Ex Parte OWEN et al

Patent Trial and Appeal Board

Mar 18, 2019

13105726 (P.T.A.B. Mar. 18, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/105,726 05/11/2011 Richard Harley Grenville OWEN
22428 7590 03/20/2019
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
093840-0103 3819
EXAMINER
EISEMAN, ADAM JARED
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
03/20/2019 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARD HARLEY GRENVILLE OWEN,
STEPHEN BLATCHER, STEW ART MADDISON FOX, and
MARTIN LAWRENCE HUGHES
Appeal2017-006328
Application 13/105,726
Technology Center 3700
Before BENJAMIN D. M. WOOD, ANNETTE R. REIMERS, and
SEAN P. O'HANLON, Administrative Patent Judges.
O'HANLON, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Richard Harley Grenville Owen et al. ("Appellants") 1 appeal under 35
U.S.C. § 134(a) from the Examiner's decision, as set forth in the Final
Office Action dated March 23, 2016 ("Final Act."), rejecting claims 1-15
1 The Appeal Brief identifies PlaqueTec Limited as the real party-in-interest.
Appeal Br. 2.
Appeal2017-006328
Application 13/105,726
and 22 (all pending claims). Appellants' representative presented oral
argument on March 7, 2019. We have jurisdiction over this appeal under 3 5
U.S.C. § 6(b). We AFFIRM.
SUMMARY OF THE INVENTION
The claimed subject matter "relates to a catheter for insertion into a
blood vessel allowing blood samples to be taken." Spec. 1. Claims 1, 5, 11,
and 13 are independent. Claim 1, reproduced below from page 25 (Claims
Appendix) of the Appeal Brief, is illustrative of the claimed subject matter:
1. A method for generating a data profile for one or more
biomarkers at a site of interest in a blood vessel, comprising the
steps of:
analyzing a plurality of blood samples obtained from
respective locations along a length of the blood vessel;
measuring the concentration of the one or more
biomarkers in each of the samples;
generating a data profile of the concentration levels for
the one or more biomarkers along the length of said blood
vessel; and
obtaining the plurality of blood samples having a volume
between about 10µ1 and 50µ1 from the respective locations
along the length of the blood vessel;
wherein the step of obtaining the plurality of blood
samples comprises obtaining the plurality of blood samples
substantially simultaneous! y.
REFERENCES
The Examiner relies on the following prior art references in rejecting
the claims on appeal:
Wallace
Brown
US 2002/0026174 Al
WO 2004/010874 Al
2
Feb.28,2002
Feb. 5,2004
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Application 13/105,726
REJECTIONS
I. Claims 1-15 and 22 stand rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite.
II. Claims 1-15 and 22 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Brown and Wallace.
ANALYSIS
Rejection I
The Examiner determines that "[t]he term 'about' in claims 1, 5, 11
and 13 and claims dependent therefrom, is a relative term which renders the
claim indefinite." Final Act. 2. According to the Examiner, "[t]he
[S]pecification does not give any definition to the term about, and as such it
is unclear as to what margin of error or tolerance is applied to the claimed
ranges, thus leaving the claims indefinite." Id. at 3; see also Ans. 8-10.
Appellants traverse, arguing that "the term 'about' as recited in claims
1, 5, 11 and 13 should be afforded its plain and ordinary meaning of
'approximately"' and that "those of ordinary skill in the art would have
known the approximate volume of a sample needed for a diagnostic
chemistry process." Appeal Br. 7 (citing MPEP § 2173.05(b)(III)).
Appellants note that "[t]he term 'about' is routinely used in patent claims,
and the courts routinely construe it as plain meaning [sic], accordingly to
how 'a person having ordinary skill in the art' would understand it." Reply
Br. 3.
"[T]he word 'about' does not have a universal meaning in patent
claims, and [its] meaning depends on the technological facts of the particular
case." Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1217 (Fed. Cir.
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1995). Use of the word about as part of a numeric range avoids a strict
numerical boundary to the specified parameter. Cohesive Techs. Inc. v.
Waters Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008). In determining the
range encompassed by the term about, one must consider the context of the
term as it is used in the specification and claims of the application. Pall, 66
F.3d at 1217.
Here, the Specification discusses the sample volume as follows:
"Many diagnostic chemistry processes require samples of approximatefv
50 µl and, hence, for many embodiments each discrete sample is
substantially of this value. However, the discrete samp1es may be between
0.1 µ.l and 100 µL more preferably between 20 µland 50 ~tL" Spec. 6
( emphases added). 'Thus, the Specification supports A.ppe11ants' assertion
that the term about as used in the claims means "approximately." See
Appeal Br. 7; see also Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d
1364, 1369 (Fed. Cir. 2005) (recognizing the ordinary meaning of about to
be approximately).
The Examiner appears to apply a per se rule that because the claims
include the word about, the claims are indefinite. Such an approach is
improper, as it is well established that the use of relative terminology in
claim language does not automatically render the claim indefinite. See, e.g.,
Seattle Box Co., Inc. v. Indus. Crating & Packaging, Inc., 731 F .2d 818, 826
(Fed. Cir. 1984). Rather, the correct test is whether one of ordinary skill in
the art would understand what is claimed when the claim is read in light of
the specification. Id. As set forth above, one of skill in the art would
understand that "a volume between about 1 Oµl and 50~11'' means a volume
between approximately 10 µland 50 µ1; in other words, Appellants' "use of
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Application 13/105,726
the term 'about' shows that [Appellants] did not intend to limit the claimed
ranges to their exact end-points." In re Harris, 409 F.3d 1339, 1343 (Fed.
Cir. 2005).
Accordingly, we do not sustain the rejection of claims 1-15 and 22 as
being indefinite.
Rejection II
Claims 1, 2, 4---6, 9, 11, 13, 15, and 22
Appellants present arguments for patentability of independent claims
1, 5, 11, and 13 collectively. Appeal Br. 7-23. We select claim 1 as
representative and treat the other claims as standing or falling with
representative claim 1. See 37 C.F.R. § 4I.37(c)(l)(iv).
The Examiner finds that Brown discloses a method substantially as
recited in independent claim 1, including, inter alia, obtaining a plurality of
fluid samples simultaneously, but "does not explicitly disclose the use of the
device in a blood vessel, or measuring the concentration of biomarkers in
each of the samples." Final Act. 3-5. The Examiner further finds that "in
Brown[']s disclosure [ofJ map[ping] the variation of characteristics in the
samples along a linear direction, analysis would inherently need to be
performed on the samples to obtain the characteristics." Id. at 5. The
Examiner reasons that it would have been obvious to a skilled artisan "that
concentration of biomarkers and analytes falls under Brown[']s description
of analysis of the samples which includ[ e] diagnostic, chemical, genomic,
and visual." Id. The Examiner finds that Brown discloses the sample
volume may range from 1 pl to 100 µl, and determines that "Brown's range
encompasses [Appellants'] claimed range of 10 µ1- 50 µland as such would
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Application 13/105,726
have been obvious to one of ordinary skill in the art at the time of the
invention to choose a volume within the claimed range." Id. at 6 ( citing
Brown, 10:5---6). The Examiner determines that Appellants' Specification
"does not provide a specific novel technical advantage to the use of the
[recited] range," and, thus, selection of the recited range is an obvious design
choice. Id.
The Examiner finds that Wallace discloses a method of using a
sampling device for sampling in a blood vessel, and reasons that it would
have been obvious to one of ordinary skill in the art "to use Brown's device
to collect fluid samples from a blood vessel as taught by Wallace in order to
obtain a plurality of fluid blood samples along the length of a blood vessel."
Id. at 4--5.
Appellants provide a number of arguments traversing the rejection.
Appeal Br. 7-23. First, Appellants argue that Brown is non-analogous and,
therefore, cannot properly be used in an obviousness rejection. Id. at 8-16.
Appellants cite extensively to the Declaration of Dr. Stephen Blatcher
("Blatcher Deel."), one of the inventors. Id. A reference qualifies as prior
art for a determination under § 103 when it is analogous to the claimed
invention. In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992).
Two separate tests define the scope of analogous prior art:
(1) whether the art is from the same field of endeavor,
regardless of the problem addressed, and (2) if the reference is
not within the field of the inventor's endeavor, whether the
reference still is reasonably pertinent to the particular problem
with which the inventor is involved.
In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (citing In re Deminski,
796 F.2d 436,442 (Fed. Cir. 1986)). The field of endeavor is determined
"by reference to explanations of the invention's subject matter in the patent
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Application 13/105,726
application, including the embodiments, function, and structure of the
claimed invention." Id.; see a !so l)en1.i ns!d, 796 F .2d at 442 (finding that if a
prior art reference discloses essentially the same structure and function as
the invention; it is likely in the same field of endeavor).
Appellants argue that Brown is from a different field of endeavor
because "[t]he claimed invention is directed to various methods that include
collecting blood samples," and "Brown is directed to collection of tissue
biopsies." Appeal Br. 8-9; see also Blatcher Deel. ,r,r 5-8. Appellants argue
that Brown's device "includes a sharp tip 52 ... [that] is completely
unsuitable for the claimed invention, which is channeled through a blood
vessel for sampling the blood." Appeal Br. 9 (citing Brown, 7: 10); see also
Blatcher Deel. ,r,r 9-12. Appellants argue that "the device in Brown allows
for portions that 'deliberately break off during use', which is completely
incompatible with being located in a blood vessel." Appeal Br. 9 ( citing
Brown, 8:14--19); see also Blatcher Deel. ,r 12. Appellants argue that
"Brown discloses a preferred sampling volume of less than 1.2 cubic
millimeters," which "is far too small for the types of diagnostic chemistry
analysis facilitated by the present invention." Appeal Br. 9 (citing Brown,
2:13, 5:26-27); see also Blatcher Deel. ,r 14. Appellants reproduce several
portions of the Blatcher Declaration, and argue that the Examiner failed to
consider the Blatcher Declaration. Appeal Br. 10-14.
We are not persuaded by Appellants' arguments, which
mischaracterize Brown's catheter. Contrary to Appellants' assertion that
Brown is "directed to collection of tissue biopsies" (id. at 9; see also
Blatcher Deel. ,r 8), Brown repeatedly discloses collection of fluid samples.
For example, Brown discloses that the internal vacuum of its vacuum
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Application 13/105,726
sampling device embodiment "draws either tissue or fluid from the exterior
of the chamber 3 into the chamber 3." Brown, 9:15-16 (emphasis added);
see also id. at 12: 19-21 ("mechanisms for collecting samples of tissue or
fluids" (emphasis added)), 13:5 (contrasting biopsy and sampling). Contrary
to the assertions of Appellants' declarant (see Blatcher Deel. ,r 9), this
embodiment does not "need" material to be cut or include a blade; rather,
Brown discloses that the covering material can be contoured to cut through
material drawn into the cavity (Brown, 9 :24--26), which would be
unnecessary for collecting fluid samples, and the referenced blade pertains to
"[a]n additional embodiment" (id. at 9:31). Brown also refers to its device
as "a biopsy and/or fluid sampling device." Id. at 1:30 (emphasis added).
Thus, like Appellants' device, Brown discloses a catheter for collecting fluid
samples.
Regarding the "sharp tip 52" cited by Appellants, Brown discloses:
"The catheter 50 includes a distal insertion end 52 and sampling devices 54.
The distal end 52 is a sharp or pointed end that is inserted into the subject
requiring removal of tissue or fluid samples." Id. at 7:9-11. That Brown
uses a sharp or pointed tip does not differentiate Brown's field of endeavor
from that of Appellants' claimed invention. Rather, like Appellants' device,
Brown discloses a medical catheter for insertion into a patient for biopsy or
other purposes. See id. at 7: 8-9.
Regarding Appellants' assertion that Brown allows for portions to
deliberately break off, Brown discloses that its sampling devices are
fabricated with biodegradable polymers, and that the use of such polymers
"allows implementations of this invention with portions that deliberately
break off during use, are left within the body, and cause no harm." Brown,
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8:14--16. Continuing, Brown discloses that "[t]he sampling devices 54 need
not be fabricated with biodegradable materials; however, use of
biodegradable materials removes the danger associated with portions that
break or fail during use." Id. at 8: 17-19. Thus, Brown contemplates
implementations of its device that have portions that deliberately break off,
but does not require such implementations as suggested by Appellants. A
skilled artisan would not use such a frangible implementation where it would
be undesired or dangerous to the patient. See KSR Int 'l 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.").
Regarding the volume of Brown's sampling chambers, Appellants
focus on the preferred volume to the exclusion of Brown's full disclosure.
As correctly noted by the Examiner (see Final Act. 6, 10; Ans. 14), Brown
discloses that"[ v ]olumes of such sampling chambers range from as small as
about a picoliter or less and as large as about a few hundred microliters
[(µl)] or more." Brown, 10:5---6. Thus, Brown discloses a volume ranging
from 1x10-12 liter to at least 1x10-4 liter, which encompasses the volume
range recited by Appellants.
The additional assertions made by Appellants' declarant similarly fail
to persuade us that Brown is not analogous to the claimed invention. For
example, the declarant' s characterizations of Brown's catheter as being
"stiff' and "inflexible" (see Blatcher Deel. ,r,r 10, 12) are unsupported by
evidence or persuasive technical reasoning, and the Examiner does not
suggest reusing Brown's catheter (see id. ,r 13). We additionally note that
Dr. Blatcher is also an Inventor/ Appellant and, as such, the Declaration is
less persuasive than that of a disinterested person. See In re McKenna, 203
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F.2d 717, 720 (CCPA 1953) ("[A]n affidavit by an applicant or co-applicant
as to the advantages of his invention is less persuasive than one made by a
disinterested person.").
In view of the foregoing, we determine that a preponderance of the
evidence supports the Examiner's determination that Brown is analogous to
the claimed invention. See Ans. 10-11. Because both Appellants' method
and Brown's device are directed to medical catheters for insertion into a
patient for obtaining fluid samples, Brown is in the same field of endeavor
as the claimed subject matter.
Appellants next argue that Brown does not disclose "the use of the
device for sampling blood." Appeal Br. 16; see also Reply Br. 12.
According to Appellants, "Brown is directed to removing solid tissue or
fluid using 'scrapping or cutting using a jaw or knife mechanism,"' and
"[t]he use of sharp or cutting edges is completely unsuitable for the claimed
invention." Appeal Br. 16 ( citing Brown, 3:5---6, 7: 10).
We are not persuaded by Appellants' arguments. As noted above,
Brown discloses a vacuum sampling device embodiment that draws fluid
into its chambers and that does not use a jaw or knife mechanism.
Additionally, as correctly noted by the Examiner (see Final Act. 3--4; Ans.
15-17), Brown discloses that "[t]he multiple sampling devices are
positioned along the outer diameter of the shaft portion of a single catheter
or other device, and samples are collected and stored in respective chambers
of the sampling devices." Brown, 1:33-2:2; see also id. at Fig. 1.
Appellants next argue that "[ o ]ne of ordinary skill in the art would not
have modified the method of Brown to insert the catheter into a blood vessel
to obtain a blood sample." Appeal Br. 18. Appellants argue that "[t]he
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Application 13/105,726
Brown catheter is completely unsuitable for blood sampling" (id. ( citing
Blatcher Deel. ,r 10)) and, because "Wallace is directed to a catheter used to
enlarge the blood vessel, ... one [ ofJ ordinary skill in the art would not have
turned to Wallace for any disclosure or teaching suggesting to use the device
disclosed by Brown in a blood vessel" (id. at 19). Continuing, Appellants
argue that because "[t]he catheter of Brown was suitable for its purpose
( e.g., collecting fluid samples from diseased areas) ... there would have
been no reason for one of ordinary skill in the art to modify the catheter of
Brown to collect blood samples." Id. Appellants argue that "neither Brown
nor Wallace disclose how to use the microminature manufacturing
technologies (Brown at p. 1) to make a catheter having the necessary
dimensions to be inserted into a blood vessel." Id.
We are not persuaded by Appellants' arguments. The assertion that
Brown's device is unsuitable for use in a blood vessel is premised on Dr.
Blatcher' s characterization of the Brown catheter as being stiff. Id. at 18
( citing Blatcher Deel. ,r 10). However, as noted above, the declarant does
not provide an evidentiary basis for this conclusory assertion. As for
Brown's "pointed tip," the Examiner modifies Brown's device "as taught by
Wallace," which discloses a catheter having distal end 40 designed to be
pushed through an artery. Final Act. 4--5; Wallace ,r 28, Fig. 6; see also
KSR, 550 U.S. at 421. As correctly noted by the Examiner, and as discussed
above, Brown discloses the collection of fluid samples from a patient.
Appellants fail to apprise us of error in the Examiner's determination that
blood qualifies as such a fluid. See, e.g., Final Act. 9-10.
Regarding Appellants' arguments regarding the manufacturing of
Brown's modified device, Brown does not require any specific
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manufacturing method. The assertion that Brown's device would require
"significant re-engineering" is premised on Dr. Blatcher' s characterization
of the Brown catheter as being inflexible. Appeal Br. 19 ( citing Blatcher
Deel. ,r,r 12-13). However, as noted above, the declarant does not provide
an evidentiary basis for this conclusory assertion. Moreover, as flexible
vascular catheters are well known, as evidenced, for example, by Wallace,
Appellants fail to persuade us that forming Brown's device of a flexible
material would be beyond the skill set of a person of ordinary skill in the art.
Appellants next acknowledge that "Brown ... contains a general
reference to the volume of a sampling chamber wherein the volumes 'range
from as small as a picoliter or less and as large as about a few hundred
microliters or more,"' but argue that "[t]here is no specific teaching of the
claimed range." Appeal Br. 20. Appellants cite paragraph 14 of the
Blatcher Declaration as establishing "evidence ... showing that [the]
claimed range is critical for intra vascular blood sampling and analysis." Id.
at20-2I.
We are not persuaded by Appellants' arguments. As noted above,
Brown's disclosed range fully encompasses the recited range. As such, the
Examiner has established the recited range to be prima facie obvious. See In
re Wertheim, 541 F.2d 257,267 (CCPA 1976).
When an applicant seeks to overcome a prima facie case of
obviousness by showing improved performance in a range that
is within or overlaps with a range disclosed in the prior art, the
applicant must "show that the [ claimed] range is critical,
generally by showing that the claimed range achieves
unexpected results relative to the prior art range."
In re Geisler, 116 F.3d 1465, 1469-70 (Fed. Cir. 1997) (modification in
original) (quoting In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990)).
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Appellants have not made any such showing. The cited declaration
testimony of Dr. Blatcher is of no avail, as Dr. Blatcher relies on the smaller
preferred volume of less than 1.2 µl rather than the full disclosure of Brown.
See Blatcher Deel. ,r 14. Notably, Dr. Blatcher testifies that a sample size of
1.2 µl is too small for certain (unrecited) blood analysis techniques, which is
unpersuasive of the larger volumes disclosed by Brown. Id.
Finally, Appellants argue that Brown does not disclose simultaneous
sampling. Appeal Br. 21-22. According to Appellants, "the only
application envisaged [in Brown] where only fluids are collected is one in
which the device is left in situ for some time and the ports are opened in
sequence to collect a series of fluid samples over time, rather than
simultaneously." Id. at 22 (referring to Brown, 6:7-10).
Appellants' arguments are in direct contrast to the disclosure of
Brown, and, therefore, are unpersuasive. As discussed above, Brown
repeatedly discloses collection of fluid samples. Brown further discloses
that multiple samples can be collected simultaneously. See, e.g., Brown
5:20-21 ("The plurality of sampling devices are activated simultaneously
such that multiple samples are achieved simultaneously."), 7:31-32 ("The
sampling devices 54 are activated to extract samples simultaneously or
separated in time.").
Accordingly, for the foregoing reasons, we sustain the rejection of
claims 1, 5, 11, and 13, and their dependent claims 2, 4, 6, 9, 15, and 22,
which are not argued separately, as being unpatentable over Brown and
Wallace.
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Claims 3, 7, 8, and 10-14
In addressing claims 3, 7, 8, and 10-14, the Examiner finds that
"Brown discloses mapping variations in the characteristics of samples along
a line or direction to evaluate the extent of change of sample characteristics
and further uses an example of measuring tumor growth." Final Act. 7. The
Examiner notes that "Brown discloses testing samples for diagnostic,
genomic, chemical and other analytical methods," and reasons, therefore,
that "it would have been obvious to one of ordinary skill in the art at the
time of the invention to test the samples by known methods for different
biomarkers/ characteristics of the samples depending on the disease/injury
the user is studying and/or treating." Id. The Examiner finds that Brown's
disclosure of mapping inherently discloses performing analyses on the
collected samples. Id. at 5. The Examiner reasons that a skilled artisan
would understand "that concentration of biomarkers and analytes falls under
Browns description of analysis of the samples which includ[ e] diagnostic,
chemical, genomic, and visual." Id.
Appellants contest the rejection of claims 3, 7, 8, and 10-14, arguing
that "[t]he Examiner's general contention regarding 'samples' is
inapplicable to the claims, which are directed specifically to testing blood
samples. Nowhere does Brown disclose testing blood samples for
determining cardiovascular health." Appeal Br. 23.
Appellants' arguments are not persuasive. As noted above, Brown
discloses the collection of fluid samples from a patient and Appellants have
not persuasively explained why blood would not qualify as such a fluid.
Brown further discloses:
The use of a plurality of sampling devices positioned along the
perimeter of the catheter provides multiple samples with similar
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dimensions. The collection of multiple, similarly-sized samples
permits the automation of sample analysis, whether chemical,
visual, or genomic. In addition, the collection of multiple
samples permits the mapping of tissue spatially with a higher
resolution ....
Brown, 6:4--8. Brown further discloses that the "sampling devices can be
placed in a linear array along a biopsy device and then deployed
simultaneously to map the variation of tissue in a given line or direction."
Id. at 12:22-24. As acknowledged by Appellants (see, e.g., Appeal Br. 11
( quoting Batcher Deel. ,r 8)), Brown discloses that its fluid and tissue
sampling can be used in the field of cardiology. Id. at 1: 13-15. Appellants'
declarant testifies that "analysis of blood proteins (i.e., cytokines) and lipids,
which are considered to be the most important analytes for assessing disease
state in cardiology," is "conventional." Blatcher Deel. ,r 14.
Thus, we determine that a preponderance of the evidence supports the
Examiner's determination that the recited testing of blood samples would
have been obvious in view of Brown and Wallace. To the extent Appellants
assert new arguments in the Reply Brief that were not included in the Appeal
Brief and are not responsive to a new argument raised in the Answer, such
arguments are untimely and will not be considered, in that Appellants fail to
make a good faith showing why they could not have been timely presented
in the Appeal Brief. See 37 C.F.R. § 4I.41(b)(2). Accordingly, we sustain
the rejection of claims 3, 7, 8, and 10-14 as being unpatentable over Brown
and Wallace.
DECISION
The Examiner's decision to reject claims 1-15 and 22 as being
indefinite is reversed.
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The Examiner's decision to reject claims 1-15 and 22 as being
unpatentable over Brown and Wallace is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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