Ex Parte Boyce et al

Patent Trial and Appeal Board

Oct 29, 2013

10433523 (P.T.A.B. Oct. 29, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte TODD M. BOYCE and LAWRENCE A. SHIMP1
__________

Appeal 2011-012943
Application 10/433,523
Technology Center 3700
__________

Before DONALD E. ADAMS, ERIC GRIMES, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
orthopedic implant, which have been rejected for obviousness. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

1 Appellants identify the Real Party in Interest as Osteotech, Inc. (Appeal Br.
2).
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STATEMENT OF THE CASE
Claims 1-17, 20, 22-25, and 27-31 are on appeal. Claims 1 and 13 are
illustrative and read as follows:
1. An implant comprising a quantity of flexible, elongated elements,
at least some of which being one or more of filaments, threads, fibers, or
strips comprising bone-derived tissue, and at least some of which possess
connective tissue-healing activity, substantially all the elements being
arranged in a braid, plied thread, spun yarn, or twist in substantially common
alignment with a common axis, wherein the elongated elements have been
modified at one or both ends to allow for the attachment of bone to the end,
wherein the implant is substantially longer than it is wide, and wherein the
implant is substantially longer than it is thick.

13. The implant of claim 1 wherein elongated elements in the form of
threads are assembled into yarns and the yarns are assembled into a braid.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 1-7, 9-12, 14, 15, 20, 22-25, and 27-31 based on Chvapil2
and Gendler3 (Answer 4) and
• Claims 8, 13, 16, and 17 based on Chvapil, Gendler, and Boyce4
(Answer 6).
I.
Issue
The Examiner has rejected most of the claims on appeal as obvious
based on Chvapil and Gendler (Answer 4). The Examiner finds that Chvapil
discloses an implant that would meet the limitations of claim 1 except that

2 Chvapil, EP 0 306 018, published Mar. 8, 1989.
3 Gendler, US 5,092, 887, issued Mar. 3, 1992.
4 Boyce et al., WO 99/39757, published Aug. 12, 1999.
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its “filaments or fibers are not bone-derived but are rather derived from
tendon or ligament fibers” (id. at 5).
The Examiner finds that Gendler discloses “utiliz[ing] bone-derived
tissue to make tendon or ligament substitutes” (id.) and concludes that it
would have been obvious “to utilize the bone-derived elements (strips or
rods) of Gendler as the other fibers or as replacements for the fibers or
filaments of Chvapil” because doing so would simply be substituting known
elements to yield a predictable result (id.).
Appellants contend that combining the teachings of Chvapil and
Gendler would not have been obvious because the references teach away
from the proposed combination (Appeal Br. 8-10) and provide no reason to
make the proposed combination (id. at 10-11). Appellants also contend that
the references do not disclose the ratios required by claims 11, 12, 28, and
29 (id. at 11-12).
The issues presented are whether a preponderance of the evidence
supports the Examiner’s conclusion that it would have been obvious to use
Gendler’s bone-derived fibers in Chvapil’s implant, and whether the
references would have suggested the ratios required by the separately argued
claims.
Findings of Fact
1. Chvapil discloses “a graft, specifically a heterograft, for replacing
damaged connective tissue, including a plurality of long, thin connective
animal tissue fibers extracted from an animal tendon or ligament” (Chvapil
2:45-47).
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2. Chvapil states that the “fibers are maintained in a bundle in
generally parallel relationship to each other” (id. at 2:50-51) and illustrates
an embodiment in which bundles of fibers are arranged in a braid (id. at
3:29, Fig. 1A)
3. Chvapil discloses that “the fibers of the heterograft are arranged to
produce loops at at least one end of the heterograft, thereby allowing sutures
to be passed through the loops to anastomize the heterograft to a stump of
the damaged connective tissue” (id. at 3:12-14).
4. Chvapil discloses that “the heterograft is soaked in a source of
fibronectin and fibroblast[ ] growth factor or other drugs” (id. at 3:18).
Fibronectin and fibroblast growth factor are cell proliferation promoting
agents (id. at 13:7-8).
5. Gendler discloses that “completely or partially demineralized
cortical bone can be sliced in strips and rods and that such strips and rods . . .
have compliant elasticity and longitudinal strength similar to natural
ligaments and tendons” (Gendler, col. 4, ll. 46-51).
6. Gendler states that its “invention provides artificial ligaments
produced from demineralized cortical bone which are useful for in vivo
replacement, repair and augmentation of damaged ligaments [or] tendons”
(id. at col. 4, ll. 52-55).
Analysis
Chvapil discloses a graft, or implant, comprising a quantity of fibers
extracted from tendons or ligaments (FF 1) arranged in a braid (FF 2) and
possessing tissue healing activity (FF 4), where the fibers are configured to
produce loops at one or both ends to allow attachment to tissue via sutures
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(FF 3). Gendler discloses artificial ligaments produced from demineralized
bone (FF 6) that have elasticity and strength comparable to natural ligaments
or tendons (FF 5). We agree with the Examiner that these disclosures would
have made it obvious to substitute Gendler’s bone-derived fibers for
Chvapil’s tendon- or ligament-derived fibers, since Gendler discloses that its
fibers have properties comparable to those of natural ligaments or tendons.
Appellants argue that Chvapil teaches away from the claimed
invention, because it suggests synthetic materials as alternatives for its
tendon- or ligament-derived fibers (Appeal Br. 8-9, citing Chvapil at 13).
This argument is unpersuasive because Gendler expressly teaches that its
bone-derived fibers have properties comparable to the materials used by
Chvapil. The combination therefore would have been obvious based on the
combined references, regardless of whether Chvapil would have suggested
it.
Appellants also argue that Gendler teaches that ligament prostheses
can be braided, but does not teach that its bone-derived material can be
braided and, in fact, teaches away from braids because they can deform and
delaminate (Appeal Br. 10, citing Gendler at col. 4, ll. 8-22).
This argument is also unpersuasive. Gendler states that “[d]ue to the
undesirability of having to sacrifice one tissue and its associated function, in
order to repair another, a number of synthetic, permanent total ligament
prostheses . . . have been tried” (Gendler, col. 1, ll. 45-49, emphasis added).
Gendler discusses a number of the known synthetic prostheses (see id. at
col. 2, l. 2 to col. 3, l. 52). Gendler concludes that all of these “tissue
replacement and/or augmentation approaches suffer from various
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deficiencies” (id. at col. 3, ll. 53-55) and that the “synthetic prosthetics also
suffer from certain deficiencies” (id. at col. 3, ll. 63-64).
Among these deficiencies is “constructional deformation after
implantation and, as a result, becom[ing] too lax over time” (id. at col. 4, ll.
10-12). Another deficiency is that “as a result of the contact of yarns in
braided, woven, or meshed constructions ultimately a delamination of
carbon from these points could occur” (id. at col. 4, ll. 19-21, emphasis
added). Thus, the context of the passage relied on by Appellants makes
clear that the problems discussed by Gendler apply to prior art, synthetic
ligament prostheses, not the bone-derived fibers of Gendler’s invention.
Gendler does not provide a reason for a skilled worker to doubt that its fibers
would be operative in Chvapil’s braided implant.
Finally, Appellants argue that a person of ordinary skill in the art
would not have been motivated to combine Chvapil and Gendler (Appeal Br.
10-11). However, for the reasons discussed above, we disagree.
With regard to claims 11 and 12, Appellants argue that “there is no
teachings or suggestions of the length to thickness ratio or the length or [sic,
to] width ratio of the elongated bone elements as recited in the claims”
(Appeal Br. 11). Similarly with regard to claims 28 and 29, Appellants
argue that the Examiner has not pointed to “teachings in these two
references for the length to width ratio, or the length or [sic, to] width ratio
of the implant as recited in the claims” (id. at 11-12).
These arguments are also unpersuasive. Claims 11 and 12 require the
implant to have a “median length to median thickness ratio” of between 50:1
and 500:1 (claim 11) or between 50:1 and 100:1 (claim 12) and a “median
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length to median width ratio” of between 10:1 and 200:1 (claim 11) or
between 50:1 to 100:1 (claim 12). Claim 28 requires a length to width ratio
in the same range as claim 12. Claim 29 requires a length to thickness ratio
in the same range as claim 11.
The Examiner points out that Gendler teaches that its strips or rods
can have a length of 5 to 20 cm and both a width and thickness of 1 to 15
mm (Answer 5, citing Gendler, col. 6, l. 31 to col. 7, l. 8). These ranges
correspond to a length to thickness ratio between 20 cm:1 mm, or 200:1, and
5 cm:15 mm, or 50:15. Thus, the lower end (50:15) of Gendler’s range is
higher than that of claims 11 and 12 (50:1), while the upper end (200:1) of
Gendler’s range is lower than that of claim 11 (500:1) but higher than that of
claim 12 (100:1). Gendler thus discloses a range of length to thickness
ratios that is within the range of claims 11 and 29, and overlaps the range of
claim 12.
Similarly with length and width, the ranges disclosed by Gendler
correspond to length to width ratios between 200:1 and 50:15. This range of
ratios is within the range recited in claim 11 and overlaps the range recited
in claims 12 and 28. Gendler’s disclosed values for length, width, and
thickness therefore support a prima facie case of obviousness for the ratios
recited in claims 11, 12, 28, and 29. See In re Peterson, 315 F.3d 1325,
1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists
when the ranges of a claimed composition overlap the ranges disclosed in
the prior art.”); id. at 1329-30 (“Selecting a narrow range from within a
somewhat broader range disclosed in a prior art reference is no less obvious
than identifying a range that simply overlaps a disclosed range.”).
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Conclusion of Law
A preponderance of the evidence supports the Examiner’s conclusion
that it would have been obvious to use Gendler’s bone-derived fibers in
Chvapil’s implant, and that the references would have suggested the ratios
required by claims 11, 12, 28, and 29.
Claims 2-7, 9, 10, 14, 15, 20, 22-25, 27, 30, and 31 were not argued
separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
II.
The Examiner has rejected claims 8, 13, 16, and 17 as obvious based
on Chvapil, Gendler, and Boyce (Answer 6).
With respect to claims 8, 16, and 17, Appellants present no additional
argument based on the teachings of Boyce, and rely on the same arguments
addressed above with regard to Chvapil and Gendler (see Appeal Br. 12).
For the reasons discussed above, therefore, we affirm the rejection of claims
8, 16, and 17.
With respect to claim 13, Appellants argue that none of the cited
references “teaches or suggests that the elongated elements in the form of
threads are assembled into yarns and the yarns are assembled into a braid as
claimed” (Appeal Br. 12).
We agree with Appellants that the Examiner has not pointed to
evidence or provided sound technical reasoning to show that the limitation
recited in claim 13 would have been obvious based on the cited references.
The Examiner acknowledges that “Chvapil as modified by Gendler fails to
disclose . . . making yarns” with the disclosed fibers (Answer 6). The
Examiner finds that “Boyce teaches that it was known to bond adjacent
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elements together and to utilize bioresorbable synthetic materials, such as
hydroxyapatite, in similar implants; see page 8, line 9 to page 13, line 22”
(id.). The Examiner concludes that “it would have been prima facie obvious
to do the same in the Chvapil device for the same reasons that Boyce does
the same” (id.).
The Examiner, however, has not pointed to any disclosure in Boyce of
forming yarns from fibers like those of Chvapil and Gendler. The Examiner
therefore has not provided an adequate basis for concluding that claim 13
would have been prima facie obvious based on the cited references.
SUMMARY
We affirm the rejection of claims 1-7, 9-12, 14, 15, 20, 22-25, and 27-
31 under 35 U.S.C. § 103(a) based on Chvapil and Gendler.
We affirm the rejection of claims 8, 16, and 17 under 35 U.S.C.
§ 103(a) based on Chvapil, Gendler, and Boyce.
We reverse the rejection of claim 13.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART

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