Ex Parte Gall et al

Patent Trial and Appeal Board

Oct 29, 2012

10598080 (P.T.A.B. Oct. 29, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

PATENT TRIAL AND APPEAL BOARD
__________

Ex parte KENNETH GALL, JEFFREY TYBER, CHRIS YAKACKI,
and REED BARTZ
__________

Appeal 2011-013007
Application 10/598,080
Technology Center 3700
__________

Before DONALD E. ADAMS, ERICA A. FRANKLIN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims directed to a method of anchoring a cable
member or ligament to a bone. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
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Application 10/598,080

2
STATEMENT OF THE CASE
Claims 46, 51, 52, 55, 56, and 139-141 are on appeal, and can be
found in Appendix A of the Appeal Brief (App. Br. 17-18). Claim 46 is the
sole independent claim and is representative of the claims on appeal, and
reads as follows (emphasis added):
46. A method comprising:
inserting a cable member into a recess in a bone;
inserting a retention device containing a shape memory polymer
into the recess while the shape memory polymer is in a temporary pre-
implantation shape due to a shape memory effect of the shape
memory polymer;
positioning the retention device in the recess while the shape
memory polymer is in the temporary pre-implantation shape such that
the retention device contacts the cable member and the bone; and
causing the shape memory polymer to change its shape through the
shape memory effect from the temporary pre-implantation shape
toward an unconstrained shape of the shape memory polymer, thereby
fixing the cable member to the bone with the retention device.

The following grounds of rejection are before us for review:
1. The Examiner has rejected claims 46, 51, 55, and 139 under 35
U.S.C. § 103(a) as unpatentable over Dovesi1 in view of Lendlein.2
2. The Examiner has rejected claim 52 under 35 U.S.C. § 103(a) as
unpatentable over Dovesi in view of Lendlein and Chan.3

1 Dovesi et al., US 2002/0165547 A1, published Nov. 7, 2002.
2 Lendlein et al., Biodegradable, Elastic Shape-Memory Polymers for
Potential Biomedical Applications, 296 SCIENCE, 1673-1676 (2002).
3 Chan, US 2002/0188298, published Dec. 12, 2002.
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3. The Examiner has rejected claims 140-141 under 35 U.S.C.
§ 103(a) as unpatentable over Dovesi in view of Lendlein and
Boneau.4
4. The Examiner has rejected claims 46 and 56 under 35 U.S.C. §
103(a) as unpatentable over Li5 in view of Lendlein.

ISSUES
The Examiner takes the position that Dovesi disclosed a method of
inserting a cable member into a bone recess (Ans. 4), followed by inserting a
retention device (Ans. 4), positioning the device and attaching the cable
member to the bone with compression (Ans. 5). As acknowledged by the
Examiner, Dovesi did not disclose a “retention device containing a shape
memory polymer” (Ans. 5) but did suggest the “use of a shape memory
material” in the retention device (Ans. 5). The Examiner concludes that it
would have been obvious to use a shape memory polymer, which is
considered to be a shape memory material, in Dovesi’s disclosed retention
device. (Ans. 6.)
Appellants contend that the Examiner has not addressed the
limitations of “positioning [of] the retention device in the recess while the
shape memory polymer is in the temporary pre-implantation shape such that
the retention device contacts the cable member and the bone,” and “fixing
the cable member to the bone with the retention device.” (App. Br. 6.)

4 Boneau, US 5,879,382, issued Mar. 9, 1999.
5 Li, US 5,505,735, issued Apr. 9, 1996.
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(Dovesi

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FF3. After positioning the female element 6 in the tunnel 3 so that the
portion 11 anchors in the cortex of the bone 1, the new tendon T is
guided there through so that its end portions protrude from the
tunnel 3. Finally, the male element is inserted by screwing and,
thanks to its convex shape, forces the tendon T to engage between the
turns 8 of the female element, while the washer 16, by abutting
against the cortex, blocks its end portions.
(Dovesi ¶0026.)
FF4. “The device can be made of metal (titanium or steel) or of composite,
absorbable or shape-memory materials.” (Dovesi ¶0030.)
FF5. “The elongated element can be constituted by a gracilis tendon or
semitendinosus tendon taken from the patient or by a string of synthetic
filaments.” (Dovesi ¶0003.)
FF6. Lendlein disclosed that:

Shape-memory polymers possess the ability to memorize a permanent
shape that can substantially differ from their initial temporary shape.
Large bulky devices could thus potentially be introduced into the body
in a compressed temporary shape by means of minimally invasive
surgery and then be expanded on demand to their permanent shape to
fit as required.
(Lendlein 1673-1674)
FF7. Chan disclosed that the cable member can be “ligament or tendon or
other tissue harvested from the patient's own tissue (known as autograft
tissue)” (Chan ¶0008) or a “ligament or tendon or other tissue harvested
from another human donor (known as allograft tissue)” (Chan ¶0009).
FF8. Li disclosed a tendon anchoring system where the “surgical anchor is
provided which is adapted to hold repair or replacement material in
proximity to bone in a manner which promotes the growth of a permanent
attachment therebetween.” (Li col. 12, ll. 55-58.) The surgical anchor can
App
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13007
/598,080
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iliently
(Li col.
wardly

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from body 14 when in their normal unstressed condition.” (Li col. 7, ll. 32-
35.)

PRINCIPLES OF LAW
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability. For the same reason, if 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.
Id. at 417. It is proper to “take account of the inferences and creative steps
that a person of ordinary skill in the art would employ.” Id. at 418. See also
id. at 421 (“A person of ordinary skill is also a person of ordinary creativity,
not an automaton.”). Like our appellate reviewing court “[w]e will not read
into a reference a teaching away from a process where no such language
exists.” DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick
Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006).

ANALYSIS
Grounds 1-3: Obviousness over Dovesi in view of Lendlein
The Examiner’s statement of rejection and rebuttal with respect to the
combination of Dovesi and Lendlein is found at pages 4-8 and 11-13 of the
Answer. The Examiner finds that Dovesi disclosed a method of inserting a
cable member (ligament) into a recess in a bone, followed by inserting a
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retention device into the recess. (Ans. 4.) To anchor the cable member the
“ret[ention] device applies a compressive force to the cable member against
the bone…” (Ans. 5.) The Examiner finds that “Dovesi discloses the use of
a shape memory material” in a ligament retention device. (Ans. 5.) The
Examiner acknowledges that Dovesi does “not disclose the retention device
containing a shape memory polymer such that [it] is inserted in a temporary
pre-implantation shape and causing the polymer to change shape after
implantation, thereby fixing the cable member to the bone with the retention
device.” (Ans. 5.) The Examiner finds that “Lendlein discloses that shape
memory polymers allow for implants to be placed through small
incisions . . . wherein bulkier devices can be introduced into the body in a
compressed temporary shape then expanded on demand . . . wherein the
shape memory polymer can be activated by heating,” (Ans 6.) The
Examiner acknowledges that “[w]hile Dovesi does not go into much detail
about the use of shape memory materials, it is known within the art that
there is a shape change feature of shape memory materials.” (Ans. 11.)
Appellants’ arguments are that the Examiner has not addressed two
elements of rejected claim 46. Specifically, the Examiner has not addressed
the “positioning [of] the retention device in the recess while the shape
memory polymer is in the temporary pre-implantation shape such that the
retention device contacts the cable member and the bone,” and the limitation
of “fixing the cable member to the bone with the retention device.” (App.
Br. 6.)
We are not persuaded by Appellants argument. Here the claim is
directed to a method of attaching a tendon (cable member) to a bone by
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9
inserting a tendon and a retention device into the bone. The retention device
of Devesi is made up of two components that help secure the tendon to the
bone. (FFs 1-3.) As set out by the Examiner, Dovesi’s method contained
the steps of inserting the cable member into a bone recess (Ans. 4), inserting
a retention device (Ans. 4), positioning the device and attaching the cable to
the bone with compresion (Ans. 5). As acknowledged by the Examiner,
Dovesi did not disclose a “retention device containing a shape memory
polymer” (Ans. 5) but did suggest the “use of a shape memory material” in
the retention device (Ans. 5). The Examiner found that it would have been
obvious to “modify the device of Dovesi to include a shape memory
polymer” (Ans. 6) as suggested by Dovesi’s alternative materials (FF3), in
view of Lendlein “because shape memory polymers are known shape
memory materials . . . [and] bulkier devices can be introduced into the body
in a compressed temporary shape” (Ans. 6). We agree with the Examiner, as
such a modification involved combining familiar elements according to
known methods to yield a predictable result. See KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 416 (2007).
Appellants assert that “Dovesi only mentions shape-memory materials
as an alternative material for Dovesi's devices, none of which are described
as changing shape.” (App. Br. 7.) Appellants assert that “the function of
Dovesi's device, that of fixing tendon to bone, operates entirely without a
change in shape.” (App. Br. 8.) Appellants assert that there is no motivation
to combine the references of Dovesi and Lendlein; and that Lendlein teaches
away from a combination with Dovesi because the “shape memory polymers
[are] for low force environments.” (App. Br. 9.)
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We are not persuaded by Appellants’ argument. As explained by our
reviewing court “motivation may be found implicitly in the prior art. We do
not have a rigid test that requires an actual teaching to combine before
concluding that one of ordinary skill in the art would know to combine
references.” Alza Corp. v. Mylan Laboratories, Inc., 464 F3d 1286, 1291
(2006). Here Dovesi explicitly disclosed the use of alternative materials. A
prior art reference is said to teach away from an Applicant’s invention
“when a person of ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference, or would be led
in a direction divergent from the path that was taken by the applicant.” In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). “The prior art’s mere disclosure
of more than one alternative does not constitute a teaching away from any of
these alternatives because such disclosure does not criticize, discredit, or
otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195,
1201 (Fed. Cir. 2004). Dovesi specifically suggests alternative materials for
the production of the retention device including the use of shape-memory
materials. (FF3.)
Appellants assert that at least “831.9N (or 187 pounds of force) as the
average pull-out tensile strength of a bone fixation system” is required as set
out in the Specification. (App. Br. 9.)
Appellants argument directed to the force and tensile strength of the
shape memory polymer are not persuasive because these limitations are not
recited in the claims. “[W]hile it is true that claims are to be interpreted in
light of the specification . . . , it does not follow that limitations from the
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specification may be read into the claims. . . . It is the claims that measure
the invention.” Sjolund v. Musland, 847 F.2d 1573, 1582 (Fed. Cir. 1988).
Appellants urge us not to “accept the Examiner’s invitation to ignore
the important Graham analysis of setting forth the relevant level of ordinary
skill and ascertain the differences between the prior art and the claims.”
(Reply Br. 2.)
We are not persuaded by Appellants’ arguments that the Examiner has
failed to identify the level of ordinary skill in the art. With regards to the
level of ordinary skill in the art as noted by our reviewing court, “the
absence of specific findings on the level of skill in the art does not give rise
to reversible error ‘where the prior art itself reflects an appropriate level and
a need for testimony is not shown.’” Okajima v. Bourdeau, 261 F.3d 1350,
1355 (Fed. Cir. 2001). In cases were the patents and prior art are “easily
understandable, a factual determination of the level of skill in the art was
unnecessary. . . . [one] cannot, argue that an unnecessary fact is material. It
makes only a naked allegation that some unspecified higher level of skill
should have been applied.” Chrome-Time Equipment Inc. v. Cumberland
Corp., 713 F.2d 774, 779 (Fed. Cir.1983). The Patent Office satisfies its
initial burden of production by “adequately explain[ing] the shortcomings it
perceives so that the applicant is properly notified and able to respond.”
In re Jung at 637 F.3d 1356, 1362 (citing Hyatt v. Dudas, 492 F.3d 1365,
1370 (Fed. Cir. 2007)). The Examiner cited references in the art of
implantable surgical devices, the level of ordinary skill in this area is high
and would be that of a medical device engineer or an orthopedic surgeon
having knowledge of methods for inserting such devices into a bone. We
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find that the cited references reflect the appropriate level of skill in the art
and Appellants have not established otherwise with persuasive evidence.
We are not persuaded by Appellants’ contention that the Examiner
failed to ascertain the differences between the prior art and the claims (FFs
1-6). The Examiner acknowledged that Dovesi disclosed the use of a “shape
memory material, where the retain[tion] device applies a compressive force
to the cable member against the bone (see paragraph 27) but does not
disclose the retention device containing a shape memory polymer.” (Ans.
5.)
We conclude that the preponderance of the evidence of record
supports the Examiner’s conclusion that the combination of Dovesi and
Lendlein renders obvious the method of claim 46. We thus affirm the
rejection of claim 46 under 35 U.S.C. § 103(a) as being obvious. As claims
51, 52, 55, and 139-141 have not been argued separately, they fall together
with claim 46 as acknowledged by Appellants (App. Br. 5). 37 C.F.R. §
41.37(c)(1)(vii).

Ground 4: Obviousness over Li in view of Lendlein.
The Examiner’s statement of rejection and rebuttal with respect to the
combination of Li in view of Lendlein may be found at pages 8-11 and 12-
15 of the Answer. Li disclosed a tendon positioning device with a shape-
memory alloy. The Examiner finds that the combination of Li and Lendlein
is obvious
because shape memory polymers are known shape memory materials,
wherein a shape memory polymer is a simple substitution of one
known shape memory material for another to obtain predictable
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results of expanding a shape memory material from a pre-implantation
state to a post-implantation state, wherein shape memory polymers
allow for implants to be placed through small incisions, where shape
memory polymers possess the ability to memorize permanent shape
that can substantially differ from their initial temporary shape,
wherein bulkier devices can be introduced into the body in a
compressed temporary shape.
(Ans. 10.)

The Examiner found that “[w]ith the combination of Li and Lendlein, the
barbs of Li are still able to be implanted in a smaller state and once in place
in the soft cancellous area of the bone, the barbs can be activated to expand
to enhance the fixation of the barbs in the bone tunnel.” (Ans. 14.)
Appellants assert that the Examiner has not addressed at least two
elements of rejected claim 46. Specifically, Appellants assert that the
Examiner has not addressed the “positioning [of] the retention device in the
recess while the shape memory polymer is in the temporary pre-implantation
shape such that the retention device contacts the cable member and the
bone,” and the limitation of “fixing the cable member to the bone with the
retention device.” (App. Br. 12.) Appellants also assert that “Li fails to
reach or disclose any use of the barb in any memorized shape.” (App. Br.
13.) Appellants additionally assert that there is no motivation to combine Li
and Lendlein because “Li only teaches shape memory alloys without any
memorized shape.” (App. Br. 13.) Appellants also assert that Lendlein
teaches away from the combination because the “pull out tensile strength of
a bone fixation system” (App. Br. 14) must be at least “831.9 N (or 187
pound of force)” (App. Br. 14), while the combination would arrive at a
device having only “3.7 pounds of force” (App. Br. 14). Further, Appellants
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assert that the Examiner’s reliance on “‘common knowledge in the art’
provides ‘shape memory polymer with sufficient strength to be placed in the
bone’ that is sufficient to make the Li device functional for fixing tendon to
bone” violates the Graham analysis and constitutes a new ground of
rejection. (Reply Br. 3-4.)
We are not persuaded by Appellants’ argument that there is no
motivation to combine the references. Li disclosed a tendon anchoring
system that uses a shape-memory metal to attach a tendon to the bone. (FFs
8-10.) The method disclosed by Li includes the steps of inserting a cable
member attached to a retention device into a recess in a bone, positioning the
device, and fixing it into the bone. (FFs 8-10.) Lendlein disclosed that there
are many known shape memory materials including polymers as well as
metallic alloys. (Lendlein p 1674, col. 1, 2nd paragraph.) “The combination
of familiar elements according to known methods is likely to be obvious
when it does no more than yield predictable results.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 416 ( S. Ct. 2007). “The test for obviousness is
what the combined teachings of the references would have suggested to one
of ordinary skill in the art.” In re Young, 927 F.2d 588, 591 (Fed. Cir.
1991). During the process of positioning Li’s device the barbs are
constrained and once relaxed will spring back into the outward position.
(FF10.) The Examiner acknowledged that Li disclosed a device with barbs
made of a shape memory material were the barbs extend “outward to a larger
shape to fixate the retention member and cable member in bone but does not
disclose the retention device containing a shape memory polymer such that
is inserted in a temporary pre-implantation shape and causing the polymer to
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change shape after implantation.” (Ans. 10.) The Examiner found that it
would have been obvious “to modify the device of Li to include a shape
memory polymer in view of Lendlein because shape memory polymers are
known shape memory materials, wherein a shape memory polymer is a
simple substitution of one known shape memory material for another to
obtain a predictable result.” (Ans. 10.)
We are also not persuaded by Appellants’ argument that the
references teach away from the combination of Li and Lendlein, that the
references do not teach a tensile strength “831.9 N (or 187 pound of force)”
(App. Br. 14), and that the Examiner has improperly relied on “common
knowledge.” A prior art reference is said to teach away from an Applicant’s
invention “when a person of ordinary skill, upon reading the reference,
would be discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was taken by the
applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). We have found
nothing in the references that would lead the ordinary artisan away from
making the combinations as suggested by the Examiner. The Examiner
found that the tensile strength limitations on which Appellants arguments are
based are not found in the claims. (Ans. 14-15.) Because the Examiner’s
rebuttal asserting “common knowledge” is directed to the tensile strength
limitation in Appellants arguments, we do not agree with Appellants that the
Answer raised a new ground of rejection.
For the foregoing reasons, we conclude that the preponderance of the
evidence of record supports the Examiner’s conclusion that the combination
of Li and Lendlein renders obvious the method of claim 46. We thus affirm
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the rejection of claim 46 under 35 U.S.C. § 103(a) as being obvious. As
claim 56 has not been argued separately, it falls together with claims 46 as
acknowledged by Appellants (App. Br. 10). 37 C.F.R. § 41.37(c)(vii).

SUMMARY
We affirm the rejection of claims 46, 51, 55, and 139 under 35 U.S.C.
§ 103(a) as unpatentable over Dovesi in view of Lendlein.
We affirm the rejection of claim 52 under 35 U.S.C. § 103(a) as
unpatentable over Dovesi in view of Lendlein and Chan.
We affirm the rejection of claims 140-141 under 35 U.S.C. § 103(a)
as unpatentable over Dovesi in view of Lendlein and Boneau.
We affirm the rejection of claims 46 and 56 under 35 U.S.C. § 103(a)
as unpatentable over Li in view of Lendlein.

AFFIRMED

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