Ex Parte Brey et al

Patent Trial and Appeal Board

Mar 20, 2017

12633631 (P.T.A.B. Mar. 20, 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.
12/633,631 12/08/2009 Robert N. Brey 502.214US 6031
90187 7590 03/20/2017
T .p.wis Knhn & Walker T T P EXAMINER
15030 Avenue of Science ROBINSON, LISBETH C
Suite 201
San Diego, CA 92128 ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
03/20/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT N. BREY, GEORGE B. McDONALD, and
CHRISTOPHER SCHABER1
Appeal 2016-001026
Application 12/633,631
Technology Center 1600
Before ELIZABETH A. LaVIER, RICHARD J. SMITH, and
RYAN H. FLAX, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
of treating tissue damage resulting from exposure to lethal amounts of
radiation. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is Soligenix, Inc.
(Appeal Br. 3.)
Appeal 2016-001026
Application 12/633,631
STATEMENT OF THE CASE
Claims on Appeal
Claims 1,4, 5, 10, 13, and 15—17 are on appeal. (Corrected Claims
App., dated April 20, 2015.) Claims 1 and 5 are illustrative and read as
follows (emphases added):
1. A method of treating the severity of cellular and tissue
damage due to increased rate of epithelial apoptosis in a subject
resulting from exposure to lethal amounts of radiation
consisting of administering to the subject an effective amount
of topically active corticosteroid beclomethasone dipropionate
in an oral formulation that releases beclomethasone
dipropionate locally in the small bowel sufficient to expose a
metabolite thereof selected from the group consisting of
beclomethasone-17-monopropionate and 21-beclomethasone
monopropionate to damaged epithelial cells such that epithelial
apoptosis is disrupted.
5. A method for using a pharmaceutical composition for
ameliorating or treating damage to the lining of the alimentary
tract of a patient wherein the damage is a result of the patient’s
exposure to lethal amounts of radiation consisting of:
a. ) administering an effective amount of topically active
corticosteroid beclomethasone dipropionate or metabolite
thereof selected from the group consisting of beclomethasone-
17-monopropionate and 21-beclomethasone monopropionate in
oral dosage form wherein the effective amount is 8 mg/day; and
b. ) administering a second compound that is intended to
treat another cellular aspect of tissue damage, wherein the
second compound is selected from the group consisting of
growth factors, regulator molecules, keratinocyte growth factor
(KGF), R-spondin-1, R-spondin-2, R-spondin-3, R-spondin-4,
somatostatin, octreotide, gastrin, Ghrelin, inhibitors of COX-2,
antioxidants, vitamin E, sucralfate, lysophosphatidic acid,
lysophosphatidic acid (LPA-2) receptor, and amifostine;
wherein the pharmaceutical composition is administered
to patient within at least 24 hours following radiation exposure.
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Examiner’s Rejections
1. Claims 5, 10, 13, and 15—17 stand rejected under 35 U.S.C. § 112(a)
or 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the
written description requirement (new matter). (Final Act. 3—5.)2
2. Claims 1 and 10 stand rejected under pre-AIA 35 U.S.C. § 102(b) as
anticipated by Dor BioPharma,3 as evidenced by orBec® NDA.4 (Id. at 5—
6.)
3. Claims 1, 4, 5, 10, and 13 stand rejected under pre-AIA 35 U.S.C.
§ 103(a) as unpatentable over Dor BioPharma, as evidenced by orBec®
NDA, in view of Stergiopoulos.5 (Id. at 10-15.)
4. Claims 10 and 15 stand rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Dor BioPharma, as evidenced by orBec® NDA, in view
of Jacob.6 (Id. at 15—17.)
5. Claims 10 and 16 stand rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Dor BioPharma, as evidenced by orBec® NDA, in view
of Hager.7 (Id. at 18—19.)
2 Office Action dated July 2, 2014.
3 Dor BioPharm Press Release, News Center 9/12/2007, Internet Archive
capture downloaded from
http://web.archive.org/web/20071111171948*/http://www.dorbiopharma.co
m/news.htm, 9/30/2013 (“Dor BioPharm” or “Dor Press Release”).
4 orBec® NDA #22-062 Briefing Document, May 9, 2007, pp. 1—10,
accessed at http://www.fda.gov/ohrms/dockets/ac/07/briefmg/2007-4301 bl-
03-Dor.pdf on 9/30/2013 (“orBec® NDA”).
5 Stergiopoulos et al., US 2003/0055028 Al, published Mar. 20, 2003
(“Stergiopoulos”).
6 Jacob et al., US 2003/0060486 Al, published Mar. 27, 2003 (“Jacob”).
7 Hager et al., Effects of lithium carbonate on hematopoietic cells in patients
with persistent neutropenia following chemotherapy or radiotherapy, 36 J.
Trace Elem. Med. Biol. 91-97 (2002) (“Hager”).
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Application 12/633,631
6. Claims 10 and 17 stand rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Dor BioPharma, as evidenced by orBec® NDA, in view
of Kim.8 (Id. at 20-21.)
FINDINGS OF FACT
We adopt the Examiner’s findings as our own, including with respect
to the scope and content of the prior art and motivation to combine or
modify the cited references. The following findings are included for
emphasis and reference purposes.
FF 1. The Examiner finds that “the Specification lacks sufficient
direction to reasonably convey to one skilled in the relevant art that the
inventors, at the time the application was filed, had possession of the method
claimed, [wherein] the limitation reciting ‘within at least 24 hours’ is new
matter.” (Final Act. 4—5.)
FF 2. The Examiner finds that the Dor Press Release, as evidenced by
orBec® NDA, anticipates claims 1 and 10. (Final Act. 5—6; Ans. 8—11.)
The Dor Press Release indicates that oral BDP refers to oral beclomethasone
dipropionate, and that oral BDP is the active ingredient in the orBec® drug.
(Dor Press Release 1.)
FF 3. The Examiner finds that Stergiopoulos teaches methods of
treating inflammatory disorders of the gastrointestinal (GI) tract using
topical active corticosteroids that can be administered at a dosage of 0.1 mg
to 8 mg/day, that beclomethasone dipropionate (BDP) is the preferred
topically active corticosteroid, and that the dosage is a result effective
8 Kim et al., Mitogenic Influence of Human R-Spondinl on the Intestinal
Epithelium, 309 Science 1256-59 (2005) (“Kim”).
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variable that is capable of being optimized. (Final Act. 11, citing
Stergiopoulos claim 7 and 119.)
FF 4. Stergiopoulos teaches co-administration of anti-inflammatory
topical corticosteroids with non-steroidal anti-inflammatory drugs such as
COX-2 inhibitors (i.e., ibuprofen, ketoprofen, indomethacin, and naproxen).
(Stergiopoulos 118; see also Final Act. 11.)
FF 5. The Examiner finds that Jacob is directed to compositions and
methods for the treatment of ulcerative inflammatory and erosive disorders
of mucous membranes, including disorders related to adverse side effects in
radiation therapy, that growth factors such as keratinocyte growth factor
(KGF) may be used alone or in combination with another active agent, and
that BDP is a suitable steroidal anti-inflammatory agent. (Final Act. 15—16,
citing Jacob Abstract and H 3, 31, 52, and 54.)
FF 6. The Examiner finds that Hager teaches that lithium carbonate
can reduce the adverse effects of tumor-destructive treatment, and can be
used to treat patients following radiotherapy cost-effectively. (Final Act. 18,
citing Hager 96.)
FF 7. The Examiner finds that Kim is directed to the influence of R-
Spondinl on the regeneration and proliferation of intestinal epithelium, and
“was effective for preventing loss of epithelium proliferation and preserving
the architecture of both the small intestine and the colon [] in mice exposed
to damaging chemotherapy.” (Final Act. 20, citing Kim Abstract and 1258.)
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DISCUSSION
We adopt and agree with the Examiner’s findings, analysis, and
conclusions as set forth in the Final Action (Final Act. 3—21) and Answer
(Ans. 2—19). We discern no error in the Examiner’s rejections.
Rejection No. 1 — Written Description
Issue
Whether the Specification’s description shows that Appellants were in
possession of the method recited in claims 5 and 10.
Analysis
The Examiner finds that Appellants’ response filed March 10, 2014,
introduced new matter into the claims. (Final Act 3.) In particular, the
Examiner finds that amended claims 5 and 10 “recite a newly added wherein
clause requiring that the beclomethasone dipropionate be administered
‘within at least 24 hours’ after the exposure to radiation.” (Id.) The
Examiner also finds that “because the Specification describes administration
prior to irradiation and 2 hours following irradiation, the recitation of ‘within
at least 24 hours’ reads literally on embodiments outside the 0—2 hour
range,” and thus “would not reasonably direct the skilled artisan to [a] range
encompassed by ‘within at least 24 hours.’” (Id. at 4.)
Appellants argue that claim 5 includes administration of a second
compound (e.g., KGF), and that the Specification describes a clinical trial in
which KGF was administered three days before and three days after total
body irradiation. (Appeal Br. 13, citing Spec. 7,12.) Appellants also point
to Examples 3 and 4 of the Specification “which states the BDP and
BDP/KGF were administered starting after total body irradiation and until
GI recovery.” (Appeal Br. 13.) As for claim 10, Appellants argue that “one
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of skill in the art would know that symptoms of acute radiation . . . typically
occur with the first 24 hours following exposure.” {Id. at 14.)
We find that the Examiner has the better position. As an initial
matter, we agree with the Examiner that ‘“wherein administration occurs
within at least 24 hours following exposure to the radiation’, reads on
administration that occurs at any time within 24 hours and after 24 hours,
without any upper limit.” (Final Act. 6.) We also find that the case of In re
Wertheim, 541 F.2d 257 (CCPA 1976), is instructive with respect to the
terminology “at least.” In Wertheim, the court found that the claim
recitation of “at least 35%” solids content read on embodiments outside of
the described solid contents range of 25—60%. Id. at 263. Moreover, the
court found that, by pointing to this fact, the USPTO satisfied the initial
burden of establishing that “persons skilled in the art would not recognize in
the disclosure a description of the invention defined by the claims.” Id. at
263-64.
Appellants contend that, unlike the situation in Wertheim where the
court found that “Appellants have adduced no evidence to carry [this]
burden [as to] claim 1,” the recitation of “at least 24 hours” is reasonably
conveyed to one of skill in the art. (Reply Br. 6 (quoting Wertheim, 541
F.2d at 264).) To the contrary, we find that Appellants rely solely on
arguments, such as the argument that the Examiner is requiring literal
support in the Specification,9 and the argument as to what “one of skill in the
9 The Examiner’s statement that support “is found for the embodiment
wherein BDP was given 2 hours after total body irradiation . . . and prior to
irradiation” is not a requirement of literal support for the claim terminology
at issue. (Final Act. 3—4.)
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art would understand.” (Reply Br. 6—7.) However, those arguments cannot
take the place of evidence. See In re Pearson, 494 F.2d 1399, 1405 (CCPA
1974) (“Attorney’s argument in a brief cannot take the place of evidence.”).
Appellants also argue that “[t]he crucial understanding for the present
invention is that the lower limit for the start of administration of BDP
occur[s] within 24 hours of lethal radiation exposure.” (Reply Br. 7.)
However, the claims recite “within at least 24 hours,” not “within 24 hours,”
and the claim recitation reads on embodiments outside the written
description. (See Final Act. 3—5; Wertheim, 541 F.2d at 263—64.)
Conclusion
A preponderance of evidence of record fails to establish that
Appellants were in possession of the method recited in claims 5 and 10.
Accordingly, the rejection of claims 5 and 10 under 35U.S.C. § 112, first
paragraph, is affirmed. Claims 13 and 15—17 were not separately argued and
fall with claim 10.
Rejection No. 2 — Anticipation
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection under 35 U.S.C. § 102(b).
Analysis
Claim 1
Appellants contest the anticipation finding by arguing that the
Examiner has combined the Dor Press Release and the orBec® NDA to
achieve the anticipation rejection, and that Appellants “can point to several
elements of claim 1 which are not disclosed in either of the 102 references.”
(Appeal Br. 17.) In particular, Appellants argue that the Dor Press Release
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“fails to disclose release of BDP locally in the small bowel sufficient to
expose a metabolite thereof,” and that “there is no disclosure of BDP as the
sole drug administered for treatment of tissue damage due to epithelial
apoptosis.” {Id. at 16—17.)
We are not persuaded. Appellants are reminded that in considering
the disclosure of a reference for anticipation, “it is proper to take into
account not only specific teachings of the reference but also the inferences
which one skilled in the art would reasonably be expected to draw
therefrom.” In re Preda, 401 F.2d 825, 826 (CCPA 1968). Moreover,
“[ujnder the principles of inherency, if the prior art necessarily functions in
accordance with, or includes, the claimed limitations, it anticipates.”
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir.
1999).
The anticipation rejection is based on the Dor Press Release, as
evidenced by orBec® NDA.10 (Final Act. 5—6.) As explained by the
Examiner, the orBec® NDA evidences that the functional limitations of
claims 1 and 10 “necessarily flow from the administration of orBec®.”
(Ans. 9.) For example, the functional language regarding “release of BDP
locally in the small bowel sufficient to expose a metabolite thereof’ is
evidenced by the orBec® NDA’s description that BDP’s primary metabolite,
17-BMP, has systemic exposure and that one tablet referenced in the Dor
Press Release releases BDP in the mid-small intestine.* 11 (orBec® NDA 10.)
10 See MPEP § 2131.01 regarding use of extra references to show that a
characteristic not expressly disclosed in a § 102 reference is inherent.
11 We also acknowledge, but are unpersuaded by, Appellants’ argument that
the art does not inherently teach “that a dosage released solely in the small
bowel will treat acute radiation injury” (Reply Br. 9, emphasis added), at
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Contrary to Appellants’ contention regarding the disclosure of BDP as
the sole drug, the Dor Press Release discloses that “orBec® is formulated for
oral administration as a single product consisting of two tablets; one tablet is
intended to release BDP in the proximal portions of the GI tract and the
other tablet is intended to release BDP in the distal portions of the GI tract.”
(Dor Press Release 2.) The Dor Press Release also states that oral BDP may
be “given alone or in combination” for treatment of “destruction of epithelial
tissue” and “loss of epithelial cells.” (Dor Press Release 1.)
Claim 10
Appellants repeat the same arguments advanced in connection with
claim 1 and they are unpersuasive for the reasons set forth above.
Appellants also argue in the Reply Brief that the Dor Press Release is not
enabling. (Reply Br. 10-11.) However, because that argument was not
properly raised in the Appeal Brief, it is waived.12 See 37 C.F.R.
§§41.37(c)(l)(iv), 41.41(b)(2).
least because claim 1 is not so limited. See In re Self, 671 F.2d 1344, 1348
(CCPA 1982) (rejecting arguments “not based on limitations appearing in
the claims”).
12 Appellants merely state in the Appeal Brief that “it is not enough for the
reference(s) cited as anticipatory to be enabling of the claimed invention.”
(Appeal Br. 17.) This is not sufficiently specific to explain Appellants’
position, as required under Rule 41.37, especially given that Appellants bear
the burden to show non-enablement of a reference once the Examiner has
made a proper prima facie case of anticipation. See In re Antor Media
Corp., 689 F.3d 1282, 1288—89 (Fed. Cir. 2012). Further, the portion of the
Answer to which Appellants direct their Reply Brief argument appears in the
Final Rejection, and thus is not “responsive to an argument raised in the
examiner’s answer” as permitted under Rule 41.41. (See Final Act. 6,115.)
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Conclusion
A preponderance of evidence of record supports the Examiner’s
rejection of claims 1 and 10 under 35 U.S.C. § 102(b).
Rejection Nos. 3—6 — Obviousness
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejections under pre-AIA 35 U.S.C. § 103(a).
Analysis
Rejection No. 3 includes claim 1 and Rejection Nos. 3—6 include
claim 10. However, claims 1 and 10 are anticipated, and “anticipation is the
epitome of obviousness.” In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir.
2002) (citations omitted). Accordingly, the rejections of claims 1 and 10 for
obviousness are affirmed. The remaining claims subject to obviousness
rejections are addressed below.
Rejection No. 3
Dependent claims 4 and 13, and independent claim 5, recite that the
effective amount of the topically active corticosteroid is 8 mg/day.
(Corrected Claims App. 38—39.) Claim 5 also recites the administration of a
second compound, such as COX-2 inhibitors. (Id.)
Claim 4
Claim 4 is dependent on claim 1. (Id. at 38.) Appellants argue that
the Examiner has failed to present a prima facie case of obviousness based
on the combination of prior art, and that “[t]he mere fact that inflammation
is a symptom of each condition does not suggest to one of skill in the art that
the treatment would necessarily be effective for all conditions which include
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inflammation.” (Appeal Br. 22—23.) Appellants argue further that
Stergiopoulos is directed to the treatment of autoimmune conditions, and
that “[o]nly undue experimentation or impermissible hindsight would allow
one of ordinary skill to reach ... a conclusion” that a treatment regimen for
autoimmune conditions would effectively treat cell damage resulting from
lethal radiation exposure. (Id. at 23.)
We are not persuaded. Both the Dor Press Release and Stergiopoulos
teach the use of BDP to treat inflammation in the GI tract and, as explained
by the Examiner, it would have been obvious to provide BDP as taught by
the Dor Press Release at a dose (8 mg/day) as taught by Stergiopoulos for
treating inflammation in the gastrointestinal tract. (Final Act. 11; FF 3.)
Moreover, that Stergiopoulos may use BDP to treat inflammation in
connection with autoimmune conditions does not diminish its appropriate
combination with the Dor Press Release. See In re Beattie, 974 F.2d 1309,
1312 (Fed. Cir. 1992) (explaining that “the law does not require that the
references be combined for the reasons contemplated by the inventor”)
(citing cases); see also In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
We are likewise unpersuaded that providing the BDP of the Dor Press
Release at a dosage of 8 mg/day would require undue experimentation or
that the Examiner has engaged in impermissible hindsight. Appellants point
to no evidence that any of the Examiner’s findings were beyond the level of
ordinary skill at the time of the invention or could have been taken only
from Appellants’ Specification. See In re McLaughlin, 443 F.2d 1392, 1395
(CCPA 1971). Accordingly, for these reasons and the reasons set forth
above in connection with claim 1, we affirm the rejection of claim 4.
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Claim 13
Claim 13 is dependent on claim 10. (Corrected Claims App. 39.)
Appellants advance essentially the same arguments as advanced in
connection with claim 4, and those arguments are unpersuasive for the
reasons set forth above. In addition, Appellants argue an “unexpected result
is that BDP is effective at treating the symptoms of lethal radiation exposure
as the instantly claimed dosage.” (Appeal Br. 28.) We are unpersuaded
because that statement is merely attorney argument, unsupported by
evidence. Unexpected results must be established by factual evidence, and
“[m]ere argument or conclusory statements in the specification does not
suffice.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (quoting In re
De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)). Accordingly, for these
reasons and the reasons set forth above in connection with claim 10, we
affirm the rejection of claim 13.
Claim 5
Appellants advance essentially the same arguments as advanced in
connection with claim 4, and those arguments are unpersuasive for the
reasons set forth above. In addition, Appellants argue that “the Examiner’s
assertion that Stergiopoulos’ teaching of co-administration of BDP with non­
steroidal anti-inflammatory drugs renders claim 5 obvious is unsupported by
the prior art of record” and “requires the Examiner to use impermissible
hindsight.” (Appeal Br. 26.) We are not persuaded for the reasons set forth
above, and because Stergiopoulos expressly teaches co-administration of
BDP and a COX-2 inhibitor. (FF 3 and 4.)
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Rejection No. 4
Claim 15 is dependent on claim 10 and further recites the
administration of an effective dosage of KGF. (Corrected Claims App. 40.)
Appellants argue that
the combined teachings of the references would suggest to those
of ordinary skill in the art that they should explore through
experimentation a method for administering a treatment for acute
radiation exposure by administration of BDP in combination
with KGF and nothing more. Without experimentation, one of
skill in the art would have found the combined teachings lacking
for suggesting the method as recited in claim 10 or 15 because
one of skill in the art would understand that methods of treatment
are not necessarily transferrable between conditions.
(Appeal Br. 31.)
We understand Appellants’ argument to be that there would not have
been a reasonable expectation of success in combining the references
because some experimentation is required. However, the reasonable
expectation of success requirement “refers to the likelihood of success in
combining references to meet the limitations of the claimed invention.”
Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359,
1367 (Fed. Cir. 2016). Here, the combination is the administration of BDP
and another compound (KGF) that is known to be effective in treating
radiation patients. (FF 5.) Moreover, obviousness does not require absolute
predictability of success. See In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir.
1988) (“Obviousness does not require absolute predictability of success.
Indeed, for many inventions that seem quite obvious, there is no absolute
predictability of success until the invention is reduced to practice.”). In this
case, experimentation to verily the combination suggested by the prior art
does not obviate the obviousness of the combination. See Pfizer, Inc. v.
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Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) (“[A] rule of law
equating unpredictability to patentability, applied in this case, would mean
that any new salt. . . would be separately patentable, simply because the
formation and properties of each salt must be verified through testing.”).
Accordingly, for these reasons and the reasons set forth above in
connection with claim 10, we affirm the rejection of claim 15.
Rejection No. 5
Claim 16 is dependent on claim 10 and further recites the
administration of an effective dosage amount of lithium carbonate.
(Corrected Claims App. 40.) Here, the combination is the administration of
BDP and another compound (lithium carbonate) that is known to be
effective in treating radiation patients. (FF 6.) Appellants repeat the same
arguments advanced in connection with claim 15, substituting lithium
carbonate for KGF and claim 16 for claim 15. (Appeal Br. 33.) Those
arguments are equally unpersuasive for the reasons set forth above in
connection with claim 15. Accordingly, for these reasons and the reasons
set forth above in connection with claim 10, we affirm the rejection of claim
16.
Rejection No. 6
Claim 17 is dependent on claim 10 and further recites the
administration of R-spondin-1. (Corrected Claims App. 40.) Here, the
combination is the administration of BDP and another compound (R-
spondin-1) that is known to be effective for preventing loss of epithelium
proliferation and preserving the architecture of both the small intestine and
the colon. (FF 7.) Appellants repeat the same arguments advanced in
connection with claim 15, substituting R-spondin-1 for KGF and claim 17
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for claim 15. (Appeal Br. 35—36.) Those arguments are equally
unpersuasive for the reasons set forth above in connection with claim 15.
Accordingly, for these reasons and the reasons set forth above in connection
with claim 10, we affirm the rejection of claim 17.
Conclusion of Law
A preponderance of evidence of record supports the Examiner’s
rejections of claims 1, 4, 5, 10, 13, and 15—17 under 35 U.S.C. § 103(a)
(Rejection Nos. 3—6).
SUMMARY
We affirm the rejections of all claims on appeal.
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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