Ex Parte POLLNER et al

Patent Trial and Appeal Board

Sep 17, 2018

13164605 (P.T.A.B. Sep. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/164,605 06/20/2011
13837 7590 09/19/2018
Alston & Bird LLP/ Gen-Probe Incorporated
Bank of America Plaza
101 South Tryon Street, Suite 4000
Charlotte, NC 28280-4000
FIRST NAMED INVENTOR
Reinhold B. POLLNER
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.
GPl 79-03.DVl 2096
EXAMINER
POHNERT, STEVEN C
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
09/19/2018 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):
usptomail@alston.com
patentdept@hologic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte REINHOLD B. POLLNER, MICHAEL M. BECKER, and
MEHRDAD R. MAJLESSI
Appeal2017-005716
Application 13/164, 605
Technology Center 1600
Before MICHAEL J. FITZPATRICK, ULRIKE W. JENKS, and
DAVID COTTA, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants 1 appeal from the
Examiner's decision to reject claims as indefinite and obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Claims 16, 18, 19, 21-26, 28, 29, 31-34, 37, and 38 are on appeal,
and can be found in the Claims Appendix of the Appeal Brief. Claim 16 is
representative of the claims on appeal, and reads as follows:
1 Appellants identify the real party in interest as Gen-Probe Incorporated.
Br. 2.
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Application 13/164,605
16. A hybridization mixture for capturing a target nucleic
acid, the mixture comprising imidazole at a concentration from
0.05 M to 4.2 M, at least one target nucleic acid, at least one
capture probe comprising a target-specific region
complementary to a target sequence in the target nucleic acid
and an immobilized probe-binding region, and an immobilized
probe complementary to the immobilized probe-binding region
of the capture probe, wherein the mixture is at a temperature of
about 85°C to 95°C.
Appeal Br. 13 (Claims Appendix)(emphasis added). The only other
independent claim, claim 28, recites the same limitations but uses a different
imidazole concentration, specifically, "imidazole at a concentration of about
1.7 M to 2.7 M." Id. at 14.
Appellants request review of the following grounds of rejection made
by Examiner:
I. Claims 16, 18, 19, 21-26, 28, 29, 31-34, 37, and 38 under
35 U.S.C. § 112, second paragraph.
II. Claims 16, 18, 19, 21-26, 28, 29, 31-34, 37, and 38 under
35 U.S.C. § 103(a) as unpatentable over the combination of
Weisburg2 and Eli. 3
I. Indefiniteness
The Patent Office applies the broadest reasonable claim interpretation
standard in proceedings. Cuozzo Speed Tech., LLC v. Lee, 136 S. Ct. 2131,
2145 (2016). Examiner interprets the claims to be drawn to a product. See
2 Weisburg et al., US 6,280,952 Bl. Issued Aug. 28, 2001 ("Weisburg").
3 Eli et al., Characterization of Imidazole as a DNA Denaturant by Using
TGGE of PCR Products from a Random Pool of DNA, 125 J. Biochem. 790-
794 (1999)("Eli").
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Ans. 25; see Final Act. 11, 13. Appellants contend "that physical properties
of a composition, such as temperature," must be considered as well in
comparing the properties of the composition to the prior art. Appeal Br. 12.
Claims 16 recites a preamble: "[a] hybridization mixture for capturing
a target nucleic acid." "Where ... a patentee defines a structurally complete
invention in the claim body and uses the preamble only to state a purpose or
intended use for the invention, the preamble is not a claim limitation." Rowe
v. Dror, 112 F.3d 473,478 (Fed. Cir. 1997); IMS Tech., Inc. v. Haas
Automation, Inc., 206 F.3d 1422, 1434 (Fed. Cir. 2000) ("If the preamble
adds no limitations to those in the body of the claim, the preamble is not
itself a claim limitation and is irrelevant to proper construction of the
claim.").
Upon consideration of the evidence and Appellants' contentions, we
agree with Examiner that claim 16 is directed to a product. The body of the
claim defines a structurally complete composition, a mixture, which
includes: imidazole, a target nucleic acid, a capture probe, and an
immobilized probe. Because the body of the claim defines a structurally
complete invention, the claim preamble does not add any limitations to the
body of the claim and therefore is not considered part of the claimed
composition.
The claim additionally recites "wherein the mixture is at a temperature
of about 85°C to 95°C." Examiner finds it unclear what the "wherein"
clause recited in claim 16 (and claim 28) intends to achieve. Final Act. 4.
Specifically, it is unclear if the intent is that the temperature of the
component mixture needs to be between 85-95°C to meet the limitation or if
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this limitation indicates that the capture probe is designed to work at a
temperature between 85-95°C. Final Act. 4; Ans. 3--4.
Appellants contend that one of ordinary skill would understand that
the composition is being claimed at the stated temperature, "and would have
no difficulty in ascertaining whether a composition was within such a range
by use of a thermometer or similar instrument." Appeal Br. 6.
With respect to the temperature limitation, we agree with Appellants
that there is no difficulty in measuring the temperature of a component
mixture by using, for example, a thermometer. We note that claim 16,
however, does not recite any duration for how long the mixture needs to
remain at the recited temperature. Claim 16 also does not recite any
limitations on the interactions of the various components at the recited
temperature. All that is required to meet the temperature limitation of claim
16, is that the component mixture at some point in time, even if just
temporarily, touches this range.
Examiner notes the Specification does not provide a limiting
definition of "about." Ans. 5. Examiner interprets the limitation "about" as
encompassing temperatures plus or minus 20%. Ans. 5; Final Act. 5.
Appellants contend that the term "about" should be construed in such
a way that it encompasses "insubstantial variation from either end of the
range not having any material effect on the properties of the composition."
Appeal Br. 6; see Reply Br. 2. 4 Appellants contend that this limitation
4 Appellants state that the Examiner refused to enter an amendment deleting
the term "about" and note that they remain willing "to make the
amendements previously offered or any other reasonable amendments that
may be proposed by the Examiner to remove issues for appeal. Reply Br. 2.
We limit our consideration to the claim before us and do not consider
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should not be construed "as encompassing variations exceeding 50% of the
recited range so as to overlap with the range of Eli." Appeal Br. 11.
The Specification provides that the temperature range of the preferred
embodiments includes relatively mild conditions "which may be used at
room temperature or heated for a short time, e.g., about 60-95 °C for 15
minutes or less." Spec. 9. "Assays performed with imidazole in the target
capture reaction incubated at lower temperatures (25°C to 42°C) typically
resulted in less total detectable signal compared to target capture assays
performed using the same capture probe in a reaction mixture without
imidazole incubated at higher temperature ( 60°C)." Spec. 11. The
Specification demonstrates that the temperature can vary greatly and still
produce the desired effect of capturing nucleic acid even if at lower
efficiency. The Specification suggests that variations as great as 20%
temperature have no material effect on the composition's components.
However, we need not determine the precise numerical variance
encompassed within the claim term "about." For purposes of our discussion,
it is sufficient that "about 85°C to 95°C" encompasses the prior art range
disclosed in Eli- between 75°C and 80°C.
amendments not entered because a refusal to enter an amendment is a
petitionable matter under 3 7 C.F .R. § 1.181 and not within the jurisdiction of
the Board. 37 C.F.R. § 1.127 (2011); In re Berger, 279 F.3d 975,984 (Fed.
Cir. 2002) (citing In re Hengehold, 440 F.2d 1395, 1403-1404 (CCPA
1971).)
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Examiner's position is that "[t]he term 'target-specific region
complementary' and an [']immobilized probe complementary' in claim 16
[are] relative term[ s] which render[] the claim indefinite. The term
'complementary' is not defined by the claim[s], and the [S]pecification does
not provide a standard for ascertaining the requisite [base pair match
between nucleic acid sequences. Therefore,] one of ordinary skill in the art
would not be reasonably apprised of the scope of the invention." Final
Act. 3 ( citing Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ( expanded
panel); see Ans. 2. In other words, it is not clear what level of
"complementary" is required to meet this claim limitation. Final Act. 4.
Appellants contend that the Specification and indeed the claims recite
the purpose of the composition which is to capture the target nucleic acid.
Appeal Br. 5. Appellants note that the length of sequence that needs to be
complementarity depends on the GC content of nucleic acids and
hybridization conditions provided. Id.
Findings of Fact
FF 1. The Specification provides:
"Hybridization conditions" refer to the cumulative physical and
chemical conditions under which nucleic acid sequences that
are completely or partially complementary form a hybridization
duplex or complex, usually by standard base pairing. Such
conditions are well known to those skilled in the art, are
predictable based on sequence composition of the nucleic acids
involved in hybridization complex formation, or may be
determined empirically by using routine testing ( e.g., Sambrook
et al., Molecular Cloning, A Laboratory Manual, 2nd ed. (Cold
Spring Harbor Laboratory Press, Cold Spring Harbor, NY,
1989)[)].
Spec. 7: 18-23.
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Analysis
Temperature is a physical conditions that affects when one nucleic
acid sequence will hybridize to another nucleic acid sequence containing a
complementary sequence. See FF 1.
Claim 16 recites three different nucleic acid structures. Two of the
nucleic acid structures, the target nucleic acid and the immobilization probe,
bind to the third structure, the capture probe. Claim 16 also recites a
temperature, requiring that "the mixture is at a temperature of about 85QC to
95QC." The problem is that claim 16 does not make clear whether the recited
temperature applies to binding: 1) the target nucleic acid with the
complementary region of the capture probe, 2) the immobilization probe
with the complementary region of the capture probe, or 3) both the target
nucleic acid and the immobilization probe with the complementary region of
the capture probe. 5 Given this ambiguity, it is not possible to determine
whether the recited nucleic acid structures are complementary to each other
as required by the claims.
Therefore, we agree with Examiner that the "complementarity"
limitation recited in the claim is not clear. Specifically, it is not clear if the
5 The Specification recognizes that the hybridization of the target nucleic
acid sequence to the capture probe may occur at a different temperature than
the hybridization of the capture probe to the immobilization probe. See,
Spec. 9 ("In preferred embodiments, hybridization conditions include a
soluble denaturant chemical in the mixture that contains the capture probe
and target nucleic acid and incubation of the mixture at 60°C to 95°C,
preferably 75°C to 95°C, for about 15 min or less to permit formation of a
hybridization duplex of the capture probe and target nucleic acid, followed
by incubation at a lower temperature (e.g., about 25°C to 42°C) to permit
formation of a hybridization complex made up of the target nucleic acid,
capture oligomer, and immobilized probe.").
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probes need to bind at a particular temperature, and if so which probes need
to bind at that temperature. See Final Act. 3. Therefore, we agree with
Examiner's conclusion that the term "complementarity" as recited in the
claim 16 is indefinite.
We affirm the rejection of claim 16 is being indefinite. Claims 18, 19,
21-26, 28, 29, 31-34, 37, and 38 were not separately argued and fall with
claim 16.
II. Obviousness over Weisburg and Eli
The issue is: (1) does the preponderance of evidence of record support
Examiner's conclusion that the claims are obvious in light of the cited
references, and (2) if so do Appellants present sufficient rebuttal evidence of
unexpected results to overcome the prima facie case of obviousness?
Findings of Fact
FF2. Weisburg teaches a polynucleotide capturing method:
The method includes the steps of incubating a mixture
comprising a target polynucleotide, a capture probe, and
an immobilized probe in a first hybridization condition
that favors formation of a capture probe:target
hybridization complex that includes the capture probe
and the target polynucleotide, wherein the first
hybridization condition disfavors formation of an
immobilized probe:capture probe hybridization complex
that includes the immobilized probe and the capture
probe; and then incubating the mixture in a second
hybridization condition that favors formation of the
immobilized probe:capture probe hybridization complex,
thereby capturing the target polynucleotide in an
immobilized probe:capture probe:target hybridization
complex that includes the immobilized probe, the capture
probe and the target polynucleotide.
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Weisburg 2:9--23.
FF3. W eisburg teaches that "the first incubating step uses a temperature
below a Tm of the capture probe:target hybridization complex and
above a Tm of the immobilization probe:capture probe hybridization
complex, and the second incubating step uses a temperature below a
Tm of the immobilization probe: capture probe hybridization
complex." Id. 2:24--29. Weisburg's preferred embodiments teach
temperatures of about 60°C to 40°C or lower. See id. 2:41-34.
FF4. Weisburg teaches "Tm can be predicted using standard calculations
and measured using routine testing techniques well known in the art."
Id. 16:5-7 (citing Sambrook et al., Molecular Cloning, A Laboratory
Manual, 2nd ed. (Cold Spring Harbor Laboratory Press, Cold Spring
Harbor, N.Y. 1989)).
FF5. Weisburg teaches that using temperature changes in order to change
hybridization conditions is compatible with automation. See id.
16:24--26. "However, any known method of lowering the stringency
of a hybridization condition, such as by increasing the ionic strength
of the solution or diluting the solution with denaturants, may be used
to achieve the second hybridization condition." Id. at 16:33-38.
FF6. Eli teaches "that imidazole can destabilize the double-stranded form
of DNA just like urea and formamide." Eli at 790. "1 M, imidazole
lowered the melting temperature (Tm) of DNA by 13±2°C.". Id.
Abstract, 794. Eli uses temperature gradient gel electrophoresis with
a temperature gradient from about 30 to 80°C. "[W]e performed
TGGE in which both the gel and running buffer contained 0.1, 0.3,
1.0, or 3.0 M imidazole." Id. 793.
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Principle of Law
"[T]he patentability of ... composition claims depends on the claimed
structure, not on the use or purpose of that structure." Catalina Mktg. Int'!,
Inc. v. Coo/savings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002).
Analysis
To summarize, Examiner finds that Weisburg teaches an assay that
utilizes two hybridization conditions in order to capture and isolate a target
nucleic acid. The first hybridization condition allows for the capture probe
to bind to the target polynucleotide and the second hybridization condition
allows for hybridization between the capture probe and an immobilized
probe. Final Act. 6; Ans. 5; FF2-FF3. Examiner finds that Weisburg also
teaches the use of denaturants. Final Act. 6; FF5. Examiner finds that
Weis burg teaches that the melting temperature of hybridization complexes is
affected by the length and degree of complementarity between two nucleic
acid sequences and that the stability of a complex can be readily calculated.
See Final act. 7-8, see id. at 8 ("For example, G:C pairing is stronger than
A:T pairing, due to more hydrogen bonds in G:C pairs"); see Ans. 7; FF4.
Examiner finds that "W eisburg teaches the method of the invention
alters Tm and hybridization conditions. W eisburg teaches these alterations
include the use of denaturants." Ans. 5. Examiner acknowledges that
"W eisburg does not specifically teach the use of imidazole" and relies on Eli
for this teaching. Final Act. 9; Ans. 8. Eli teaches that imidazole is a
stronger denaturant of DNA then urea. Ans. 9; FF6. Examiner concludes
that it would have been obvious to substitute one denaturant for another. See
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Final Act. 10 ("Weis burg further suggests the use of denaturants, while Eli
demonstrates that imidazole is known as a strong denaturant"); see Ans. 10.
Examiner interprets the claim to be a product claim and finds that the
recitation of "wherein the mixture is at a temperature of about 85°C to
95°C" is a description of the intended use, while a product is analyzed based
on the structure. See Final Act. 11. We agree that claim 16 is directed to a
product (see above I.). Based on this interpretation Examiner concludes that
the combined references provide the requisite components and suggests the
addition of imidazole as a suitable denaturant to arrive at the presently
claimed invention. Final Act. 10-11.
Appellants contend that Examiner's prima facie case is in error
because limiting the claim to only consider "structural properties and that
anything relating to its use is irrelevant [ ] is not completely accurate
statement of the relevant law." Appeal Br. 9. We are not persuaded.
The patentability of a composition claim is based on the structure
claimed, not on how that structure is used. See Catalina 289 F.3d at 809.
Here, the claims are directed to a composition, a hybridization mixture that
is at a temperature between 85-95°C. As discussed above (see above I.), we
agree with Examiner that hybridization between the various nucleic acid
components is not required by the composition as claimed, all that is
required is that these components are mixed together and that these
components are brought to the recited temperature, even if only temporarily.
In other words, there is no requirement in the claim that these components
function in a particular way.
Examiner finds that the temperature "does not inherently change the
structure of the composition." See Final Act. 12. In other words, prior art
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compositions taught by W eisburg and Eli can readily be brought to a
temperature between 85-95°C without any detrimental effect to the
individual components.
Appellants contend that "'about' is properly construed as indicating
an insubstantial variation from the express range of 85°-95°C and should
not therefore be construed, as by the Examiner, as encompassing variations
exceeding 50% of the recited range so as to overlap with the range of Eli."
Appeal Br. 11.
We are not persuaded. As discussed above (see above I.), Examiner
finds that "Eli demonstrates that imidazole is known as a strong denaturant
that can be used between 75°C and 80, which is about 85°C." Final Act. 10;
Ans. 10. We agree that the term "about" in the context of the recited
hybridization mixture encompasses Eli's disclosed temperature range, and
further agree that the combination of W eisburg and Eli renders the claims
obvious. Appellants do not direct us to support in the Specification that
describes how to ascertain an insubstantial variation in the context of heating
a hybridization mixture. Indeed, the Specification shows that the
hybridization mixture in an assay works in a temperature range from 60 to
95°C. Specification figure 1; see id. 18, table 1 and 2. Given this disclosure
in the Specification, we find that the Examiner has reasonably interpreted
that the temperature range of "about 85°C to 95°C" overlaps with the
disclosure in Eli. Final Act. 1 O; Ans. 1 O; FF6.
In reaching the temperature limitation of the claim, Examiner
alternatively relies on ranges that do not overlap but are close enough that
one of skill in the art would have thought they would have the same
properties. See Ans. 9 ( citing Titanium Metals Corp. of Amer. v.Banner, 778
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F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). As we understand Examiner's
position, the temperature disclosed in Eli for denaturing DNA at about 80°C,
which is close enough to the presently claimed range of about 85-95°C
temperature, would render DNA denaturation at higher temperatures
obvious. We agree with the Examiner that one of ordinary skill in the art
would have understood that further increasing the temperature of an already
denatured product would result in a product that remains denatured.
We conclude that the evidence of record cited by Examiner supports a
prima facie case of obviousness with respect to claim 16. Next we address
Appellants' secondary considerations arguments.
Appellants contend that even if a prima facie case was made by the
Examiner, "the unexpected property supports patentability not only of the
method of detection but the composition used in the method of detection."
Appeal Br. 10, see id. 3 ( citing Example 5 "Despite these failures of
imidazole at low temperature, 85° to 95 °C temperatures generated
unexpectedly stellar results the 86 to 100% positive range for all three tested
strains"); see id. 4 (citing "rule 132 declarations by Dr. Reinhold Pollner
originally filed in the parent patent, US 7,993,853 on March 7, 2008,
December 19, 2008, and April 1, 2010"). "Neither Weisburg nor Eli
recognizes the fundamental problem the use of imidazole in combination
with high temperature addresses, namely a reduction in sensitivity due to the
presence of secondary or tertiary structure in target nucleic acids." Reply
Br. 4.
Examiner explains that Appellants' arguments are not considered
persuasive because even if the "wherein clause" of claim 16 is interpreted as
being a structural limitation of the claim, "the claim requires only one
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temperature" while the evidence presented requires two different
temperatures to arrive at the test results. Ans. 11. Examiner finds
Declaration- I 6 unpersuasive because "the declaration does not use any
denaturant in the assay and thus the assertion of improved result is not
unexpected, but an expected result." Ans. 1 7. Examiner finds that
Declaration-I "identifies the method alleged to provide an unexpected result
requires the use of specific capture and immobilized probes as well as
temperatures in addition to those of the claim. Thus the alleged unexpected
result is not consistent with the pending claim." Ans. 16.
As discussed above (see I.), we agree with Examiner that the claims
do not require any particular level of hybridization and therefore the
disclosures that rely on a particular methodology using a particular set of
probes is not commensurate in scope with the claims. As our reviewing
court has explained, it is well settled that "[ e ]vidence of secondary
considerations must be reasonably commensurate with the scope of the
claims. . . . This does not mean that an applicant is required to test every
embodiment within the scope of his or her claims." In re Kao, 639 F.3d
1057, 1068 (Fed. Cir. 2011). Rather, "[i]f an applicant demonstrates that an
embodiment has an unexpected result and provides an adequate basis to
support the conclusion that other embodiments falling within the claim will
behave in the same manner, this will generally establish that the evidence is
commensurate with scope of the claims." Id. Here, to the extent that any
results are unexpected, they are not commensurate in scope with the much
broader recitation of claim 16. As discussed above (see above I.), the claims
6 Declaration under 37 CPR 1.132 by Reinhold B. Pollner, Ph.D, signed
March 7, 2008 ("Declaration-I").
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recite a mixture of a variety of components at a particular temperature.
There is no requirement in claim 16 that the combination actually achieve a
particular result. Interpreting the claims as requiring a particular level of
hybridization impermissibly reads limitations from the Specification into the
claims. The composition as claimed can be completely denatured and still
fall within the scope of the claim. Accordingly, we agree with Examiner
that the evidence presented in the declaration is not commensurate in scope
with the present claims and, therefore, is insufficient to overcome the prima
facie case of obviousness.
Examiner finds that "Weisburg teaches heating and the presence of
detergent (see example 3) as well as denaturant. The using [ofJ detergent
alone is beyond the scope of the claims." Ans. 18 ( citing Weisberg Example
3). Examiner also finds Declaration-2 7 unpersuasive because it shows "that
[either] heat or imidazole alone do[ es] not work" and it is only when they
are applied in combination that the process captures more target nucleic
acid, but this does not establish that this combination is more sensitive "than
heat and the use of another denaturant." Ans. 18. Examiner acknowledges
that Declaration-3 8 "compares imidazole with a known denaturant,
formamide, which unlike imidazole, is commonly included in hybridization
mixtures." Ans. 19. Examiner nevertheless finds that the data in
Declaration-3 is also not persuasive because it relies on the use of "specific
probes and appear[ s] to require an additional temperature to those of the
7 Declaration under 37 CPR 1.132 by Reinhold B. Pollner, Ph.D, signed
Dec. 19, 2008 ("Declaration-2").
8 Declaration under 37 CPR 1.132 by Reinhold B. Pollner, Ph.D, signed
April 1, 2010 ("Declaration-3").
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claim." Id. We agree with Examiner that the data presented in these
declarations is not commensurate with the scope of the claims because the
claims do not require any particular level of hybridization. Indeed, the
claims can contain components that are all completely denatured at the
recited temperature and still fall within the scope of the claims.
Accordingly, we agree with Examiner that the evidence presented in the
declarations is not commensurate in scope with the present claims and
therefore not sufficient of overcome the prima facie case of obviousness
presented.
We conclude that the evidence cited by Examiner sufficiently
supports a prima facie case of obviousness with respect to claim 16.
Appellants have not provided sufficient rebuttal evidence that on balance
outweighs the evidence supporting Examiner's conclusion of obviousness
based on the claims as currently presented. Claims 18, 19, 21-26, 28, 29,
31-34, 37, and 38 were not separately argue and fall with claim 16. See 37
C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claim 16 as being indefinite under 35
U.S.C. § 112, second paragraph. Claims 18, 19, 21-26, 28, 29, 31-34, 37,
and 38 were not separately argued and fall with claim 16.
We affirm the rejection of claim 16 under 35 U.S.C. § 103(a) over
Weisburg and Eli. Claims 18, 19, 21-26, 28, 29, 31-34, 37, and 38 were not
separately argued and fall with claim 16.
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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
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