Ex Parte LI et al

Board of Patent Appeals and Interferences

Jun 15, 2012

11305829 (B.P.A.I. Jun. 15, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte HUNG LI, DEMERAL DAVID LIU, WOEI-CHERNG SHYU,
and SHINN-ZONG LIN
____________

Appeal 2011-009766
Application 11/305,829
Technology Center 1600
____________

Before TONI R. SCHEINER, DONALD E. ADAMS, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 4, 8, 9, and 22-25
(App. Br. 2). We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a method of treating stroke. Claim 4 is
representative and is reproduced in the “CLAIMS APPENDIX” of
Appellants’ Brief.

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Claims 4, 8, 9, and 22 stand rejected under 35 U.S.C. § 112, second
paragraph.
Claims 4, 8, 9, and 22-25 stand rejected under 35 U.S.C. § 102(a) and
(e) as being anticipated by Bell1 as evidenced by Ramer2 and Vincent.3
Claims 4, 8, 9, and 22-25 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Bell, Ramer, Woodhall,4 Liu,5 Shahar,6
and Vincent.
We affirm the rejection under 35 U.S.C. § 112, second paragraph. We
reverse all other grounds of rejection.

Definiteness:
ISSUE
Is the phrase “collecting the cells” indefinite in the context of
Appellants’ claim 4?

1 Bell et al., US 2005/0214288 A1, published September 29, 2005.
2 Leanne M. Ramer, et al., Peripheral Olfactory Ensheathing Cells Reduce
Scar and Cavity Formation and Promote Regeneration after Spinal Cord
Injury, 473 The Journal of Comparative Neurology1-15 (2004).
3 Adele J. Vincent, et al., Morphological Plasticity of Olfactory Ensheathing
Cells Is Regulated by cAMP and Endothelin-1, 41 GLIA 393-403 (2003).
4 E. Woodhall, et al., Olfactory ensheathing cell phenotype following
implantation in the lesioned spinal cord, 60 CMLS, Cell. Mol. Life Sci
2241-2253 (2003).
5 Zhiping Liu et al., Pluripotent Fates and Tissue Regenerative Potential of
Adult Olfactory Bulb Neural Stem and Progenitor Cells, 21(10) Journal of
Neurotrauma 1479-1499 (2004).
6 Shahar et al., US 2007/0280989 A1, published December 6, 2007.
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FACTUAL FINDINGS (FF)
FF 1. Examiner finds that the phrase “collecting the cells” lacks antecedent
basis “in the claim because there are two cell populations that may be
obtained from the nasal polyp tissue, one population that migrates, and
another population that does not” (Ans. 3).
FF 2. Examiner finds that Appellants’ “Claim 24, for example, . . . clearly
recites that the collected cells are the migrated cells” (Ans. 10).
FF 3. Appellants “are receptive to amendments to claim 4 that would
resolve this issue” (App. Br. 5, n. 1).
FF 4. Examiner “suggests amending Claim 4 to recite ‘collecting the
migrated cells’” (Ans. 10).
ANALYSIS
Appellants’ claim 4 requires, inter alia, obtaining a tissue from a nasal
polyp of a human, culturing the nasal polyp tissue for 5-7 days to allow for
migration of the cells from the cultured tissue, and collecting the cells
(Claim 4). As Examiner explains, nasal polyp tissue comprises two cell
populations (FF 2). Thus, it is unclear from claim 4 precisely which cell
population is collected. This concern is confounded by Appellants’
reference, in claim 24, which depends from claim 4, to passaging the
migrated cells (Claim 24; FF 2). It is unclear why Appellants specifically
identify the cells in claim 24 as the migrated cells, while leaving claim 4
open to read on migrated cells, as well as cells that do not migrate.
While Appellants contend that “the cells” are collected and “the cells”
refers to the cells that migrated from the cultured tissue (App. Br. 4),
Appellants have indicated a willingness to amend claim 4 to clarify this
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issue and Examiner has suggested such an amendment to Appellants (FF 3-
4).
CONCLUSION OF LAW
The rejection of claim 4 under 35 U.S.C. § 112, second paragraph is
affirmed. Claims 8, 9, and 22 are not separately argued and fall together
with claim 4. 37 C.F.R. § 41.37(c)(1)(vii).

Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Bell as evidenced by Ramer and Vincent teaches
Appellants’ claimed invention?
FACTUAL FINDINGS (FF)
FF 5. Bell teaches the use of antibodies that specifically bind to the Nogo
receptor to treat “spinal cord injury, brain trauma, paralysis, degenerative
nervous system diseases, and stroke” (Bell, Abstract; Ans. 4).
FF 6. Bell teaches that the antibodies “may be administered alone or in
combination with other therapeutic or prophylactic regimens” for the
treatment of spinal cord injury (Bell 54: ¶ [0312]).
FF 7. Bell teaches that “experimental treatment/therapies for spinal cord
injuries fall into seven categories . . ., [which] address[ ] different aspects of
treating and/or ameliorating spinal cord injuries”, including
neuroconstructive and neurotrophic treatments/therapies (id. at 54: ¶ [0312]).
FF 8. In the context of neuroconstructive therapies, Bell teaches that “[t]he
antibodies . . . may be administered in combination with one or more
neuroconstructive agents such as . . . olfactory ensheathing glia” (id. at 55: ¶
[0319]; see generally Ans. 4; Cf. Bell 55: ¶ [0316] (In the context of
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neurotrophic therapies, Bell teaches that “the antibodies . . . may be
administered in combination with one or more neurotrophic agents such as
protein growth factors, purine nucleotides, cell adhesion molecules, and
hormones”)).
FF 9. Examiner relies on Ramer and Vincent to establish that olfactory
ensheathing cells express p75, GFAP, and S100 (Ans. 4).
ANALYSIS
Appellants contend that “Bell teaches a neuroconstructive therapy
using an anti-Nogo receptor antibody together with the various types of stem
cells listed in paragraph [319]” (App. Br. 5; FF 6-9). Appellants contend
that “Bell fails to disclose treating stroke by utilizing a composition that
includes olfactory ensheathing cells” (App. Br. 6). We agree.
Bell teaches the use of antibodies that specifically bind to the Nogo
receptor to treat “spinal cord injury . . . and stroke” (FF 5). Bell establishes
that the anti-Nogo antibodies may be used in combination with a variety of
other reagents for specific therapeutic applications (FF 8). For example,
Bells teaches the use of olfactory ensheathing glia in combination with anti-
Nogo antibodies for neuroconstructive therapy, but not for neurotrophic
therapies (id.). Examiner failed to establish an evidentiary basis to support a
finding that Bell teaches the use of olfactory ensheathing cells for the
treatment of stroke or that stroke would require the type of neuroconstructive
therapy that Bell teaches would benefit from a treatment comprising a
combination of anti-Nogo receptor antibody and olfactory ensheathing cells.
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner’s finding that Bell as evidenced by Ramer and Vincent teaches
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Appellants’ claimed invention. The rejection of claims 4, 8, 9, and 22-25
under 35 U.S.C. § 102(a) and (e) as being anticipated by Bell as evidenced
by Ramer and Vincent is reversed.

Obviousness:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 10. Examiner relies on Bell as discussed above (Ans. 5).
FF 11. Examiner finds that Bell fails to suggest the preparation of olfactory
ensheathing cells as set forth in Appellants’ claims (id.).
FF 12. Examiner relies on Ramer, Woodhall, Liu, Shahar, and Vincent to
suggest a process of preparing olfactory ensheathing cells (id. at 5-7).
ANALYSIS
Appellants contend that Bell fails to suggest “using cultured olfactory
ensheathing cells to treat stroke” and the “secondary references cited by the
Examiner fail to rectify these deficiencies” (App. Br. 7). In sum, Examiner
failed to establish that Ramer, Woodhall, Liu, Shahar, and Vincent make up
for the deficiency in Bell set forth above.
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support a
conclusion of obviousness. The rejection of claims 4, 8, 9, and 22-25 under
35 U.S.C. § 103(a) as unpatentable over the combination of Bell, Ramer,
Woodhall, Liu, Shahar, and Vincent is reversed.

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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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