Ex Parte Livesey et al

Patent Trial and Appeal Board

Sep 17, 2012

10273780 (P.T.A.B. Sep. 17, 2012)

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.
10/273,780 10/18/2002 Stephen A. Livesey STR.0307US 2913
84398 7590 09/17/2012
Finnegan/KCI
901 New York Avenue, NW
Washington, DC 20001
EXAMINER
POPA, ILEANA
ART UNIT PAPER NUMBER
1633
MAIL DATE DELIVERY MODE
09/17/2012 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 STEPHEN A. LIVESEY, DAVID J. MCQUILLAN,
HERBERT DANIEL BENIKER, LAWRENCE E. BOERBOOM,
and WARREN O. HAGGARD
____________

Appeal 2011-009953
Application 10/273,780
Technology Center 1600
____________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
LORA M. GREEN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1, 8-10, 14, and
36-44 (App. Br. 6). We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a method of treatment. Claims 1 and 14 are
representative and are reproduced in the Claims Appendix of Appellants’
Brief.

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Claims 1, 8-10, 14, and 39-44 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Bilbo,1 Fowler,2 and Suckow.3
Claims 1, 8-10, 14, and 36-44 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Bilbo, Fowler, Suckow, Bonadio,4
and Seandel.5
Claims 1, 8-10, 14, and 36-44 stand provisionally rejected under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims 1, 2, 4, 5, 17, 18, 22, and 25-28 of copending
Application No. 12/883,515.
We affirm the obviousness rejections under 35 U.S.C. § 103(a).
Appellants do not contest the provisional obviousness-type double
patenting rejection (see App. Br. 11). Therefore, the provisional rejection is
summarily affirmed and will not be further addressed. See MANUAL OF
PATENT EXAMINING PROCEDURE § 1205.02 (“If a ground of rejection
stated by the examiner is not addressed in the appellant's brief, that ground
of rejection will be summarily sustained by the Board.”).

1 Bilbo, US 2002/0103542 A1, published August 1, 2002.
2 Edward B. Fowler, et al., Ridge Preservation Utilizing an Acellular
Dermal Allograft and Demineralized Freeze-Dried Bone Allograft: Part II.
Immediate Endosseous Implant Placement, 71(8) J. PERIODONTOL 1360-
1364 (2000).
3 M.A. Suckow, DVM, Enhanced Bone Regeneration Using Porcine Small
Intestinal Submucosa, 12 J. INVESTIGATIVE SURGERY 277-287 (1999).
4 Bonadio, et al., US 5,942,496, issued August 24, 1999.
5 M. Seandel, et al., Growth factor-induced angiogenesis in vivo requires
specific cleavage of fibrillar type I collagen, 97(8) BLOOD 2323-32 (2001)
(PubMed Abst. only).
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Obviousness:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?

FACTUAL FINDINGS (FF)
FF 1. Bilbo suggests a method for the repair of damaged organ or tissue,
including bone and periosteum, in a mammalian patient (Ans. 6-7; Bilbo 8:
¶ [0056] and Abstract).
FF 2. Bilbo’s method comprises “placing non-particulate acellular collagen
matrices derived from donor collagen-based tissues or organs [e.g., the
acellular layer of porcine intestinal collagen (i.e., small intestinal submucosa
or SIS) or … human dermis-derived AlloDerm] in or on the recipient organs
or tissues,” wherein “the recipient tissue could be periosteum . . . or bone”
(Ans. 6-7).
FF 3. Bilbo suggests that the donor may be a human or porcine donor
source, wherein porcine “is the preferred source” (see generally Ans. 6-7;
Bilbo 2: ¶ [0013]).
FF 4. Bilbo suggests “that the acellular matrices could comprise a growth
factor … are capable … [of] promot[ing] cell adhesion … and proliferation
… and that, upon implantation, these matrices are repopulated via the
ingrowth of host cells” (Ans. 7; Bilbo 1: ¶ [0003], 3: ¶ [0017], 8: ¶ [0052],
and 8-9: ¶ [0059]).
FF 5. Examiner finds that Bilbo fails to suggest the treatment of “defects in
a long bone having a periosteal defect” (Ans. 7).
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FF 6. Suckow suggests the repair of “critical gaps in long bones having
periosteal defects by implanting non-particulate SIS into the gap” (id.; see
also Suckow 285: col. 2, ll. 17-22 (“In summary, porcine small intestinal
submucosa facilitates rapid filling of a long-bone defect in rats. The
presence of cellular marrow in SIS-treated rats suggests that SIS may
facilitate recruitment and seeding of newly formed bone with cellular
elements typical of mature bone”)).
FF 7. Suckow suggests that defects “filled with … SIS demonstrated
partial filling of the defect as early as 3 weeks after implantation” and that
“[f]illing was significantly greater at 6 weeks … and at 12 and 24 weeks …
than a 3 weeks” (Suckow 279: col. 2, ll. 10-12 and 284: col. 1, ll. 6-9).
FF 8. Appellants’ Specification discloses that particulates “generally
hav[e] a particle size of about 1 micron to about 900 microns, about 30
microns to about 750 microns, or about 150 to about 300 microns” (Spec.
12: 11-13). In this regard, Appellants’ Specification distinguishes between
“pieces” and “particulates” (see Spec. 7: 1-3 (“a matrix derived from a heart
valve can be provided as a whole valve, as small sheets or strips, as pieces
cut into any of a variety of shapes and/or sizes, or in a particulate form”
(emphasis added)).
FF 9. Examiner finds that Fowler suggests “that AlloDerm is suitable to be
used in humans for bone regeneration” (Ans. 8).
FF 10. Examiner finds that the combination of Bilbo, Suckow, and Fowler
does “not specifically teach … [the use of] AlloDerm to repair periosteum
associated with [a] critical gap defect,” but nonetheless, finds that “Bilbo
teaches that practically any non-particulate acellular collagen matrix is
suitable to repair periosteum” (id.).
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FF 11. Zhao6 suggests that “[a]ll the prepared implants were wrapped snug
around the ends of the bone defect” (Zhao 59: col. 2, ll. 36-37).
FF 12. Zhao suggests that at “4 weeks after the implantation operation …
[t]he segmental bond defect treated with SIS is empty under X-ray
detection” (Zhao 62: col. 2, Fig. 6 legend).

ANALYSIS
The combination of Bilbo, Fowler, and Suckow:
Appellants provide separate arguments for the following groups of
claims: (I) claims 1, 8-10, 39-40, and 42-44 and (II) claims 14 and 41.
Claims 1 and 14 are representative. 37 C.F.R. § 41.37(c)(1)(vii).
Based on the combination of Bilbo, Fowler, and Suckow Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious to (i) “apply Bilbo’s SIS to a long bone having a
critical gap and a periosteal defect to achieve the predictable result of
treating the bone,” (b) “replace the porcine SIS with AlloDerm when
treating bone defects in humans,” and (c) “implant AlloDerm on the
periosteal defect associated with the critical gap defect in the human long
bone … to achieve the predictable result of repairing the damaged human
periosteum” (Ans. 7-8).

6 Lin Zhao, et al., The study of the feasibility of segmental bone defect repair
with tissue- engineered bone membrane: a qualitative observation, 3 STRAT
TRAUM LIMB RECON 57-64 (2008).
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Claim 1:
Appellants contend that while “Bilbo discusses a variety of different
acellular tissue matrices and a long list of possible treatment sites … Bilbo
provides no guidance as to what type of tissue matrices would be successful
in treating such defects in bone” (App. Br. 13; Reply Br. 4). We are not
persuaded (see Ans. 10 (“By reading Bilbo, one of [ordinary] skill in the art
would have concluded that the acellular collagen matrices are equivalent in
their repairing capabilities and would [have] found it obvious to select any
of them for repairing a defect in any target tissue/organ of interest,”
including bone and periosteum); see also FF 1-2). Appellants provide no
persuasive evidence or reasoning to support a conclusion that Bilbo’s
suggestion to use SIS or AlloDerm to treat bone is not a suggestion that SIS
or AlloDerm are functionally equivalent materials for the treatment of bone
(see Reply Br. 4; Cf. Ans. 10).
Since Bilbo suggests the treatment of periosteum, we are not
persuaded by Appellants’ contentions regarding periosteum (App. Br. 14-16;
Cf. FF 1-2).
Claim 1 does not require “wrapping a[] defect” (see Claim 1).
Therefore, we are not persuaded by Appellants’ contention that “Suckow
never describes wrapping any defect” (App. Br. 14).
Bilbo suggests source tissue that can be used to treat bone or
periosteum (FF 1-3). Accordingly, we are not persuaded by Appellants’
contention to the contrary (App. Br. 17; see also Ans. 11). For the same
reason we are not persuaded by Appellants’ contention that Bilbo “never
provides any example or discussion of … treating bone using dermis or any
other tissue” (id.; Reply Br. 7; Cf. Ans. 11). In re Mills, 470 F.2d 649, 651
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(CCPA 1972) (“All the disclosures in a reference must be evaluated … a
reference is not limited to the disclosure of specific working examples.”).

Claim 14:
Appellants contend that the treatment of gap defects is unpredictable
in this art and “was only achieved by pre-seeding the … [matrix] with cells
(as done by Zhao) or completely filling the defects with particulate material
(as done by Suckow)” (Reply Br. 5; see also App. Br. 18). We are not
persuaded.
Examiner relies on Suckow to establish that non-particulate materials
are useful in treating gap defects in bone (FF 6). According to Appellants’
Specification particulate materials have a size range of “about 1 micron to
about 900 microns” (FF 8; see also App. Br. 20). In addition, Appellants’
Specification distinguishes between pieces of tissue and particulates (id.).
Accordingly, we are not persuaded by Appellants’ contention that Suckow’s
“‘[m]inced 1mm x 1mm tissue are particulates” (App. Br. 20; see also id. at
22; Reply Br. 5-6; see also Ans. 15).7 In sum, notwithstanding Appellants’
contention to the contrary, Suckow suggests the use of non-particulate
material.
Given Appellants’ recognition that Suckow suggests the treatment of
gap defects in bone, we are not persuaded by Appellants’ contentions
regarding Zhao (see e.g., Reply Br. 5; id. at 7 (“successful treatment of long
bone gap defects using small intestine submucosa … was only achieved [in
Suckow] by completely filling the defects with minced particles” (emphasis
added))). In addition, Appellants’ inference regarding Zhao is based on

7 For clarity, one micron is 0.001 millimeter (mm).
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Zhao’s figure 6, which is an x-ray taken 4 weeks after the repair operation
(FF 12; Cf. App. Br. 17-18). Suckow, which Appellants recognize as a
successful treatment of bone, suggested only partial repair after 3 weeks,
with “significantly greater [filling] at 6 weeks … and at 12 and 24 weeks …
than at 3 weeks” (FF 7; Ans. 13-14). Accordingly, the inference Appellants’
draw from Zhao is based on a time frame that precedes the time period that
those of ordinary skill in this art would have recognized as the time period
where significant bone repair occurs (FF 12; Cf. FF 7). Therefore, we are
not persuaded by Appellants’ contention that Zhao suggests some level of
unpredictability in the art (App. Br. 15).
Claim 14 does not require wrapping or the treatment of long bones
(see Claim 14; see also Ans. 13). Accordingly, we are not persuaded by
Appellants’ contention that Suckow fails to suggest “wrapping a bone”
(App. Br. 19; Cf. FF 6 (Suckow suggests the repair of “critical gaps in long
bones having periosteal defects by implanting non-particulate SIS into the
gap”) (emphasis added)). In addition, this further undermines Appellants’
reliance on Zhao, wherein all the implants in Zhao were wrapped around the
ends of the bone defect (FF 11; Ans. 13 (“the teachings of Zhao et al., drawn
only to wrapping the bone gap … are not material to the instant rejection”)).
In this regard, we recognize Examiner’s “note that there is no teaching in
Zhao et al. indicating that filling the bone defect in the absence of pre-
seeded cells would not be successful” (Ans. 13).
Since Suckow is not relied upon in isolation, we are not persuaded by
Appellants’ contention that “one skilled in the art would not understand,
based on Suckow, that dermal matrices could be predictably used to treat
periosteal defects given the unpredictability in the art” (App. Br. 20). Bilbo
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suggests the use of dermal or SIS matrices (see FF 2). Appellants
acknowledge Suckow’s successful use of SIS to treat bone defects (see e.g.,
Reply Br. 7). Appellants fail to provide persuasive reasoning or evidence to
establish that a person of ordinary skill in this art would not have reasonably
considered the use of a dermal matrix, as suggested by Bilbo, to fill critical
gaps, as suggested by Suckow, would have yielded the predictable result of
successfully treating the bone defect (see generally Ans. 11-12). See KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of
familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results.”).
We are not persuaded by Appellants’ contention that Suckow obtained
“limited success” and suggested that “[a]dditional studies will be needed to
further. . . . evaluate the potential applications of SIS as a bone graft
substitute” (App. Br. 20 (alteration original); see also App. Br. 22-23).
Notwithstanding Appellants’ contention to the contrary, Suckow expressly
states “[i]n summary, porcine small intestinal submucosa facilitates rapid
filling of a long-bone defect in rats. The presence of cellular marrow in SIS-
treated rates suggests that SIS may facilitate recruitment and seeding of
newly formed bone with cellular elements typical of mature bone” (FF 6).
Bilbo suggests the use of SIS or AlloDerm to treat bone defects
including periosteal defects (FF 1-5). Fowler suggests that AlloDerm is
suitable for use in humans (FF 9). Suckow suggests treatment of a critical
gap defect of bone with SIS (FF 6). Taken together, we find no error in
Examiner’s reasoning that while the combination of Bilbo, Suckow, and
Fowler does “not specifically teach … [the use of] AlloDerm to repair
periosteum associated with [a] critical gap defect”, “Bilbo teaches that
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practically any non-particulate acellular collagen matrix[, such as SIS or
AlloDerm] is suitable to repair periosteum” (FF 10). Because Fowler is not
relied upon in isolation, we are not persuaded by Appellants’ contention that
“Fowler cannot suggest that Allo[D]erm could be used for successful
treatment of periosteal gap defects or any defect in long bones because
Fowler does not treat any of those types of defects” (App. Br. 21 (emphasis
added); Reply Br. 8; Cf. Ans. 19-20). For the same reasons we are not
persuaded by Appellants’ contention that Fowler used AlloDerm as a
“barrier membrane” (id. at 22).

The combination of Bilbo, Fowler, Suckow, Bonadio, and Seandel:
Appellants contend that Bonadio and Seandel fail to make up for the
deficiencies in the combination of Bilbo, Fowler, and Suckow (App. Br. 23).
Having found no deficiency in the combination of Bilbo, Fowler, and
Suckow, we are not persuaded by Appellants’ contention (see Ans. 20).

CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness.
The rejection of claims 1 and 14 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Bilbo, Fowler, and Suckow is
affirmed. Claims 8-10, 39-40, and 42-44 fall with claim 1. Claim 41 falls
with claim 14. 37 C.F.R. § 41.37(c)(1)(vii).
The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Bilbo, Fowler, Suckow, Bonadio, and Seandel is
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affirmed. Because they are not separately argued claims 8-10, 14, and 36-44
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

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

cdc