Ex Parte Kemp et al

Patent Trial and Appeal Board

Jun 17, 2016

10589227 (P.T.A.B. Jun. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/589,227 0710212007
32425 7590 06/21/2016
NORTON ROSE FULBRIGHT US LLP
98 SAN JACINTO BOULEVARD
SUITE 1100
AUSTIN, TX 78701-4255
FIRST NAMED INVENTOR
Paul Kemp
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.
DFBP:075US/l 1001662 5775
EXAMINER
EPPS -SMITH, JANET L
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
06/21/2016 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):
aoipdocket@nortonrosefulbright.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAUL KEMP, GYORGYI TALAS,
JENNIFER SUTHERLAND, MARGARET BATTEN,
PENELOPE ANN JOHNSON, ANDREW SHERING,
and MICHAEL MCWHAN
Appeal2013-009151
Application 10/589,227
Technology Center 1600
Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a wound
healing composition. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We reverse.
1 Appellants identify the Real Party in Interest as Smith & Nephew, Inc. (see
App. Br. 1).
Appeal2013-009151
Application 10/589,227
Statement of the Case
Background
"Autologous skin-grafting has been used to close open wounds,
minimise the risk of opportunistic infection, accelerate healing and minimise
scarring. Skin grafting has significant limitations" (Spec. 4:6-9). "More
recently, tissue-engineering solutions have become available ... Tissue
equivalents may be dermal equivalents or total skin equivalents, with the
aim being to provide effective coverage of the wound as quickly as possible"
(Spec. 4: 18-26).
The Claims
Claims 1, 4, 8-10, 13-15, 17-19, 23-28, 39--42, 44, 46, 48-51 and
63---65 are on appeal. 2 Independent claim 1 is representative and reads as
follows:
1. A wound healing composition comprising living human
dermal fibroblast cells suspended \vithin a single-layered
sterile, non-pyrogenic, solid or semi-solid, support matrix, said
support matrix comprising a protein concentration of 3 to 12
mg.m1-1 and a cell density of said human dermal fibroblasts of
450 to 2500 cells per mm2, said composition having been
incubated for 16 to 24 hat about 37°C.
The Issue
The Examiner rejected claims 1, 4, 8-10, 13-15, 17-19, 23-28, 39-
42, 44, 46, 48-51and63---65 under 35 U.S.C. § 103(a) as obvious over
Leek,3 Herlyn,4 Drohan,5 Harichian,6 and Bilbo7 (Ans. 4--9).
2 Claims 66-71 were withdrawn (Ans. 2).
3 Leek et al., WO 02/072113 Al, published Sep. 19, 2002.
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Application 10/589,227
The Examiner finds that Leek teaches compositions "comprising cells
having a wound healing phenotype, wherein the cells are fibroblast, and
wherein cells are in a matrix-forming cell delivery vehicle" (Ans. 6). The
Examiner acknowledges that Leek does "not specifically teach wherein the
living cells are single-layered, or non-pyrogenic [or] wherein the fibroblast
are dermal fibroblast" (id.).
The Examiner finds that Herlyn teaches "a composition comprising a
matrix containing a mono layer of human dermal fibroblast" (id.). The
Examiner finds that Bilbo teaches "a biocompatible prosthesis .. .
Biocompatible means that the prostheses of the invention are ... non-
pyrogenic" (Ans. 7). The Examiner finds that Bilbo also teaches "a single
layer graft prosthesis ... Human fibroblast cell strains can be derived from a
number of sources, including ... dermis" (id.). The Examiner finds it
obvious "to modify the teachings of Leek et al. with the teachings of the
supporting references since the compositions disclosed in each reference are
disclosed as useful in the treatment of various disorders associated with the
skin, particularly in wound healing" (Ans. 8) and cites to In re Kerkhoven,
626 F.2d 846 (CCPA 1980).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner's conclusion that Leek, Herlyn, Drohan, Harichian,
and Bilbo render claim 1 obvious?
4 Herlyn et al., US 2004/0031067 Al, published Feb. 12, 2004.
5 Drohan et al., US 7,196,054 Bl, issued Mar. 27, 2007.
6 Harichian et al., US 2002/0018757 Al, published Feb. 14, 2002.
7 Bilbo, US 2002/0103542 Al, published Aug. 1, 2002.
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Application 10/589,227
Findings of Fact
1. Leek teaches:
a composition comprising cells capable of reducing an
inflammatory response caused by skin wounding and a cell
delivery vehicle capable of delivering and maintaining the cells
within a skin wound, wherein the cells are fibroblasts, the cell
delivery vehicle is a matrix-forming material, and the
composition is substantially free of other cell types, for use in
the reduction of fibrosis and scar tissue during skin wound
healing.
(Leek 3:11-18).
2. Leek teaches that "the scaffold or matrix may be formed around
the cells either in situ or prior to application of the composition to the
wound" (Leek 4:4--7).
3. Leek teaches that "[e]ach construct was cast with 500,000 cells
in a final volume of 500 ml. The desired number of cells were resuspended
in 450ml of a 7.5mg/ml fibrinogen" (Leek 8:27-29).
4. Leek teaches that "[b ]oth excisional and incisional wounds (in
Yorkshire pigs) made by standard methods to those skilled in the art were
treated with the construct on Day 0 (day of wound) and day 4 ( 4 days post-
wound)" (Leek 9:5-8).
5. Herlyn teaches
making a reconstruct comprising a human microvascular
endothelial cell (HMVEC) layer which, unlike other known
models, was not mixed within a supporting matrix or seeded
over it. Instead, the HMVEC were grown as a monolayer and
placed underneath the supporting matrix. The supporting matrix
contains human dermal fibroblasts and collagen. In a preferred
embodiment, the matrix also contains smooth muscle cells. The
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Application 10/589,227
fibroblasts, smooth muscle cells, and endothelial cells are
grown separately prior to assembly.
(Herlyn i-f 39).
6. Drohan teaches
supplemented and unsupplemented tissue sealants as well as
methods for their production and use thereof. Disclosed are
tissue sealants supplemented with at least one antimicrobial
composition. The composition may be further supplemented
with, for example, one or more antibodies, analgesics,
anticoagulants, antiproliferatives, anti-inflammatory
compounds, cytokines, cytotoxins, drugs, growth factors,
interferons, honnones, lipids, demineralized bone or bone
morphogenetic proteins, cartilage inducing factors,
oligonucleotides polymers, polysaccharides, polypeptides,
protease inhibitors, vasoconstrictors or vasodilators, vitamins,
minerals, stabilizers and the like.
(Drohan, abstract).
7. Harichian teaches that "[n]eonatal human dermal fibroblasts ...
were seeded at a density of about 7 ,500/well ... Cells were then grown to
confluence for 2 days ... each well dosed with 200 µl of a solution of gum
mastic ... the gum mastic/control solution was again removed and stored
over the weekend at 4° C. with protease inhibitor (Aprotinin from Sigma)"
(Harichian i-f 74).
8. Bilbo teaches "tissue engineered prostheses made from
processed tissue matrices derived from native tissues that are biocompatible
with the patient or host in which they are implanted" (Bilbo i-f 10).
9. Bilbo teaches that the "processed tissue matrix is used as a
single layer graft prosthesis" (Bilbo i-f 16).
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Application 10/589,227
10. Bilbo teaches that "[b ]oth single and multilayer ICL materials
may be used as a wound covering or dressing to assist in wound repair"
(Bilbo ii 42).
11. Bilbo teaches that "[m]ore preferred cell types are fibroblasts,
stromal cells, and other supporting connective tissue cells, or human dermal
fibroblasts" (Bilbo ii 53).
Principles of Law
"Inherency ... may not be established by probabilities or possibilities.
The mere fact that a certain thing may result from a given set of
circumstances is not sufficient." MEHL/Biophile Int 'l. Corp. v. Milgraum,
192 F.3d 1362, 1365 (Fed. Cir. 1999).
Analysis
Appellants contend that the "claimed composition has particular
features (including sterility and specified protein concentrations and human
dermal fibroblast densities) that are present in the composition after 'having
been incubated for 16 to 24 hat about 37°C'"(App. Br. 3-4). Appellants
contend that the "one of ordinary skill in the art would presume that the
claimed composition would not be sterile after incubation at a wound site"
(App. Br. 4).
The Examiner finds that the "limitation 'having been incubated' is
very broad and there is no way for the ordinary skilled artisan to ascertain
when this incubation occurred" (Ans. 11 ). The Examiner finds that
"[ m ]oreover, the instant claims are drawn to a composition and not to a
method for producing a composition having a wound healing phenotype"
(Ans. 11).
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Application 10/589,227
While we agree8 with the Examiner's position that claim 1, read in
light of the Specification, might reasonably have been read on incubation in
situ (see Spec. 9, 1. 19) in the absence of the requirement for a "sterile"
matrix, the Examiner provides no evidence or reasoning establishing that the
resulting in situ composition after having been incubated for 16 to 24 hours
on an open wound would necessarily have been "sterile" as expressly
required by claim 1. Therefore, the word "sterile" is reasonably interpreted
as excluding in situ incubation because there is no evidence provided by
either the Examiner or Appellants suggesting that such an extended
incubation can be performed on a patient wound and result in a sterile
composition.
Therefore, even combining the teachings of Leek, Herlyn, Drohan,
Harichian, and Bilbo, there is no evidence that a wound healing
composition, after incubation for 16 to 24 hours in situ at 37°C as required
by claim 1, would have inherently been sterile or would obviously have been
sterile. Mehl, 192 F.3d at 1365. This is also not an In re Best, 562 F2.d
1252, 1255 (CCPA 1977) situation where the Examiner has shifted the
burden to Appellants because the obvious wound healing composition would
not have been expected to be substantially identical to the "sterile"
composition of Appellants and inherently remain sterile when placed on a
wound.
8 We also agree with the Examiner that the temperature of this incubation
would reasonably be "about" 37°C. See In re Harris, 409 F.3d 1339, 1343
(Fed. Cir. 2005) (The "[a]pplication's use of the term 'about' shows that the
applicants did not intend to limit the claimed ranges to their exact end-
points.")
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Application 10/589,227
We do not need to address the secondary consideration evidence
because the Examiner has not established a prima facie case of obviousness
over the claimed invention.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that Leek, Herlyn, Drohan, Harichian, and Bilbo render claim 1 obvious.
SUMMARY
In summary, we reverse the rejection of claims 1, 4, 8-10, 13-15, 17-
19, 23-28, 39--42, 44, 46, 48-51and63---65 under 35 U.S.C. § 103(a) as
obvious over Leek, Herlyn, Drohan, Harichian, and Bilbo.
REVERSED
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