we
find that Examiner's reliance on Ferguson's knot strength as meeting the
requisite tensile strength of the fastening element is not correct.
Additionally, Examiner has not provided sufficient reasoning to optimize the
suture of Ferguson to arrive at a tensile strength within the claimed range,
particularly in combination with the other claimed core limitations at issue
above.
Consequently, based on the record before us, the preponderance of the
evidence does not support Examiner's conclusion of obviousness.
II.- VI. Obviousness over Ferguson in combination with either Koyfman,
Utkhede, Avelar, Mayer, and Crane
Examiner relied upon Koyfman, Utkhede, A velar, Mayer, and Crane
in combination with Ferguson to reach various limitations set out in the
dependent claims, but did not rely on Koyfman, Utkhede, A velar, Mayer, or
Crane to address the missing Durometer Harness values, radius, and tensile
strength values at issue in claims 1 and 1 7. For the same reasons set out
above(!.), we reverse Examiner's obviousness rejection over Ferguson in
combination with Koyfman, Utkhede, A velar, Mayer, or Crane.
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vYL Obviousness over Ferguson and Foerster
Examiner relied on Ferguson as discussed above (J. ), and found that
"it would have been obvious to one of ordinary skill in the art, at the time the
invention was made, to modify Ferguson to have the non-load bearing core
have a radius that is larger than a thickness of the load bearing sheath when
the non-load bearing core is not collapsed as taught by Foerster, for the
purpose of increasing the strength of the suture to improve its holding
ability" (Final Act. 18).
The issue is whether the preponderance of evidence of record supports
Examiner's conclusion that Ferguson and Foerster render the fastening
element or suture as claimed obvious.
Findings of Fact
FF5. Foerster teaches a "suture strand having high tensile strength as well as
clinically acceptable knot-tying characteristics. Briefly, the suture
strand comprises a core formed of a plurality of core fibers of a first
material, surrounded by a cover including a plurality of cover fibers
made of a second material different than the first material" (Foerster
i17).
FF6. Foerster teaches that the core material "is a high tensile strength, high
tenacity material such as ultrahigh molecular weight long chain
polyethylene" (id.).
FF7. Foerster teaches that "the size of the core 12b is preferably selected to
increase [] the composite suture strength of a suture" (id.i130).
Analysis
Appellant contends that "Examiner's combination of Ferguson and
Foerster fails to disclose or teach all the limitations of claims 1 and 17, and
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Application 13/778,816
that the differences between Ferguson and Foerster and the claimed
invention would not have been obvious to one of ordinary skill in the art"
(Appeal Br. 18).
Examiner found that Foerster teaches a suture that comprises a core
surrounded by a cover, wherein the core "has a radius that is larger than a
thickness of the sheath when the core is not collapsed" (Final Act. 18; FF5,
FF7). Here, Examiner identifies a reason why an ordinarily skilled
artisan may modify the core radius of Ferguson "for the purpose of
increasing the strength of the suture to improve its holding ability" (Final
Act. 18). However, Foerster' s core is explicitly described as "high strength,
high molecular weight, high tenacity material" (Appeal Br. 20, FF6), and we
find no teaching in Foerster regarding a non-load bearing core having a
tensile strength ranging from 5 MPa to 20 MPa and a Durometer Hardness
Type A value ranging from 15 to 30, or a tensile strength from 100 N-400 N
at issue above in claims 1 and 1 7. Because Forester does not make up for
the deficiencies in Ferguson (see above 1.), the preponderance of the
evidence does not support Examiner's conclusion of obviousness.
VIII. -XI. Obviousness over Ferguson and Foerster in combination with
either Koyfman, Utkhede, Avelar, Mayer, or Crane
Examiner relied upon Koyfman, Utkhede, A velar, Mayer, and Crane
to reach various limitations set out in the dependent claims, but did not rely
on Koyfman, Utkhede, A velar, Mayer, and Crane to address the missing
Durometer Harness values, radius, and tensile strength values at issue in
claims 1 and 17. For the same reasons set out above (VII.), we reverse
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Application 13/778,816
Examiner's rejection over Ferguson and Foerster, in combination with
Koyfman, Utkhede, A velar, Mayer, or Crane.
SUMMARY
We reverse the rejection of all claims.
REVERSED
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