Ex Parte Burdinski et al

Patent Trial and Appeal Board

Oct 7, 2016

12744494 (P.T.A.B. Oct. 7, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
121744,494 05/25/2010 Dirk Burdinski
24737 7590 10/12/2016
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus A venue
Suite 340
Valhalla, NY 10595
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.
2007P01655WOUS 2778
EXAMINER
SCHLIENTZ, LEAH H
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
10/12/2016 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):
marianne.fox@philips.com
debbie.henn@philips.com
patti. demichele@Philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DIRK BURDINSKI, SANDER LANGEREIS and
JEROEN ALPHONS PIKKEMAAT
Appeal2015-003972
Application 12/744,4941
Technology Center 1600
Before ULRIKE W. JENKS, RICHARD J. SMITH and DAVID COTTA,
Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a contrast
agent for magnetic resonance imaging based on chemical exchange-
dependent saturation transfer. The Examiner rejected the claims on appeal
as anticipated and obvious.
We affirm.
1 According to Appellants, the real party in interest is Koninklijke Philips,
N.V. App. Br. 3.
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Application 12/744,494
STATEMENT OF THE CASE
Claims 1-16 are on appeal. 2 Claim 1 is illustrative and reads as
follows:
1. A contrast agent for Magnetic Resonance Imaging
(MRI) based on Chemical Exchange-dependent Saturation
Transfer (CEST), the agent comprising a non-spherical
carrier comprising a semipermeable shell, wherein the
shell comprises a paramagnetic compound, the shell
enclosing a cavity comprising an MR analyte, wherein the
semipermeable shell allows diffusion of the MR analyte
and the MR analyte is capable of diffusion through the
semipermeable shell, and wherein the cavity does not
comprise a paramagnetic shift reagent substantially
interacting with the analyte.
The claims stand rejected as follows:
Claims 1--4, 6-8, and 11-13 under 35 U.S.C. § 102(b) as unpatentable
over Li. 3
Claims 1--4, 6-8, and 11-14 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Li and Port. 4
Claims 1--4 and 6-14 under 35 U.S.C. § 103(a) as unpatentable over
the combination of Li, Port, and Viglianti. 5
2 Appellants' brief identifies only claims 1-14 as on appeal. App Br. 3.
However, Appellants appeal from and discuss a ground of rejection that
included claims 15 and 16. App. Br. at 14-15. Accordingly, we treat claims
15 and 16 as being part of this appeal.
3 Li et al., U.S. Patent No. 5,512,294, issued Apr. 30, 1996 ("Li").
4 Port, U.S. Patent Publication No. 2007/0292354 Al, published Dec. 20,
2007 ("Port").
5 Viglianti et al., U.S. Patent Publication No. 2004/0101969 Al, published
May 27, 2004 ("Viglianti").
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Claims 1--4, 6-8, and 11-14 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Lattuada, 6 and T erreno. 7
Claims 1-8 and 11-16 under 35 U.S.C. § 103(a) as unpatentable over
the combination of Lattuada, Terreno, Schroder8 and Driehuys. 9
REJECTION OF CLAIMS 1--4, 6-8 AND 11-13
AS ANTICIPATED BY LI
Appellants argue claims 1-4, 6-8 and 11-13 together as a group. We
designate claim 1 as representative.
The Examiner found that Li disclosed "liposomes [that] may be linked
to contrast ions for magnetic resonance imaging and radioisotope imaging."
Ans. 5. The Examiner determined that Li's paramagnetic liposome met all
of the limitations of claim 1. Ans. 2--4.
Appellants contend that Li does not disclose several of the limitations
of claim 1. Appellants contend that Li does not disclose a non-spherical
carrier. App. Br. 7. We disagree. Li states:
The size and shape of the paramagnetic
polymerized liposomes have been ascertained by
transmission electron microscopy and by atomic force
microscopy, as shown in FIGS. 7 and 8. They appear as
6 Lattuada et al., U.S. Patent Publication No. 2008/0317668 Al, published
Dec. 25, 2008 ("Lattuada").
7 Terreno et al., Highly Shifted LIPOCEST Agents Based on the
Encapsulation of Neutral Polynuclear Paramagnetic Shift Reagents, J.
Chem. Commun. 600-602 (2008) ("Terreno").
8 Schroder et al., Molecular Imaging Using a Targeted Magnetic Resonance
Hyperpolarized Biosensor, 314 Science 446--49, Oct. 20, 2006 ("Schroder").
9 Driehuys et al., U.S. Patent Publication No. 2004/0005273 Al, published
Jan. 8, 2004 ("Driehuys").
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prolate ellipsoids with minor axes on the order of the
membrane pore and major axes about 50 percent greater.
Li col. 11, 11. 62-67. An ellipsoid is not a sphere. Li's liposome thus meets
the "non-spherical carrier" limitation of claim 1.
Appellants also contend that Li does not disclose a cavity enclosed
within a semipermeable shell. App. Br. 7. We disagree. Li discloses a
bilayer liposome. Li col. 5, 11. 52-55. The Specification teaches that bilayer
liposomes enclose a cavity. Specification p. 5, 11. 28-30 ("Liposomes are
generally spherical vesicles comprising a bilayer membrane enclosing a
cavity."). The fact that Li does not use the word "cavity" in describing its
liposome does not mean that its liposome lacks a cavity, particularly given
the general teaching of the Specification that liposomes enclose cavities.
Appellants further contend that Li does not disclose that the cavity of
its liposome lacks a paramagnetic shift reagent as recited in claim 1. App.
Br. 8. The Examiner found that this limitation was met because the only
paramagnetic ions disclosed in Li are taught to be attached to the exterior
surface of the liposomes. Ans. 16-17 (citing Li col. 5, 11. 17-18). In
particular, the Examiner noted that Li did not disclose that a hydrophilic
shift agent was present in the core. Ans. 1 7. The Examiner also found that
both Li and Example 1 of the Specification disclose liposomes that
incorporate an amphiphilic metal chelate in the lipid shell. Id. at 19. Put
another way, the Examiner found that Li and Example 1 of the Specification
disclosed products that were substantially identical in structure or
composition. Id. Based on the substantial identity of embodiments and the
absence of any disclosure that Li's core includes a shift agent, the Examiner
determined that the burden had shifted to the Appellants to show differences
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between the claimed contrast agent and Li's liposome. Id. (citing In re Best,
562 F.2d 1252, 1255 (CCPA 1977)).
Appellants do not offer evidence that the cavity or core of Li's
liposome does, in fact, include a paramagnetic shift agent. Instead,
Appellants fault the Examiner for not proving the negative - i.e. the absence
of a shift agent. We find that a preponderance of the evidence supports the
Examiner's finding that the liposomes disclosed in Li do not include a
paramagnetic shift agent. That Li does not expressly state that there are no
paramagnetic ions in the core of its liposome should not be taken as an
indication that there are, in fact, paramagnetic ions present in the core. One
would expect that if paramagnetic ions were present in Li's core, Li would
say so. This is particularly true where Li expressly discloses that
paramagnetic ions are present on the exterior of its liposome. See, Li col. 5,
11. 17-18. To the extent Appellants contend that there are paramagnetic ions
in Li's core, it was Appellants burden to show that they are present. In re
Best, 562 F.2d at 1255; In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990).
Accordingly, we affirm the Examiner's rejection of claim 1 as
unpatentable over Li. Because they were not argued separately, claims 2--4,
6-8 and 11-13 fall with claim 1.
REJECTION OF CLAIMS 1--4, 6-8 AND 11-14 AS OBVIOUS OVER
THE COMBINATION OF LI AND PORT
Claim 14 reads in part, "A method of performing a CEST MRI scan
on a person, wherein CEST contrast agents according to claim 1 are brought
into body fluid of the person .... " The Examiner found that Li did not
"specifically recite using his elliposoidal [sic, ellipsoidal] liposomes ... in a
method of CEST MRI imaging on a person" as recited in claim 14. Ans. 6.
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The Examiner found, however that Port taught agents for CEST imaging.
The Examiner concluded:
Ans. 8.
It would have been obvious to one of ordinary skill
in the art at the time of the invention to employ the
nonspherical liposomes bearing a paramagnetic complex
in the liposome membrane taught by Li in methods of
CEST imaging when the teaching of Li is taken in view
of Port. One would have been motivated to do so
because both Li and Port are directed to MR imaging
using paramagnetic liposomes, and because Port teaches
that CES T provides the advantage of reducing the water
signal, which has been shown to occur when a proper
radiofrequency (rf) irradiating field is applied at the
resonance frequency of the exchangeable protons
saturating it. This results in a net decrease of the bulk
water signal intensity owing to a saturation transfer effect
(Port paragraph 0002-0003). One would have had a
reasonable expectation of success in using the
nonspherical liposomes taught by Li in methods of CEST
imaging because Port teaches that liposomes comprising
polymerizable lipids are suitable.
Appellants argue against this rejection on the ground that Li fails to
disclose "at least one feature of claim l" for the reasons discussed in
connection with the Examiner's first rejection. App. Br. 10. For the reasons
discussed above, we are not persuaded by these arguments. In addition,
Appellants contend that the Examiner's basis for combining Li and Port is
"improper" because:
[W]hile the Examiner did present a reason why one or
[sic, of] ordinary skill in the art would combine the
references, there is no articulated reasoning with some
rational underpinning to support the legal conclusion of
obviousness. In this case, there is no basis present as to
why it is necessary to reduce "the water signal, which has
been shown to occur when a proper radiofrequency (rf)
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irradiating field is applied at the resonance frequency of
the exchangeable protons saturating it;" or why is it
necessary to " ... decrease of the bulk water signal
intensity owing to a saturation transfer effect." As such,
the proffered reason to combined [sic] the references is
merely conclusory, and provides no evidence or analysis
that demonstrates why the requisite supposed reason
actually exists and that it would have been recognized by
one of ordinary skill in the art at the time the invention
was made.
Id. at 11. We disagree.
The Examiner explained that reducing water signal and decreasing the
bulk water signal intensity are "integral to CEST imaging." Ans. 20. The
Examiner was not required, as Appellants apparently contend, to explain in
detail how CEST imaging works and why it is necessary to reduce the water
signal and decrease the bulk water single intensity in order to generate a
CEST image. This is particularly true where CEST imaging appears to have
been known since at least 2000. Port ,-i 3 (citing publication on CEST
imaging from 2000).
Appellants further argue that the relevance of Port's teaching to Li is
unclear because Li does not disclose CEST contrast enhancement. Reply Br.
5. We are not persuaded. As the Examiner explained, Port's teaching is
relevant to Li because they both teach imaging using liposomes that incorporate
paramagnetic ions in the lipophilic membrane. See, Ans. 20. Port teaches an
approach for producing "very satisfying" CEST images. Port if 17. Port also
teaches that "water molecules encapsulated" in a liposome "with a shift agent
such as a lanthanide complex ... inserted in the lipophilic layer" - i.e.
liposomes like those disclosed in Li - can be used in its CEST imaging
approach. Id. iii! 17-20. Port and Li thus provide rational underpinnings for the
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Examiner's finding that the claimed contrast agent would have been obvious.
Appellants have not persuasively established otherwise. Accordingly, we agree
with the Examiner: "As liposomes incorporating lanthanide ions in the
lipophilic layer are taught for the intended use of CEST imaging, the skilled
artisan would have been motivated to have predictably used such liposomes as
a suitable encapsulating system in the methods of CEST imaging taught by
Port. ... " Ans. 20.
Accordingly, we affirm the Examiner's rejection of claim 14 as
unpatentable over the combination of Li and Port. We affirm the
Examiner's rejection of claims 1--4, 6-8, and 11-13 for the reasons
discussed in connection with the Examiner's first rejection.
REJECTION OF CLAIMS 1--4, 6-14 AS OBVIOUS OVER
THE COMBINATION OF LI, PORT AND VIGLIANTI
Claim 9 depends from claim 1 and adds the limitation "the agent
comprising a drug, and the carrier being adapted to allow release of the drug
through the application of energy." Claim 10 depends from claim 9 and
adds the limitation "wherein the carrier is a thermosensitive liposome."
The Examiner found that the combination of Li and Port did not
"teach that the contrast agents comprise a drug wherein the carrier is adapted
to allow release of the drug through the application of energy." Ans. 8. The
Examiner found that this feature was taught by Viglianti which disclosed
that "envirosensitive liposomes can be employed for in vivo monitoring of
drug release and distribution from an envirosensitive liposome using MRI."
Id. at 9. The Examiner concluded:
It would have been obvious to one of ordinary skill
in the art at the time of the invention to provide a
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Ans. 9-10.
therapeutic agent in the non-spherical paramagnetic
liposomal MRI agents taught by Li and Port when the
teaching of Li is taken in view of Viglianti. One would
have been motivated to do so because Viglianti teaches
that thermosensitive liposomes containing therapeutic
agent and contrast agent provide the advantage of
therapeutic treatment in addition to monitoring by MRI.
One would have had a reasonable expectation of success
in doing so because Viglianti readily teaches suitable
liposomal components for preparing liposomes having
the desired effect, and Port teaches that thermosensitive
liposomes are suitable (paragraph 0078,0081 ).
Appellants argue against this rejection on the ground that Li fails to
disclose "at least one feature of claim l" for the reasons discussed in
connection with the Examiner's first rejection. App. Br. 11. For the reasons
discussed above, we are not persuaded by these arguments. In addition,
Appellants contend that the Examiner's basis for combining Li, Port and
Viglianti is "improper" because:
[W]hile the Examiner did present a reason why one or
[sic, of] ordinary skill in the art would combine the
references, there is no articulated reasoning with some
rational underpinning to support the legal conclusion of
obviousness. In this case, there is no basis present as to
why it is necessary "to provide therapeutic a [sic] agent
in the non-spherical paramagnetic liposomal MRI
agents" or why the advantage gained by "thermosensitive
liposomes containing therapeutic agent and contrast
agent ... in addition to monitoring by MRI" would have
motivated one skilled in the art to make the combination
of Li, et al. and Viglianti. As such, the proffered reason
to combined [sic] the references is merely conclusory,
and provides no evidence or analysis that demonstrates
why the requisite supposed reason actually exists and
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that it would have been recognized by one of ordinary
skill in the art at the time the invention was made.
App. Br. 12. We disagree.
Viglianti discloses that tumors present "inherent perfusion
limitations" that hinder treatment and that "[t]he ability to monitor and/or
predict in vivo concentration distributions could improve treatment."
Viglianti ,-i 113. Viglianti teaches that this benefit - improved treatment - is
provided by "envirosensitive liposomes [that] can be employed for in vivo
monitoring of drug release and distribution from an envirosensitive liposome
using MRI." Id. Contrary to Appellants assertions, the potential for
improved treatment, provides a clear basis for combining Li, Viglianti and
Port.
Accordingly, we affirm the Examiner's rejection of claims 9 and 10 as
unpatentable over the combination of Li, Port, and Viglianti. We affirm the
Examiner's rejection of claims 1--4, 6-8, and 11-14 for the reasons
discussed in connection with the Examiner's first and second rejections.
REJECTION OF CLAIMS 1--4, 6-8, AND 11-14 AS OBVIOUS OVER
THE COMBINATION OF LATTUADA AND TERRENO
Appellants argue claims 1--4, 6-8, and 11-14 together as a group. We
designate claim 1 as representative.
The Examiner found that Lattuada disclosed paramagnetic liposomes
that act as CEST agents. Ans. 10. The Examiner found that Lattuada
disclosed all of the limitations of claim 1 with the exception that it did not
disclose non-spherical liposomes. Id. at 10-11. The Examiner found this
limitation present in Terreno, which disclosed that "nonspherical
paramagnetic liposomes as CEST imaging agents provided a significantly
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extended range of accessible irradiation frequency value compared to
spherical liposomes. Id. at 11. The Examiner concluded:
Ans. 11-12.
It would have been obvious to one of ordinary skill
in the art at the time of the invention to provide non-
spherical liposomes comprising a paramagnetic complex
incorporated in the membrane when the teaching of
Lattuada is taken in view of Terreno. [] Lattuada teaches
that paramagnetic complex can be encapsulated in the
aqueous cavity of the liposome (if hydrophilic), and/or
incorporated in the lipidic bilayer of the membrane (if
amphiphilic ). Accordingly, Lattuada teaches that an
encapsulated paramagnetic complex is not a necessary
component of the system, which meets the instant claim
limitation that the cavity does not comprise a
paramagnetic shift reagent substantially interacting with
the analyte. One would have been motivated to provide
such CEST agents comprising liposomes having a
paramagnetic complex incorporated in the lipidic bilayer
of the membrane in nonspherical form with a reasonable
expectation of success because Lattuada teaches that the
chemical shift of the water proton is affected by the
shape of the liposome (paragraph 0177), and because
T erreno teaches that nonspherical paramagnetic
liposomes as CEST imaging agents provided a
significantly extended range of accessible irradiation
frequency value compared to spherical liposomes.
Appellants argue that Lattuada does not preclude the presence of a
paramagnetic shift agent in the cavity as required by claim 1. More
particularly, Appellants argue that Lattuada's disclosure that "a
paramagnetic complex can be encapsulated in the aqueous cavity of the
liposome (if hydrophilic) and/or incorporated in the lipidic bilayer of the
membrane (if amphiphilic )" does not meet the requirement of claim 1 that
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"the cavity does not comprise a paramagnetic shift reagent." App. Br. 12-
13. We disagree. As the Examiner correctly explained in the Answer:
Ans. 22.
The recitation of a paramagnetic complex encapsulated in
the aqueous cavity "and/or" incorporated in the lipidic
bilayer of the membrane indicates that the paramagnetic
complex can be present 1) in both aqueous cavity and
incorporated in the lipidic bilayer or 2) in the aqueous
cavity of the liposome only, or 3) incorporated in the
lipidic bilayer only. Accordingly, a skilled artisan
desiring to provide a paramagnetic complex incorporated
in the lipidic membrane (in the alternative to in the
aqueous cavity) meets the instant claim limitation that the
cavity does not comprise a paramagnetic shift reagent
substantially interacting with the analyte.
Appellants contend that the Examiner's basis for combining Lattuada
and T erreno is "improper" because:
[W]hile the Examiner did present a reason why one or
[sic, of] ordinary skill in the art would combine the
references, there is no articulated reasoning with some
rational underpinning to support the legal conclusion of
obviousness. In this case, there is no basis present as to
why it is useful "such CEST agents comprising
liposomes having a paramagnetic complex incorporated
in the lipidic bilayer of the membrane in nonspherical
form." As such, the proffered reason to combined [sic]
the references is merely conclusory, and provides no
evidence or analysis that demonstrates why the requisite
supposed reason actually exists and that it would have
been recognized by one of ordinary skill in the art at the
time the invention was made.
App. Br. 13. We disagree.
Terreno discloses "[m]ore recently, a significant extension of the
accessible L'1intralipo values for LIPOCEST agents has been achieved by
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exploiting the bulk magnetic susceptibility (BivIS) shift contribution; this
requires the compartmentalization of the paramagnetic SR in non-
spherical liposomes." Terreno 600 (emphasis added). Terreno then
proceeds to describe multiple advantages of extended L'1intralipo values,
including:
(i) the exploitation of faster exchange rates that in tum,
will result in more efficient saturation transfer effects; (ii)
the reduction of artifacts arising from field
inhomogeneity and spillover effects that are particularly
relevant when the signal of the exchanging proton pool
lies close to the bulk water signal; (iii) the selective
detection of different LIPOCEST probes simultaneously
present in the same region of interest, (iv) the
negligibility of contributions arising from endogenous·
proteins or solid-like mobile protons immobilized in
tissue (conventional magnetization transfer contrast).
Id. Contrary to Appellants' assertions, Terreno's teaching that non-spherical
liposomes are required in order to obtain the multiple benefits of extended
L'1intralipo values provides a clear basis as to why it would be useful to use a
non-spherical form of the liposomes disclosed in Lattuada.
Accordingly, we affirm the Examiner's rejection of claim 1 as
unpatentable over the combination of Lattuada and Terreno. Because they
were not argued separately, claims 2--4, 6-8, and 11-14 fall with claim 1.
REJECTION OF CLAIMS 1-8 AND 11-16 AS OBVIOUS OVER
THE COMBINATION OF LATTUADA, TERRENO, SCHRODER AND
DRIEHUYS
Claims 5, 15, and 16 require that the analyte be hyperpolarized nobel
gas (claim 5 specifies that the gas be xenon or helium). The Examiner found
that the combination of Lattuada and Terreno "do not teach hyperpolarized
xenon as the nuclei which is detected by CEST MRI." Ans. 12. The
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Examiner found, however, that Schroder taught the detection ofbiosensor-
bound xenon using a HYPER-CEST imaging method. Id. at 12-13. The
Examiner concluded:
Id. at 13.
It would have been obvious to one of ordinary skill
in the art at the time of the invention to substitute
hyperpolarized xenon for water proton as the nuclei
detectable by CEST MRI in the non-spherical
paramagnetic liposomes LIPOCEST MRI agents taught
by Lattuada and T erreno when the teachings of Lattuada
and Terreno are taken in view of Schr[o]der. One would
have been motivated to do so, with a reasonable
expectation of success, because Schr[o]der teaches that
use the signal of free hyperpolarized xenon to
dramatically alter the xenon biosensor signal via CEST is
10,000 times more sensitive than previous CEST
methods and other molecular magnetic resonance
imaging techniques (abstract).
Appellants argue against this rejection on the same grounds that
Appellants contested the Examiner's rejection based on the combination of
Lattuada and Terreno. App. Br. 14. For the reasons discussed above, we are
not persuaded by these arguments. In addition, Appellants contend that the
Examiner's basis for combining Lattuada, Terreno and Schroder is
"improper" because:
[W]hile the Examiner did present a reason why one or
[sic, of] ordinary skill in the art would combine the
references, once again, there is no articulated reasoning
with some rational underpinning to support the legal
conclusion of obviousness. In this case, there is no basis
present as to why it is useful to ["]provide the signal ... to
dramatically alter the xenon biosensor signal via CEST is
10,000 times more sensitive than previous CEST
methods and other molecular magnetic resonance
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imaging techniques." As such, the proffered reason to
combined [sic] the references is merely conclusory, and
provides no evidence or analysis that demonstrates why
the requisite supposed reason actually exists and that it
would have been recognized by one of ordinary skill in
the art at the time the invention was made.
App. Br. at 15. We disagree.
Schroder discloses a MRI approach in which xenon atoms are linked
to biomolecular targets. Schroder discloses:
This technique uses the signal of free hyperpolarized
xenon to dramatically amplify the sensor signal via
chemical exchange saturation transfer (CEST). Because it
is~ 10,000 times more sensitive than previous CEST
methods and other molecular magnetic resonance
imaging techniques, it marks a critical step toward the
application of xenon biosensors as selective contrast
agents in biomedical applications.
Schroder Abstract. Contrary to Appellants' assertions, Schroder's teaching
that using a xenon labeled biosensor in connection with CEST imaging is"~
10,000 times more sensitive than previous CEST methods" provides a clear
basis as to why it would be useful to use xenon in the liposome of Lattuada.
Accordingly, we affirm the Examiner's rejection of claims 5, 15, and
16 as unpatentable over the combination of Lattuada, Terreno, and Schroder.
We affirm the Examiner rejection of claims 1-4, 6-8, and 11-14 for the
reasons discussed in connection with the Examiner's rejection of those
claims over the combination of Lattuada and Terreno.
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SUivIIvIAR Y
For these reasons and those set forth in the Examiner's Answer, the
Examiner's final decision to reject claims 1-16 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a)(l).
AFFIRMED
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