Ex Parte Chen et al

Patent Trial and Appeal Board

Oct 13, 2017

13262274 (P.T.A.B. Oct. 13, 2017)

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.
13/262,274 02/14/2012 Xiao-Dong Chen UTSK.P0414US/11109579 4770
32425 7590 10/17/2017
NORTON ROSE FULBRIGHT US LLP
98 SAN JACINTO BOULEVARD
SUITE 1100
AUSTIN, TX 78701-4255
EXAMINER
PYLA, EVELYN Y
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
10/17/2017 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 XIAO-DONG CHEN and ZHONGDING LU
Appeal 2016-008032
Application 13/262,2741
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 1, 4—6, 9-11,
and 41 (Final Act.2 1). Examiner entered rejections under 35 U.S.C. § 112,
second paragraph and 35 U.S.C. § 103(a). We have jurisdiction under 35
U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as “The Board of Regents, The
University of Texas System” (App. Br. 1).
2 Examiner’s June 10, 2015 Final Office Action.
Appeal 2016-008032
Application 13/262,274
STATEMENT OF THE CASE
Appellants’ disclosure “relates to methods for isolating and growing
mesenchymal stem cells from umbilical cord blood (UCB)” (Spec. 1:15—
16). Claims 1 and 41 are representative and reproduced below:
1. A method of isolating mesenchymal stem cells (MSCs)
comprising:
(a) collecting a sample containing the mononuclear cell
fraction of umbilical cord blood (UCB);
(b) forming an extracellular matrix (ECM)-precoated
culture dish by culturing human bone marrow cells on
the surface of a culture dish;
(c) seeding the sample on the ECM-precoated culture dish;
and
(d) isolating the MSCs from the sample;
wherein the ECM comprises collagen type I, collagen type III,
fibronectin, biglycan, decorin, perlecan, and laminin.
(App. Br. 11.)
41. The method of claim 1, wherein the frequency of the
isolated MSCs obtained from the sample is 22,800 to 37,000
out of 1x10s mononuclear cells.
{id. at 12 (emphasis added).)
The claims stand rejected as follows:
Claim 41 stands rejected under 35 U.S.C. § 112, second paragraph.
Claims 1, 4, 9, and 41 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Chen.3
Claims 5 and 6 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Chen and Lin.4
3 Chen et al., US 2008/0175816 Al, published July 24, 2008.
4Lin et al., US 2007/0128722 Al, published June 7, 2007.
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Application 13/262,274
Claims 10 and 11 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Chen and Lee.5 *
Definiteness'.
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that the recitation of the range “22,800 to 37,000,” as it appears in
Appellants’ claim 41, is indefinite for failing to identity the units associated
with the range?
ANALYSIS
Appellants’ claim 41 depends from Appellants’ claim 1, both of
which are reproduced above. The method of Appellants’ claim 1 is for
isolating mesenchymal stem cells and comprises a number of steps, which
starts with “collecting a sample containing the mononuclear cell fraction of
umbilical cord blood (UCB)” and concludes with the last step of “isolating
[mesenchymal stem cells] from a sample” (see App. Br. 11 (emphasis
added)). Appellants’ claim 41, depends from and further limits Appellants’
claim 1 to require that “the frequency of the isolated [mesenchymal stem
cells] obtained from the sample is 22,800 to 37,000 out of 1x10s
mononuclear cells” (App. Br. 12 (emphasis added)).
Examiner finds that it is unclear whether Appellants’ claim 41
“requires 22,800 to 37,000 cells out of lxl 08 mononuclear cells or if the
claim requires 22,800 to 37,000 CFU (colony forming units) out of 1x10s
mononuclear cells” (Ans. 2 (emphasis added)). On this record, Examiner
5 Oscar K. Lee et al., Isolation of multipotent mesenchymal stem cells from
umbilical cord blood, 103 BLOOD 1669—1675 (2004).
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Application 13/262,274
interpreted the range as a measure of cell count; specifically, 22,800 to
37,000 cells (see Ans. 14; see also Final Act. 9—10). Given the repeated
reference to the term “cells’ ’ in both of Appellants’ claims 1 and 41, we find
no error in Examiner’s claim construction.
Appellants contend, however, that “[w]hen read in light of
[Appellants’] [Specification, it is clear that th[e] range[, in Appellants’
claim 41,] refers to CFUs” (App. Br. 2). We are not persuaded.
Appellants’ Specification discloses that “[according to the
measurement of colony formation units (CFUs) the frequency of UCB-
MSCs[, mesenchymal stem cells,] is 22,800 — 37,000 out of 1 x 108 MNCs[,
mononuclear cells], at least 1,000 fold . . . greater than previously reported
by others . . .” (Spec. 8: 5—7 (emphasis added); see App. Br. 2). Thus,
although Appellants’ Specification discloses a “measurement of colony
formation units (CFUs),” Appellants’ Specification discloses that according
to this measurement a frequency of UCB-mesenchymal stem cells out of
mononuclear cells can be determined and is 22,800 — 37,000 out of 1 x 108
(Spec. 8: 5—7; see Reply Br. 5 (Appellants’ “claim language itself provides
the units of measure: the 22,800 to 37,000 values represent ‘isolated
[mesenchymal stem cells].’ Thus, the only reasonable interpretation of the
claim is that it requires 22,800 to 37,000 isolated [meshenchymal stem cells]
out of lxl08 mononuclear cells” and “a frequency value[ is] the number of
isolated [meshenchyman stem cells] out of a given number of seeded
[mononuclear cells]”). Thus, while the term “CFUs” is used in Appellants’
Specification, the claimed range is disclosed in terms of cells (see id.).
It is entirely proper to use the specification to interpret what the
patentee meant by a word or phrase in the claim. See, e.g.,
Loctite Corp. v. Ultraseal Ltd., 781 F.2d 861, 867, 228 USPQ
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Application 13/262,274
90, 93 (Fed. Cir. 1985). But this is not to be confused with
adding an extraneous limitation appearing in the specification,
which is improper. By “extraneous,” we mean a limitation read
into a claim from the specification wholly apart from any need
to interpret what the patentee meant by particular words or
phrases in the claim. “Where a specification does not require a
limitation, that limitation should not be read from the
specification into the claims.” Specialty Composites v. Cabot
Corp., 845 F.2d 981, 987 (Fed. Cir. 1988) (emphasis in
original), citing Lemelson v. United States, 752 F.2d 1538,
1551-52, 224 USPQ 526, 534 (Fed. Cir. 1985).
E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430,
1433 (Fed. Cir. 1988). For the reasons set forth above, we find that neither
Appellants’ Specification nor claims require the term CFU to be read from
Appellants’ Specification into their claims.
CONCLUSION OF LAW
The preponderance of evidence supports Examiner’s conclusion that
the recitation of the range “22,800 to 37,000,” as it appears in Appellants’
claim 41, is indefinite for failing to identity the units associated with the
range.
The rejection of claim 41 under 35U.S.C. § 112, second paragraph is
affirmed.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
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Application 13/262,274
FACTUAL FINDINGS (FF)
We adopt Examiner’s findings concerning the scope and content of
the prior art (Ans. 2—9), and provide the following findings for reference
purposes.
FF 1. Chen “disclose[s] mesenchymal stem cells (MSCs) cultured on an
ECM made by marrow stromal cells thereby reconstituting the MSC niche.
This ECM specifically promotes self-renewal of MSCs and retention of their
multipotentiality” (Chen § 12; see id. § 94; Ans. 3 4).
FF 2. Chen discloses that “[sjtromal cell-derived ECM may comprise
collagen types I, III, and V, syndecan-1, perlecan, fibronectin, laminin,
biglycan and decorin, and resembles the marrow ECM” (Chen § 14; see
Ans. 3^4; cf. Appellants’ claim 1 (“the ECM comprises collagen type I,
collagen type III, fibronectin, biglycan, decorin, perlecan, and laminin”)).
FF 3. Chen discloses that “[mjammalian mesenchymal stem cells may be
obtained from various sources, including, but not limited to, bone marrow
[and] . . . umbilical cord” and methods of “[isolating and establishing
cultures of mesenchymal stem cells are generally known to those of skill in
the relevant art” (Chen § 52; Ans. 4).
FF 4. Chen exemplifies a method wherein:
Primary human bone marrow mononuclear cells (hBMCs,
purchased from AllCells, LLC.) were placed onto either the
ECM made by human marrow stromal cells (hMSC-ECM) or
tissue culture plastic at various cell seeding densities (2, 1, and
0.5xl06 cells per well). After 4 hours of incubation, the non­
adherent cells were removed by rinsing with PBS once. Then
the cells were cultured in [osteogenic induction medium (a-
MEM)] containing 15% FCS for 2 weeks.
(Chen § 100; see also id. at § 46; see Ans. 3^4.)
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Application 13/262,274
FF 5. Examiner finds that Chen’s disclosure of:
1) obtaining commercially available human bone marrow
mononuclear cells (MNCs), [] reads on “collecting a sample
containing the mononuclear cell fraction”;
2) seeding the mononuclear cells onto either ECM made by
human bone marrow cells, which reads on “forming an
extracellular matrix (ECM)-precoated culture dish by culturing
human bone marrow cells on the surface of a culture dish” and
“seeding the sample on the ECM-precoated culture dish”;
3) removing non-adherent cells after four hours of culture, thus
isolating the adherent MSCs, and further culturing for 2 weeks,
which reads on “isolating the MSCs from the sample”.
(Ans. 3—4.)
FF 6. Chen discloses that “[cjulture on stromal cell-derived ECM
facilitates retention of MSC properties. The ECM affects MSC adherence
and proliferation. MSCs were detected and quantified by their ability to
form a colony of fibroblastic cells. These colony-forming cells, called
colony forming unit-fibroblasts (CFU-F), comprise MSCs” (Chen § 84
(endnote omitted)).
FF 7. Chen discloses
When cultured on the stromal cell-derived ECM, there
was approximately a two to three fold increase in the number of
CFU-F as compared to tissue culture plastic, demonstrating that
the ECM promoted MSC attachment . . . indicating] that a
collagen-containing ECM uniquely promotes the proliferative
capacity of MSCs and/or their transit amplifying progeny.
(Chen § 85; see id. § 94 (“[t]he number of CFU-F colonies was increased
approximately 4 8-fold when the cells were pre-cultured on stromal cell-
derived ECM as compared approximately 9-fold or approximately 27-fold in
cultures maintained on plastic or Type I collagen gel, respectively []”); see
also id. § 84; see Ans. 3).
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Application 13/262,274
FF 8. Chen’s Figures 3B—3D are reproduced below:
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Chen discloses that:
Figs. 38, 3Cmd3D
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FIG. 3B illustrates CFU-F number as determined at
indicated seeding densities.
FIG. 3C illustrates the appearance of CFU-F derived
from cells cultured into a cell-free stromal cell-derived ECM,
plastic, or 2D fibronectin or Type I collagen matrices.
FIG. 3D illustrates the number of cells per CFU-F colony
as determined at indicated seeding densities. *P<0.05, n=3 vs.
plastic or the 2D matrices containing fibronectin or Type I
collagen at the same density. tP<0.05, n=3 compared to plastic
or the 2D matrices containing fibronectin.
(Chen || 27—29; see Ans. 3 (Chen’s “Fig. 3D[ illustrates] the number of
cells per colony forming unit (CFU) for cells seeded at a density of 1 x 106,
on ECM substrate derived from stromal cells, was approximately 70 x 103
per 106 cells, i.e. 7 x 106 per 108 seeding after five days of culture . . .”).)
FF 9. Examiner finds that “[t]he only difference between Chen[’s]
Example 8 and [Appellants’] claims is that Chen [] does not exemplify a
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Application 13/262,274
single embodiment with sufficient specificity to be anticipatory for umbilical
cord tissues, specifically umbilical cord blood tissue” (Ans. 4).
FF 10. Examiner finds that Chen fails to exemplify the collecting a sample
containing the mononuclear cell fraction of UCB “after birth or subjecting
the sample to centrifugation in order to isolate the mononuclear fraction”
and relies on Lin to make up for this deficiency in Chen (Ans. 7—8).
FF 11. Examiner finds that although Chen “discloses the differentiation
potential of the isolated MSCs to form bone tissues . . Chen fails to
“specifically teach [] differentiated tissue comprising three embryonic germ
layer-derived tissues upon implantation” and relies on Lee to make up for
this deficiency in Chen (Ans. 8—9).
FF 12. Campagnoli6 discloses:
The frequency of adherent colonies in first-trimester blood was
8.2 ± 10 colonies/100 pL fetal blood). Adherent fibroblastlike
colonies could not be isolated from second- and third-trimester
fetal blood samples cultured under identical conditions.
However, when mononuclear cells from second- and third-
trimester samples were enriched by single-density
centrifugation and plated at a 25-fold higher concentration (2.5
x 106 cells/mL) than were used for first-trimester blood, small
numbers of colonies of adherent cells did develop. Colonies
were smaller than those derived from first-trimester blood
(fewer than 100 cells/colony) and were present at lower
frequencies: 1.3/106 cells plated (second trimester, n = 1) and
6 Cesare Campagnoli et al., Identification of mesenchymal stem/progenitor
cells in human first-trimester fetal blood, liver, and bone marrow, 98
BLOOD 2396-2402 (2001).
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Application 13/262,274
0.35/106 cells (term cord blood, n = 4) versus first-trimester
fetal blood (8.2/106 cells).
(Campagnoli 2398, right column; see also id. at 2396, left column (“MSCs
in their undifferentiated state are spindle shaped and resemble fibroblasts”);
see also Chen Decl.71 5.)
FF 13. Campagnoli discloses that
[f]irst-trimester blood samples . . . were collected by
cardiocentesis. . . . Second-trimester blood samples . . . were
collected . . . from the cord or during clinically indicated fetal
blood sampling from the umbilical vein. . . . Third-trimester
blood samples . . . were obtained from the umbilical cord at
delivery from uncomplicated pregnancies.
(Campagnoli 2396, right column —2397, left column; see also Chen Decl.
15)
FF 14. Chen declares that by “[f]ollowing the methods disclosed in
[Appellants’ Specification] . . . 22,800 — 37,000 CFU-Fs per 1 x 108 total
cells plated, which equates to 228 — 370 MSCs per 1 x 106 total cells plated.
Specification at page 8, lines 5-7” (Chen Decl. 1 6).
FF 15. Chen declares that by following the methods disclosed in
Appellants’ Specification MSCs were isolated at “a much higher rate than
would have been expected by persons of ordinary skill in the art based on
what was known at the time”, citing Campagnoli (see id.).
1 Declaration of, co-inventor, Xiao-Don Chen, Ph.D., signed March 10,
2015.
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Application 13/262,274
ANALYSIS
The rejection of claims 1, 4, and 41 over Chen:
Claims 1 and 4\
Based on Chen, Examiner concludes that, at the time Appellants’
invention was made, it would have been prima facie obvious to “have
selected umbilical cord mesenchymal stem cells” as the source of a
mononuclear cell fraction for use in a method of isolating MSCs “to arrive at
a method ‘yielding no more than one would expect from such an
arrangement’” (Ans. 5; see also id. at 4 (“one having ordinary skill in the art
would have found [the use a mononuclear cell fraction of umbilical cord
blood] prima facie obvious based on the overall disclosure of mesenchymal
stem cells obtained from umbilical cord as a suitable source for the
mesenchymal stem cells”); FF 3; see also FF 1,2, and 4—9).
Appellants appear to contend that because Chen discloses and
exemplifies the use of marrow-derived mononuclear cells “one would not
[have been] motivated to substitute the umbilical cord cells (UCBs) for the
bone marrow-derived MSCs of Chen (see, for example, Chen at | [0026]
and [0077])” (App. Br. 3 (alteration original); see id. at 8 (“Chen does not
suggest isolating MSCs from UCB by seeding a UCB sample on a bone
marrow cell-derived ECM”); see also id. at 8—9). We are not persuaded. As
Examiner explains, the “use of umbilical cord blood” as the source of
starting material for the isolation of mesenchymal stem cells “is within the
scope of the teachings of Chen []” (Ans. 10; see FF 3). Therefore, we are
not persuaded by Appellants’ contention that in order to make obvious the
subject matter of Appellants’ “claim 1 . . . Chen [] must do more than
suggest that MSCs can be derived from UCB; it must suggest isolating
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MSCs by plating an MNC-containing fraction from UCB on an ECM
generated by bone marrow cells” (Reply Br. 1). Notwithstanding
Appellants’ contention to the contrary, Chen suggests isolating MSCs by
plating an MNC-containing fraction from UCB on an ECM generated by
bone marrow cells (see FF 1—9; cf Reply Br. 1—2).
Chen discloses that MSCs may be obtained from both bone marrow
and UCB (FF 3). Appellants fail to establish that MSCs isolated from bone
marrow exhibit different properties than MSCs isolated from UCB.
Therefore, the evidence on this record supports a conclusion that, at the time
of Appellants’ claimed invention, a person of ordinary skill in this art would
have reasonably concluded that whether isolated from bone marrow or UCB,
MSCs will exhibit the same ability to adhere to plastic or an ECM-precoated
culture dish (see FF 1,2, and 4—8).
Notwithstanding Appellants’ contention to the contrary, Examiner’s
obviousness rationale is to isolate MSCs from UCB by plating UCB derived
cells onto plates comprising ECM made by marrow stromal cells, which
Chen demonstrates is a better support to facilitate MSC attachment than
plastic (see Reply Br. 2 (“Examiner’s proposed modification to Chen [] is to
substitute USB for bone marrow, not to substitute ECM for plastic”); cf. FF
1-9). KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of
ordinary skill is also a person of ordinary creativity, not an automaton”).
Chen discloses that MSCs “[c]ulture[d] on stromal cell-derived ECM
facilitates retention of MSC properties” and that “[t]he ECM affects MSC
adherence and proliferation” (FF 6; see also FF 7—8). Appellants’ disclosure
confirms Chen’s results (see Spec. 8: 1 (human UCB contains a large
number of MSCs that adhere to ECM, but not to plastic”)).
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Application 13/262,274
Appellants’ claims 1 and 4 are not limited to the use of second or third
trimester UCB and do not relate to the isolation of MSCs from UCB-derived
MSCs on plastic (see App. Br. 11). Further, Appellants do not identify, and
we do not find, a disclosure in Appellants’ Specification that specifically
describes the term UCB as isolated during any specific gestational time
period, e.g., first, second, or third trimester. In sum, the evidence on this
record fails to support Appellants’ contention that Campagnoli is “[t]he
closest prior art” to Appellants’ claimed invention (see App. Br. 6; see also
FF 12; cf. FF 1-9).
Therefore, we are not persuaded by Appellants’ contentions regarding
Campagnoli’s disclosure relating to the isolation of MSCs by culturing
second or third trimester UCB-derived MSCs on plastic or the discussion of
Campagnoli in the Chen Declaration, which are not commensurate in scope
with Appellants’ claimed invention (App. Br. 3—8; see Reply Br. 1—2; FF
12—15). Further, given the lack of evidence on this record as to the precise
source of Appellants’ UCBs, and the prior art recognized differences in
adherence between plastic and ECM-precoated culture dishes, the
comparisons articulated by Appellants and Declarant relating to Appellants’
results and the results of Campagnoli lack evidentiary support (see App. Br.
3—8; Reply Br. 3—5; see also FF 12—15).
In contrast, there is no evidence on this record to support a conclusion
that a person of ordainry skill in this art would have reasonably expected that
MSCs would exhibit different adherent properties if isolated from bone
marrow as opposed to UCB and Chen discloses that ECM-precoated culture
dishes result in better MSC adherence than MSC cultured on plastic, a
person of ordinary skill in this art would recognize that Chen is the closest
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prior art to Appellants’ claimed invention on this record and, for the reasons
set forth above and by Examiner, makes obvious Appellants’ claimed
invention (cf Reply Br. 3 (“Chen [] is not the closest prior art because it
does not disclose seeding mononuclear cells from UCB at all”)).
Claim 41\
Examiner concludes that “the cell density disclosed by Chen []
overlaps [Appellants’] claimed range” and that “where the claimed ranges
‘overlap or lie inside ranges disclosed by the prior art’ aprima facie case of
obviousness exists (Ans. 7). See In re Geisler, 116 F.3d 1465, 1468, 43
USPQ2d 1362, 1363 (Fed. Cir. 1997); Iron Grip Barbell Co. v. USA Sports,
Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). In this regard, Examiner reasons
that because Appellants’ claim 41 fails to define the units of the claimed
range, and because the claims fail to identify the time in culture, absent
evidence to the contrary, Chen’s disclosure of “7 x 106 cells per 108 seeding
after five days of culture” reads on the range set forth in Appellants’ claim
41 (Ans. 7; see FF 8; see also Reply Br. 5 (Appellants’ “claim language
itself provides the units of measure: the 22,800 to 37,000 values represent
‘isolated [mesenchymal stem cells]”’); see also FF 14 (equating CFU-F to
cell count)). Therefore, we are not persuaded by Appellants’ contentions
relating to colony forming units, as opposed to cells (see App. Br. 9-10).
For the reasons set forth above with respect to claim 1, we are not
persuaded by Appellants’ contentions relating to Campagnoli (Reply Br. 5—
6). Appellants fail to provide an evidentiary basis on this record to support a
conclusion that the number of cells, as relied upon by Examiner, is not the
number of mesenchymal stem cells (MSCs) (see Reply Br. 5—6).
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The rejection over Chen in combination with Lin orLee\
Based on the combination of Chen in combination with Lin, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious “to collect the umbilical cord blood after [] birth
and utilize a well-known technique, i.e. centrifugation, for the isolation of
the mononuclear cell fraction, as disclosed by Lin” (Ans. 8).
Based on the combination of Chen in combination with Lee,
Examiner concludes that, at the time Appellants’ invention was made, it
would have been prima facie obvious to “have expected the MSCs, derived
from umbilical cord blood, to differentiate into cell types of all 3 germ layers
as required of [Appellants’] claims 10 and 11” (Ans. 9).
Having found no deficiency in Chen, we are not persuaded by
Appellants’ contention that “[njeither of the additional cited references—Lin
or Lee—. . . remedies] the failure of Chen to teach or suggest the claim 1
limitation of isolating MSCs from UCB by plating a UCB sample on
marrow cell-derived ECM” (App. Br. 10).
CONCLUSION OL LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claims 1 and 41 under 35 U.S.C. § 103(a) as
unpatentable over Chen is affirmed. Claims 4 and 9 are not separately
argued and fall with claim 1.
The rejection of claim 5 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Chen and Lin is affirmed. Claim 6 is not separately
argued and falls with claim 5.
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The rejection of claim 10 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Chen and Lee is affirmed. Claim 11 is not
separately argued and falls with claim 10.
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
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