Ex Parte Ray et al

Patent Trial and Appeal Board

Feb 27, 2017

13328369 (P.T.A.B. Feb. 27, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/328,369 12/16/2011 Jay Richard Ray II 8138-23-1 (243125) 2324
30448 7590 03/01/2017
AKERMAN LLP
P.O. BOX 3188
WEST PALM BEACH, FL 33402-3188
EXAMINER
KIM, JENNIFER M
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
03/01/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
ip @ akerman.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAY RICHARD RAY II AND CHARLES D. HODGE1
Appeal 2016-001119
Application 13/328,369
Technology Center 1600
Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a
compounded transdermal pain cream for topical administration of multiple
medications, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
Claims 1—34 are on appeal. Claims 1, 8, and 15 are representative and
reads as follows:
1. A compounded transdermal pain management cream for the
topical administration of multiple medications
1 Appellants identify the Real Party in Interest as JCDS Holdings, LLC.
(Appeal Br. 2.)
Appeal 2016-001119
Application 13/328,369
simultaneously, the compounded transdermal pain
management cream comprising:
several medications provided within the transdermal
cream for topical administration to a patient, the several
medications comprising at least 20% of the total weight of
the transdermal cream, and including:
(1) at least one local anesthetic in an amount between
approximately 1.0% and approximately 7.0% of the
transdermal cream by weight;
(2) at least one nerve depressant in an amount between
approximately 5.0% and approximately 15.0% of the
transdermal cream by weight;
(3) at least one NS AID (Non-Steroidal Anti-
Inflammatory Drug) selected from the group consisting of
flurbiprofen and nabumetone in an amount between
approximately 5.0% and approximately 25.0% of the
transdermal cream by weight; and
(4) at least one muscle relaxant in an amount between
approximately 0.5% and approximately 4.0% of the
transdermal cream by weight such that multiple ailments are
addressed simultaneously.
8. A compounded transdermal pain management
cream for the topical administration of multiple medications
simultaneously, the compounded transdermal pain
management cream comprising:
water, alcohol, polyethylene glycol (PEG), glycerin,
lecithin, shea butter, coconut oil, ascorbyl palmitate, xanthan
gum, and disodium ethylenediaminetetraacetic acid
(EDTA);
several medications provided within the transdermal
cream for topical administration to a patient, the several
medications comprising at least 20% of the total weight of
the transdermal cream, and including:
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Application 13/328,369
(1) at least one local anesthetic in an amount between
approximately 1.0% and approximately 7.0% of the
transdermal cream by weight;
(2) at least one nerve depressant in an amount
between approximately 5.0% and approximately 15.0% of
the transdermal cream by weight;
(3) at least one NS AID (Non-Steroidal Anti-
Inflammatory Drug) selected from the group consisting of
flurbiprofen and nabumetone in an amount between
approximately 5.0% and approximately 25.0% of the
transdermal cream by weight; and
(4) at least one tricyclic antidepressant in an amount
between approximately 0.5% and approximately 4.0% of the
transdermal cream by weight such that multiple ailments are
addressed simultaneously.
15. A compounded transdermal pain management
cream for the topical administration of multiple medications
simultaneously, the compounded transdermal pain
management cream comprising:
several medications within the base composition for
topical administration to a patient, the several medications
include
at least one nerve depressant, at least one NS AID
(Non-Steroidal Antiinflammatory Drug);
at least one muscle relaxant;
at least one opioid or opiate agonist;
at least one local anesthetic; and
at least one NMDA (N-Methyl-D-aspartate) receptor
antagonist, and
at least one tricyclic antidepressant, wherein the
several medications comprise approximately 40% or more of
a final transdermal cream by weight.
(Appeal Br. A-l—A-5.)
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The following ground of rejection by the Examiner is before us on
review:
Claims 1—34 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Ozturk,2 Kolesnikov,3 ltaru,4 Weg,5 Collins,6 and
Callaghan.7
DISCUSSION
The Examiner finds that Ozturk teaches transdermal pain
compositions that include a number of different types of pain medications.
(Final Action 3.) According to the Examiner, one such composition is for
the treatment of neuropathic pain that is formulated as a cream and includes
in abase:
the tricyclic antidepressant, amitriptyline (2-4%),
the muscle relaxant, cyclobenzaprine (1—3%),
the nerve depressant, gabapentin (6—12%),
an anti-inflammatory, ibuprofen (15—22%), and
a local anesthetic, EMLA (5—10%).
(Id.) Another of the transdermal pain compositions the Examiner finds
Ozturk describes is:
Amitriptyline (2-4%),
Gabapentin (6—12%),
2 Ozturk et al., US 2004/0265364 Al, published Dec. 30, 2004.
3 Kolesnikov, EP 1964552 Bl, published Aug. 26, 2009.
4 ltaru, JP 7309749 A, published Nov. 28, 1995.
5 Weg, US 6,248,789 Bl, issued June 19, 2001.
6 Collins et al., US 8,535,738 B2, issued Sept. 17, 2013.
7 Callaghan et al., US 6,410,062 Bl, issued June 25, 2002.
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the NMDA receptor antagonist, ketamine (13—16%),
an anti-inflammatory, ketoprofen (2-4%), and
a local anesthetic, EMLA (5—10%).
(Id.) The Examiner finds that, while the specific anti-inflammatory
compounds that Ozturk identifies in the foregoing compositions are
ibuprofen and ketoprofen, it would have been obvious to one of ordinary
skill in the art to use flurbiprofen instead, in light of the teachings of
Kolesnikov and ftaru. (Final Action 4—5.) In particular, the Examiner finds
that Kolesnikov teaches analgesic compositions useful for neuropathy and
neuropathic inflammation formulated for topical use as a cream or a gel,
where the compositions include at least one NS AID and at least one opioid
analgesic. (Final Action 4.) The Examiner finds that Kolesnikov teaches
the interchangeability of NSAlDs, such as flurbiprofen, ibuprofen and
ketoprofen, all of which possess anti-inflammatory and analgesic properties.
(Final Action 5.) Moreover, the Examiner finds that ftaru teaches
flurbiprofen as an anti-inflammatory agent that is also effective in
painkilling for use in transdermal applications in an amount of from 5—10%.
(Final Action 4.)
Regarding claim 15, the Examiner finds that Ozturk does not teach the
inclusion of an opioid. (Final Action 4.) However, the Examiner finds that
adding an opioid to the Ozturk composition would have been obvious to one
of ordinary skill in the art in light of the teachings of Kolesnikov. (Final
Action 5.) In particular, the Examiner finds that Kolesnikov teaches that the
combination of NS AID and opioid results in synergistic potentiation of
analgesia. (Id.)
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Regarding claim 8, the Examiner finds that Ozturk does not teach the
recited excipients. (Final Action 4.) The Examiner finds, however, that it
would have been obvious to use the claimed excipients in light of Collins
and Callaghan. (Final Action 5.) In particular, the Examiner finds that
Collins teaches lecithin, EDTA, xanthan gum, alcohol, glycerin, water, Shea
butter, PEG, coconut oil and ascorbic acid derivative employed in a
composition to normalize skin or treat irritated or inflamed skin. (Id.) The
Examiner further finds that Callaghan teaches that ascorbyl palmitate is an
ascorbic acid derivative. (Id.) According to the Examiner, it would have
been obvious to include these ingredients as excipients in the modified
Ozturk composition because they are “well known ingredients] in
formulations for topical application to the skin.” (Final Action 6; Ans. 3—4.)
Regarding claim 22, the Examiner recognizes that claim 22 requires
ketamine in an amount of 30-40 % by weight and that Ozturk teaches
ketamine present in 13—16 % by weight of the composition. (Final Action
3,6.) The Examiner contends that it would have been obvious to arrive at a
composition with the claimed greater amount of ketamine in light of Weg,
which “teaches the transdermal dose of ketamine effective to alleviate pain
is approximately 0.01 to approximately 1 mg/kg of body weight (see claim
3).” (Final Action 5, 6; Ans. 6—7.) According to the Examiner, converting
the “amounts express [ed] in mg/kg of transdermal formulation to percentage
in a topical formulation” would have been obvious to one of ordinary skill in
the art and “discovering the workable percentage of effective therapeutic
amount in a topical cream of the ketamine involves only routine skill in the
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art,” and, thus, the claimed percentage “fail[s] to patentably distinguish over
the state of the art.” (Ans. 7.)
We agree with the Examiner’s factual findings and conclusion that the
various transdermal analgesic compositions recited in claims 1, 8, 12, and 15
would have been obvious to one of ordinary skill in the art in light of the
cited prior art. We disagree with the Examiner’s conclusion of obviousness
as to claim 22.
Substitution of flurbiprofen: claim 1 and claim 8
We do not find Appellants’ argument that Ozturk teaches away from
substituting a different NS AID into the analgesic compositions (Appeal Br.
17—18; Reply Br. 4—6) persuasive. According to Appellants, “the only
mention of ‘NSAIDs’ in the entire specification of Ozturk is the statement
thatNSAIDs ‘have local-anesthetic properties,’ and that ‘[l]ocal-anesthetic
compositions are inherently unstable’ and may ‘suffer from oxidative
instability.’” (Reply Br. 5.) According to Appellants, therefore, Ozturk
“warns against using NSAIDs (other than ‘ibuprofen’ and ‘ketoprofen’)
because [other NSAIDs] ‘are inherently unstable’ in the compositions.”
(Id.)
We do not understand there to be a warning by Ozturk against
substituting another NS AID for the ibuprofen or ketoprofen disclosed, or
any teaching in Ozturk that other NSAIDs “are inherently unstable” in the
Ozturk compositions. While Ozturk teaches that local-anesthetic emulsion
compositions are inherently unstable because phase separation can occur,
(Ozturk 16), Ozturk teaches compositions that apparently overcome this
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problem. In particular, the “preferred embodiment” of the invention
employs pentravan gel as the main base ingredient or it may be comprised of
80% by weight pleurinic gel and approximately 20% by weight lipoil, both
of which are emulsions. Thus, we do not understand Ozturk’s statement
regarding instability of “emulsion compositions” generally to be relevant to
the stability of Ozturk’s gel base with varying pain relieving ingredients.
Ozturk also teaches that lecithin compositions, which are routinely
used as bases for topical local-anesthetic compositions, are highly
oxidatively unstable, yet, Ozturk further discloses that it is known to use
lecithin compositions with NMDA-receptor antagonists and a tricyclic
antidepressant as well as ketamine “in pluronic lecithin organogel.” (Ozturk
1 6.) Moreover, as just discussed Ozturk teaches that, besides pentravan gel,
“[t]he base [that may be used for the transdermal compositions for the relief
of pain] may also be a base comprised of approximately 80% by weight
pleurinic gel and approximately 20% by weight lipoil.” (Ozturk 122.)
Lipoil is a lecithin containing composition.8 Thus, we find that Ozturk
discloses that lecithin does not render the gel base it exemplifies as unstable.
Moreover, Ozturk also teaches generally that the disclosed
transdermal compositions can include lecithin, as well as additives, such as
stabilizers. (Ozturk 121.) In light of the foregoing, we do not understand
Ozturk’s comment regarding the oxidative instability of lecithin
8 Lipoil includes “lecithin and isopropyl palmitate.” See, e.g., Lipoil®
product description at https://shop.fagron.us/en-
us/product/item_000550/lipoil.aspx.
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compositions generally to be a warning against including pain relieving
compounds in compositions that also include lecithin.
Furthermore, even if it could be said that Ozturk teaches that lecithin
formulations would have some amount of instability with pain relieving
ingredients other than those compounds specifically named in exemplary
compositions, we note that there is no stability limitation of independent
claim 1 or 8. An “obvious composition does not become patentable simply
because it has been described as somewhat inferior.” In re Gurley, 27 F.3d
551, 553 (Fed. Cir. 1994); see also In reMouttet, 686 F.3d 1322, 1334 (Fed.
Cir. 2012).
Appellants also argue that the Examiner’s rejection is in error because
the Examiner “does not provide any evidence” that flurbiprofen is taught as
an equivalent NS AID to ibuprofen or ketoprofen that “would provide the
same (or similar) required stability in the compositions of Ozturk.’ '’ (Appeal
Br. 18; Reply Br. 5.) We do not find this argument persuasive. First, as
noted above, neither of claims 1 or 8 has a stability limitation. Moreover,
we do not understand Ozturk to teach that there would be a stability problem
if other NSAIDs other than ibuprofen or ketoprofen were used in the
disclosed transdermal compositions. Appellants’ assertion that “Ozturk’'s
disclosure of only two NSAIDs (‘ibuprofen’ and ‘ketoprofen’) appears to be
based on Ozturk’s belief that these were the only two NSAIDs that could
provide a ‘stable, effective topical local-anesthetic composition with good
skin-penetration properties.’ Ozturk at Para. [0007],” is not a factual
teaching of Ozturk, but merely Appellants’ assumption. “Attorney’s
argument in a brief cannot take the place of evidence.” In re Pearson, 494
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F.2d 1399, 1405 (CCPA 1974). There is no reason this bare assertion must
be true. In other words, there is nothing in Ozturk limiting the anti­
inflammatory. To the contrary, Ozturk several times indicates more
generally that the compositions can include an anti-inflammatory generally.
(See, e.g., Ozturk H 11, 12.)
Furthermore, Kolesnikov lists ibuprofen, ketoprofen, flurbiprofen, and
other NSAIDs as capable of use in topical poloxamer gel formulations that
may contain other penetration enhancers and may or may not include
stabilizers. (Kolesnikov Tflf 24, 30—31.) A poloxamer is a copolymer of
polyoxyethylene and polyoxypropylene arranged in a particular tri-block
structure, and are known by several tradenames including Pluronics.9 One
of Ozturks’ disclosed gel bases appears to be such a copolymer, i.e.,
pleurinic gel. Kolesnikov’s teachings would reasonably suggest to one of
ordinary skill in the art that flurbiprofen would be interchangeable with the
specific NSAIDs taught by Ozturk.
For the foregoing reasons, Appellants do no persuade us that the
Examiner erred in rejecting claim 1 for obviousness over Ozturk,
Kolesnikov, Itaru, Weg, Collins, and Callaghan.
Claims 2—7, 25, 26, and 29-34 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
9 P. Alexandridis et al., “Poly(ethylene oxide)-poly(propylene oxide)-
poly(ethylene oxide) block copolymer surfactants in aqueous solutions and
at interfaces: thermodynamics, structure, dynamics, and modeling,” 96
Colloids Surf. A Physicochem. Eng. Asp. 1—46 (1995).
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Non-active ingredients required by Claim 8
Appellants contend that Ozturk teaches away from “modifying the
base (as proposed by the Office Action), as Ozturk expressly explains that
the base of Ozturk is ‘extremely important’ and that modifications to such a
base of Ozturk ‘would not be effective’.” (Reply Br. 2 (citing Ozturk 122.)
We disagree with Appellants that Ozturk teaches that the specific base noted
to be a preferred embodiment (or even the base noted as an alternative) is
identified by Ozturk as being “extremely important” or that modifications of
it “would not be effective.” Ozturk teaches that “[traditional cream or
ointment bases would not be effective” with respect to skin penetration, and
that having a proper base “that allows the various drug components to
penetrate the skin” is “extremely important.” (Ozturk 122.) This does not
lead to Appellants’ position that Ozturk teaches away from modifications of
the gel bases disclosed or the use of different base ingredients. As the
Examiner explained, Ozturk “do[es] not suggest that any pharmaceutically
acceptable carriers as a base including cream do not work in their
transdermal composition but rather that pentravan gel better suited their need
while the ‘traditional’ cream and ointment bases do not.” (Ans. 4.)
Ozturk teaches “[t]he base may be any pharmaceutically acceptable
carrier which is capable of transdermal delivery of the compounds contained
within the composition.” (Ozturk 121.) Contrary to Appellants position,
we do not find Ozturk to be referring, here, solely to the form of the carrier,
e.g., “‘cream’ versus ‘ointment’ versus ‘paste’ etc.” (Reply Br. 3.) Besides
noting the form of the medication, Ozturk identifies various ingredients that
the carrier may include. In particular, Ozturk states the carrier
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may include a variety of finite and non-fmite carriers including
... By way of example, . . . lipids, phospholipids, lecithins,
fatty oils, lanolin, vasoline, paraffins, glycols, higher fatty acids
and higher alcohols. . . There may also be additives including
binders, stabilizers, preservatives, flavorings, fiances, and
pigments.
(Ozturk 121.) Consequently, we find Ozturk indicates that the disclosed
specific base compositions can have additional ingredients, and even if the
specific identified base compositions are not used, so long as skin
penetration is achievable and the formulation is different from a so-called
“traditional cream or ointment base” such that it has better skin penetration,
such a base formulation is contemplated for use by Ozturk, (see Ozturk 1
22).
Collins teaches a composition that includes active ingredients, such as
a COX-2 Pathway inhibitor, in a base that includes the “base” ingredients
recited in claim 8, and that such a composition is to be topically applied for
normalizing skin or for treating irritated or inflamed skin. (Ans. 3.) As
Collins teaches the “COX Pathway” “ultimately contributes to inflammation
or pain in immune challenged tissue such as skin.” (Collins 3:4—10.) In
other words, “all of the ingredients listed in claim 8 are well known
ingredients] in formulations for topical application to skin” (Final Action 6)
that also include active ingredients that may be involved in inhibiting
inflammation or pain and one of ordinary skill in the art would have found
the selection of such ingredients to be obvious to use in the Ozturk
formulation to achieve the various benefits associated with them. For
example, Kolesnikov teaches that glycerin and polyethylene glycol are
known to be penetration enhancers for use with transdermal pain
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management compositions (Kolesnikov 124), and that natural gums have
beneficial use as suspending agents, and oils have beneficial use as
moisturizers (Kolesnikov H29—30). Kolesnikov also suggests the addition
of preservatives and antioxidants (Kolesnikov 131). Thus, we find that the
addition of ingredients, such as lecithin, EDTA, xanthan gum, alcohol,
glycerin, water, Shea butter, PEG, coconut oil and ascorbic acid derivative
as recited in claim 8, and which Collins indicates can be applied to the skin,
would be obvious to one of ordinary skill in the art, and that such a base
would have enhanced penetration.
For the foregoing reasons, Appellants do no persuade us that the
Examiner erred in rejecting claim 8 for obviousness over Ozturk,
Kolesnikov, Itaru, Weg, Collins, and Callaghan.
Claims 9—14, 27, and 28 have not been argued separately and
therefore fall with claim 8. 37 C.F.R. § 41.37(c)(l)(iv).
The inclusion of an opioid: claims 12 and 15
Appellants argue that, at most, “the Office Action merely provides an
argument that it would have been obvious to combine an opioid with a
NS AID,” not that “it would have been obvious to combine an opioid with
the entire composition of Ozturk.” (Final Action 19.) And Appellants argue
that “Kolesnikov appears to disclose that an opioid should not be used with a
tricyclic antidepressant (such as the tricyclic antidepressant of the
composition of Ozturk) because tricyclic antidepressants have ‘marked side
effects.’” (Id.) We do not find these arguments persuasive. “Obviousness
does not require absolute predictability of success. . . . For obviousness
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under § 103, all that is required is a reasonable expectation of success.” In
re O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988). As the Examiner
noted, Kolesnikov teaches that a synergistic potentiation of an
antinociceptive effect is achieved with the combination of an opioid and an
NSAID when applied topically. (Kolesnikov ^fl[ 27—28.) The prior art does
not suggest, nor do Appellants provide evidence that this synergy would be
erased or even diminished if these pain treatment medications were
combined with additional medications that achieved a local-anesthetic effect
when topically applied.
Regarding Appellants’ side effect argument, the fact that “Kolesnikov
never states that tricyclic antidepressants have marked side[] effects, ‘except
in a topical formulation’ or that the marked side effects ‘are systemic side
effects,’” (Reply Br. 7) is not conclusive as to whether one of ordinary skill
in the art would have understood the side effects discussion in Kolesnikov to
be associated with oral administration and not topical administration.
Contrary to Appellants’ argument (Reply Br. 7), we find it is a reasonable
position for the Examiner to have asserted that Kolesnikov’s discussion of
side effects of TCAs, like Ozturk, would have been understood by one of
ordinary skill in the art to mean side effects associated with oral intake of
medication. That is because, in discussing the analgesics used in the prior
art to treat neuropathic pain, including TCAs, opioids and NSAIDs,
Kolesnikov notes that “[conventionally, these drugs have been administered
orally in the form of solid preparations such as tablets and capsules.”
(Kolesnikov 12.) This is consistent with the disclosure in Ozturk that “[i]n
the past, patients were generally treated by administration of analgesics to
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relieve pain. A vast majority of such patients receive [d] doses of these
agents orally. Unfortunately, in some situations, oral administration of such
agents has been associated with a variety of side effects. . . .” (Ozturk 13.)
As Ozturk teaches, topical administration has the advantage of decreasing or
even precluding side effects that are associated with systemic administration
of drugs that have local-anesthetic properties. (Ozturk || 4—5.) In light of
the similarity of disclosure regarding oral intake of analgesics to relieve
pain, we agree with the Examiner that one of ordinary skill in the art would
have understood Kolesnikov’s reference to “marked side effects” with TCAs
to relate to oral administration as generally discussed in Ozturk, which
would be diminished or avoided with topical administration.
Consequently, Appellants do no persuade us that the Examiner erred
in rejecting claims 12 and 15 for obviousness over Ozturk, Kolesnikov,
Itaru, Weg, Collins, and Callaghan.
Claims 16—21, 23, and 24 have not been argued separately and
therefore fall with claim 15. 37 C.F.R. § 41.37(c)(l)(iv).
Ketamine present in an amount of30—40% of the transdermal cream by
weight: claim 22
Appellants contend that because Weg discloses the amount of
ketamine to be used based on body weight of a patient and not based on the
weight of the cream, Weg does not disclose the general conditions of the
claim such that one could conclude that it would be obvious to optimize the
dosage amount with the requisite percentage. (Reply Br. 8—9.) We agree
with Appellants. While Weg suggests ketamine can be used in transdermal
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formulations in varying amounts, and that it can be used as the sole active
ingredient or with other actives (Weg col. 9-10, and claim 3), there is
nothing in Weg to suggest in what percentage of the transdermal dosage
form ketamine would exist, and in particular, no reason to optimize the
amounts to the claimed range.
Consequently, we reverse the Examiner’s obviousness rejection of
claim 22 over Ozturk, Kolesnikov, Itaru, Weg, Collins, and Callaghan
SUMMARY
We affirm the rejection of claims 1—21 and 23—34 under 35 U.S.C. §
103(a) as being unpatentable over Ozturk, Kolesnikov, Itaru, Weg, Collins,
and Callaghan.
We reverse the rejection of claim 22 under 35 U.S.C. § 103(a) as
being unpatentable over Ozturk, Kolesnikov, Itaru, Weg, Collins, and
Callaghan.
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-IN-PART
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