Ex Parte Koob et al

Patent Trial and Appeal Board

Aug 18, 2016

11964756 (P.T.A.B. Aug. 18, 2016)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/964,756 12/27/2007 Thomas J. Koob 9624-6 2350
20792 7590 08/19/2016
MYERS BIGEL & SIBLEY, P.A.
PO BOX 37428
RALEIGH, NC 27627
EXAMINER
SHARMA, YASHITA
ART UNIT PAPER NUMBER
3774
MAIL DATE DELIVERY MODE
08/19/2016 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte THOMAS J. KOOB, DOUGLAS PRINGLE, and
DANIEL HERNANDEZ
____________

Appeal 2014-003762
Application 11/964,756
Technology Center 3700
____________

Before CHARLES N. GREENHUT, LISA M. GUIJT, and
GORDON D. KINDER, Administrative Patent Judges.

GUIJT, Administrative Patent Judge.
DECISION ON APPEAL

STATEMENT OF THE CASE
Appellants1 seek our review under 35 U.S.C. § 134 of the Examiner’s
decision2 rejecting claims 12–21, 24, 26, 33, and 35–53 under 35 U.S.C. § 103(a).
We have jurisdiction under 35 U.S.C. § 6(b).

1 Appellants identify the real party in interest as Shriners Hospitals for Children.
App. Br. 2.
2 Appeal is taken from the Final Office Action dated March 12, 2013 (“Final
Act.”).
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Application 11/964,756
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We REVERSE and enter NEW GROUNDS OF REJECTION pursuant to
37 C.F.R. § 41.50(b).
CLAIMED SUBJECT MATTER
Claims 12, 16, 24, 26, 35, and 42 are the independent claims on appeal.
Claim 12, reproduced below, is illustrative of the claimed subject matter on appeal.
12. A biomedical implant, comprising:
at least one high-strength NDGA polymerized collagen fiber
such that the at least one high-strength fiber has an average tensile
strength of at least 150 MPa.

REJECTIONS
1. Claims 12–15, 33, 35–38, and 51 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Koob (US 6,565,960 B2; iss. May 20,
2003), Silver (US 5,171,273; iss. Dec. 15, 1992), and Shinoda (US 6,090,910; iss.
July 18, 2000).3
2. Claims 16–21, 24, 26, 39–50, 52, and 53 stand rejected under 35
U.S.C. § 103(a) as unpatentable over Koob, Silver, Shinoda, and Hunt (US
4,590,928; iss. May 27, 1986).

3 Although claim 51 is omitted from the listing of the claims subject to this
rejection, the Examiner provides factual findings and reasoning for rejecting claim
51. Final Act. 4–5. Further, although claims 43–46 are included in the listing of
claims subject to this rejection, claims 43–46 depend from independent claim 42,
which is subject to Rejection 2, which includes an additional prior art reference,
Hunt. Applying only three references to reject the narrower, dependent claims,
while applying four references to reject the broader independent claim is
inconsistent with the principle that “[c]laims in dependent form shall be construed
to include all the limitations of the claim incorporated by reference into the
dependent claim.” 37 C.F.R. § 1.75. Therefore, we treat claims 43–46 as subject
to Rejection 2.
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Application 11/964,756
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ANALYSIS
Rejection 1
Regarding independent claims 12 and 35, the Examiner finds, inter alia, that
Koob discloses “synthetic NDGA polymerized collagen fibers” with “a tensile
strength of at least 80 MPa.” Final Act. 4 (citing Koob, col. 5, ll. 6–11, col. 14, ll.
24–26). The Examiner determines that Koob fails to disclose “high strength fibers
having an average tensile strength of at least about 150 MPA [or] 279 MPa . . . ;
and wherein at least some of the fibers have a dry diameter of about 0.08 mm (80
µm), on average.” Id.
The Examiner relies on Silver for teaching “a similar invention comprising
high strength collagen fibers that are increased in tensile strength by being air dried
under tension.” Id. at 4–5 (citing Silver, col. 8, ll. 45–48 (“The fibers are then
rinsed in distilled water and air dried under tension.”)). Examiner also relies on
Silver for teaching fibers that have a dry diameter of about 0.08 mm. Id. (citing
Silver, col. 7, ll. 3–4 (“The graft material comprises collagen fibers with a diameter
around the range of about 20–60 microns.4”)). The Examiner reasons that it would
have been obvious
to modify the NDGA polymerized collagen fibers in Koob to be air
dried while held under tension and modify the diameter to be about 0.08
mm . . . , as taught and suggested by Silver, for the purpose of creating
strong fibers that can assume [a] variety of elasticities and degrees of
stiffness and enhance the deposition of repair tissue in tendons and
ligaments.
Id. at 5 (citing Silver, col. 4, ll. 13–22).
The Examiner relies on Shinoda, inter alia, for disclosing a stretched
implantable monofilament “having a tensile strength of 150 MPa [and] 279 MPa.”

4 20 microns = 0.02 mm; 60 microns = 0.06 mm
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Id. (citing Shinoda col. 20, ll. 3–13, col. 20, ll. 57–58). The Examiner reasons that
it would have been obvious to modify Koob’s NDGA polymerized collagen fibers,
as modified by Silver’s stretching and air drying under tension to a diameter of
about 0.08 mm, to have an average tensile strength of at least about 150 MPa or
279 MPa, as taught by Shinoda, “for the purpose of having high strength fibers
with excellent line[a]r tensile strength and flexibility to allow for ligature
stability.” Id. (citing Shinoda, col. 1, ll. 6–11).
Appellants argue, inter alia, that one of ordinary skill in the art would not
have been led to combine Silver with Koob, as proposed by the Examiner, because
Silver and Koob “describe different collagen fiber materials.” App. Br. 6. In
particular, Appellants submit that
Silver is directed to grafts containing reconstituted crosslinked collagen
fibers that are prepared from insoluble type I collagen. . . . In contrast,
Koob describes polymeric materials, such as collagen fibers, that can
have an increased tensile strength when a catechol-containing
monomer, such as NDGA, intercalates into the collagen.
Id. (citing Silver col., 3, ll. 17–21, col. 8, ll. 18–56; Koob, col. 1, ll. 30–43).
Appellants further argue that “Silver describes that in their process their fibers are
‘air dried under tension’, but makes no suggestion that it is this step that increases
tensile strength,” but rather “teaches that adding a high molecular weight
chondroitin sulfate proteoglycan to their collagen fibers during their synthesis
enhances ultimate tensile strength.” Id. at 7–8 (citing Silver, col. 3, ll. 47–52, col.
8, ll. 47–48); see also Reply Br. 2 (“Nor does Silver teach or suggest that this
specific part of their method would strengthen the claimed NDGA collagen
fibers.”) (citing Silver, col. 9, ll. 30–32). Appellants conclude that one of ordinary
skill in the art “would have had no apparent reason to combine the NDGA
polymerized fibers of Koob with an isolated step in the method of Silver,
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Application 11/964,756
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particularly as this isolated step is not suggested to increase tensile strength and the
fibers of Silver are not stronger than those of Koob.” App. Br. 8. Appellants also
conclude that “[a] hindsight comparison selecting isolated features from references
directed to different collagen fiber materials is the only way in which such a
combination of references could be combined to arguably arrive at the claimed
invention, which is improper.” App. Br. 7.
We are persuaded by Appellants’ arguments. Although Silver discloses
making small diameter collagen fibers, Appellants are correct that the step of air
drying under tension is one step in a process disclosed in Silver for preparing
collagenous fibrous material or collagen fibers and that Silver is silent with respect
to any specific benefits attributed to such a step. See, e.g., Silver, col. 3, ll. 37–39,
col. 8, l. 18–43, Examples I–III. In addition, the Examiner does not provide
rationale for reasoning that the step of air drying under tension in Silver’s process
for preparing collagenous fibrous material or collagen fibers is applicable to
Koob’s polymers formed from NDGA. Thus, the Examiner’s combination appears
to be the result of impermissible hindsight. We also agree with Appellants that the
Examiner’s reliance on Shinoda does not cure the deficiency in the Examiner’s
findings and reasoning with respect to Silver, in that “Shinoda is only relied on for
the teachings of a specific tensile strength” and “Shinoda is not directed to fibers
similar to Koob or Silver.” Reply Br. 4 (see also App. Br. 8 (“the monofilament of
Shinoda is not a collagen fiber”)).
Accordingly, we do not sustain the Examiner’s rejection of independent
claims 12 and 35, and claims 13–15, 33, 36–38, and 51.
Rejection 2
Independent claim 16 recites, in relevant part, “a high-strength NDGA
collagen fiber flexible construct.” App. Br. 17 (Claims App.). Appellants’
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Specification states that “[t]he term ‘high-strength’ refers to fibers having an
average tensile strength of at least about 150 MPa, such as between about 180 MPa
and 350 MPa, and typically, for bovine, porcine or caprine based ‘donor’ collagen,
between about 180 MPa and 280 MPa, such as about 279 MPa (measured on
average).” Spec. ¶ 34. Therefore, claim 16 requires the NDGA collagen fiber
flexible construct to have an average tensile strength of at least about 150 MPa.
Because the Examiner relies on the same findings and reasoning for this limitation
as the Examiner relied on for the limitation of “[a] high-strength fiber [having] an
average tensile strength of at least about 150 MPa” in independent claim 12, and
because Hunt does not cure the deficiencies in the Examiner’s findings and
reasoning as discussed supra,5 we also do not sustain the Examiner’s rejection of
independent claim 16 and claims 17–21 depending therefrom.
Independent claims 24, 26, and 42 recite, in relevant part, a device
comprising high-strength NDGA collagen fibers or an NDGA collagen fiber
flexible construct, wherein the fibers or NDGA fiber construct have a tensile
strength between “about 180 MPa and 280 MPa” (claims 24 and 26) or “about 180
MPa and 300 MPa” (claim 42). App. Br. 18, 20 (Claims App.). Because the
Examiner relies on the same findings and reasoning for these limitations as the
Examiner relied on for the limitation of “[a] high-strength fiber [having] an
average tensile strength of at least about 150 MPa” in independent claim 12, and
because Hunt does not cure the deficiencies in the Examiner’s findings and
reasoning as discussed supra, we also do not sustain the Examiner’s rejection of
independent claims 24, 26, and 42, and claims 43–50, 52, and 53 depending
therefrom. In addition, because we do not sustain the Examiner’s rejection of

5 The Examiner relies on Hunt for disclosing a medical kit for ligament repair
having a sterile packaging. Final Act. 6.
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independent claim 35 as discussed supra, we also do not sustain the Examiner’s
instant rejection of claims 39–41 depending therefrom.
NEW GROUND OF REJECTION
Pursuant to our authority under 37 C.F.R. § 41.50(b), we enter a new ground
of rejection under 35 U.S.C. § 112, second paragraph, against dependent claims 13,
14, 36, and 37. Independent claim 12 recites “[a] biomedical implant.” App. Br.
17 (Claims App.). Claims 13 and 14, which depend from claim 12, further recite a
“bioprosthesis.” Id. The Specification distinguishes between “some embodiments
[that] form[] a bioprosthesis” and “[s]till other embodiments . . . directed to
biomedical implants.” Spec. ¶¶ 6–7. Thus, there is a lack of antecedent basis for
the claim term “bioprosthesis” in claims 13 and 14 that causes these claims to be
indefinite. Claims 36 and 37 suffer from the same deficiency.

DECISION
The Examiner’s decisions to reject claims 12–21, 24, 26, 33, and 35–53
under 35 U.S.C. § 103(a) are REVERSED.
We find claims 13, 14, 36, and 37 indefinite under 35 U.S.C. § 112, second
paragraph.

FINALITY OF DECISION
This decision contains a new ground of rejection pursuant to 37 C.F.R. §
41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to
this paragraph shall not be considered final for judicial review.” 37 C.F.R. §
41.50(b) also provides: When the Board enters such a non-final decision, the
appellant, within two months from the date of the decision, must exercise one of
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Application 11/964,756
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the following two options with respect to the new ground of rejection to avoid
termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the claims so
rejected or new Evidence relating to the claims so rejected, or both, and have the
matter reconsidered by the Examiner in which event the prosecution will be
remanded to the Examiner. The new ground of rejection is binding upon the
examiner unless an amendment or new Evidence not previously of Record is made
which, in the opinion of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims, appellant may
again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be reheard under §
41.52 by the Board upon the same Record. The request for rehearing must address
any new ground of rejection and state with particularity the points believed to have
been misapprehended or overlooked in entering the new ground of rejection and
also state all other grounds upon which rehearing is sought.
Further guidance on responding to a new ground of rejection can be found in
the Manual of Patent Examining Procedure § 1214.01.

REVERSED; 37 C.F.R. § 41.50(b)