Ex Parte Hollander et al

Patent Trial and Appeal Board

Mar 14, 2017

13599045 (P.T.A.B. Mar. 14, 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.
13/599,045 08/30/2012 Scott Wayne Hollander OTSU-001/00US
310697-2002
1058
58249 7590 03/16/2017
COOLEY LLP
ATTN: Patent Group
1299 Pennsylvania Avenue, NW
Suite 700
Washington, DC 20004
EXAMINER
PERREIRA, MELISSA JEAN
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
03/16/2017 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):
zpatdcdocketing@cooley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SCOTT WAYNE HOLLANDER, JOEL ROBERT
TIMBERLAKE, and MARJORY KADASH1
Appeal 2015-000345
Application 13/599,045
Technology Center 1600
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a bottle containing excipient free powdered contrast agent. The Examiner
rejects the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm the rejection for obviousness, but designate the affirmance
a new ground of rejection.
1 According to Appellants, the Real Party in Interest is Otsuka
Pharmaceutical Co., Ltd. App. Br. 3.
Appeal 2015-000345
Application 13/599,045
STATEMENT OF THE CASE
The Specification explains that “contrast agents, are [often] provided
to healthcare facilities in bulk containers that can hold a large quantity of the
medicament or contrast agent. . . . Typically, such concentrated materials
require the use of a separate container for dilution and/or consumption of the
medicament or contrast agent.” Spec. 2. The use of multiple containers for
preparing the “contrast agent for oral consumption can present various
undesirable results, such as, for example, improper dilution strength,
separation of the medicament or contrast agent from identifying labels
and/or separation of the medicament or contrast agent from instructions for
use.” Id.
Claims 1, 7, 8, 11—16, 20-24, and 31—43 are on appeal, and can be
found in the Claims Appendix of the Appeal Brief. Claim 1 is representative
of the claims on appeal, and reads as follows:
1. An apparatus, comprising:
a container body defining an opening in fluid
communication with an interior of the container body;
a cap coupled to the container body and enclosing the
opening;
a unit dose of an excipient free concentrated contrast
agent in powder form disposed within the interior of the
container body, the unit dose of the excipient free concentrated
contrast agent configured to be diluted to a select dilution
strength with a volume of a liquid receivable through the opening
and within the interior of the container body; and
a barrier member defining an interior, the container body
and the cap collectively disposed within the interior of the barrier
member, the barrier member being sealed.
App. Br. 17 (emphasis added).
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Application 13/599,045
Appellants request review of the Examiner’s rejection of claims 1, 7,
8, 11—16, 20-24, and 31—43 under 35 U.S.C. § 103(a) as unpatentable over
Kampfe2 in view of Zamparo,3 Conyers,4 Nagashima,5 Traboulsi,6 Wagner,7
Fennimore,8 and Mitsushima.9
As Appellants do not argue the claims separately, we focus our
analysis on claim 1 and claims 7, 8, 11—16, 20—24 and 31—43, stand or fall
with that claim. 37 C.F.R. § 41.37 (c)(l)(iv). See Appeal Br. 5—15, see
also 15 (“claim 32 is further allowable for similar reasons as discussed
above for claims 1 and 38”).
Findings of Fact
FF1. Zamparo teaches the production of “[ijnjectable radio-opaque
compositions for tissue augmentation and in particular hard tissue
augmentation, and kits.” Zamparo Abstract. Zamparo’skit
comprises: a) a first container comprising fibrinogen, b) a second
container comprising thrombin, and c) a third container comprising a
strontium salt. Id. ]Hf 21—24. “Optionally, the kit further comprises a
2 Kampfe et al., US 5,592,940, issued Jan, 14, 1997.
3 Zamparo et al, US 2010/0284919 Al, published Nov. 11, 2010.
4 Conyers et al., Antibody-Labeled Liposomes for CT Imaging of
Atherosclerotic Plaques: In Vitro Investigation of an Anti-ICAM Antibody-
Labeled Liposome Containing Iohexol for Molecular Imaging of
Atherosclerotic Plaques via Computed Tomography, 36 Texas Heart
Institute Journal, 393—403 (2009).
5 Nagashima et al., Embolization of arteriovenous malformation using
freeze-dried iohexol as contrast material, 5 J. Clinical Neuroscience 80—81
(1998).
6 Traboulsi et al., US 2011/0042255 Al, published Feb. 24, 2011.
7 Wagner et al., US 2013/0056386 Al, published Mar. 7, 2013.
8 Fennimore, US 4,150,744, issued Apr. 24, 1979.
9 Mitsushima, WO 2011/136336, published Nov. 2011.
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Application 13/599,045
fourth container comprising a dry, powdered iodinated contrast agent
or a iodinated contrast agent in solution.” Id. 126, 131.
FF2. Zamparo teaches numerous suitable iodinated contrast agents that can
be included in the kit as a dry powder. Id. H20, 82—86. Zamparo’s
kit contains fibrinogen and thrombin, which are mixed together first
and then the resulting solution is added to the other dry components,
including the dry contrast agent. See id. H 137—138.
FF3. Kampfe teaches a contrast agent mixing device that contains “two
containers 12 and 14 [that] are connected to a mixing chamber 20 by
feed pipes.” Kampfe 7:60—61. Kampfe teaches that “a predetermined
amount of concentrated contrast medium is mixed with a
predetermined amount of diluent, and optionally other additives, to
formulate the desired dosage form of contrast medium” for
consumption by the patient. Kampfe 3:64—67.
FF4. Kampfe’s device provides “a first vessel containing a concentrated
flowable contrast medium.” Kampfe 7:60—61. Kampfe teaches
numerous contrast media including “iohexol.” Kampfe 3:46. “These
concentrates are used in the form of solutions, dispersions or as free-
flowing powder and are put into appropriate concentrate containers.”
3:24—26 (emphasis added).
FF5. Traboulsi teaches a prefilled beverage bottle to which “a
predetermined amount of a water soluble oral contrast imaging agent
[is added] to the beverage within the chamber.” Traboulsi 121.
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Application 13/599,045
FF6. Traboulsi teaches a bottle with markings, shown in Fig. 1 below:
,je
Fig. 1 shows that “device 10 is a container in the form of a plastic
bottle defining a substantially cylindrical body 12,” with “[a] closure
in the form of a threaded cap 18 [that] is threadedly connected to the
neck 14 to seal the bottle.” Id. |32. The figure shows a side
elevational view “that includes a volume scale and a time scale on an
externally visible surface for identifying the amount of mixture that
should be consumed approximately on or before expiration of each
respective time interval.” Id. |29.
FF7. Traboulsi teaches that the bottle “may be provided with a dry
powdered version or concentrated liquid version of the beverage
requiring reconstitution with water or other liquid prior to or after the
addition of the oral contrast agent.” Id. |42.
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Application 13/599,045
FF8. Fennimore teaches the use of an envelope to package a bottle.
Figure 1, shown below, depicts such an envelope and bottle.
Fig. 1 reproduced above shows a “laminated foil envelope 1 [that] is
heat sealed along each edge at la and along the bottom at lb. An
additional top seal 1 c is provided and beneath this there is a tear notch
5 in one side of the envelope.” Fennimore 3:58—61. “The envelope is
preferably a metal foil/ polymer laminate, two layers of which can be
heat sealed.” Id. at 3:1—3. “The envelope in the combination resists
entry of oxygen and light and loss of water vapour.” Id. at 2:63—64.
FF9. The Specification explains that in one embodiment the “substance 140
can contain excipients such as dispersants, disintegrants, coatings,
enteric, fillers, flavors, glidants, sorbents, preservatives, sweeteners,
colors, wetting agents, binders, anti-caking agents, and/or any other
suitable substances to enhance dispersal, dilution, stability, taste,
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Application 13/599,045
processability, absorption, appearance, etc. of the concentrated
substance 140.” Spec. 120.
Principle of Law
“If a person of ordinary skill can implement a predictable variation [of
a known work], § 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007). “[W]hen a patent claims a structure already
known in the prior art that is altered by the mere substitution of one element
for another known in the field, the combination must do more than yield a
predictable result.” Id. at 416 (citing United States v. Adams, 383 U.S. 39,
50-51 (1966)).
Analysis
The Examiner’s position is that both Kampfe and Zamparo teach
using iodinated contrast agents in powder form. Ans. 3^4.
At the time of the invention it would have been obvious to one
ordinarily skilled in the art that a concentrated powder iodinated
contrast agent (e.g. iohexol) may be provided within a container
without any excipients as Kampfe et al. teaches that free-
flowing powder concentrates of iodinated contrast agent are put
into appropriate concentrate containers, without additives, prior
to mixing with a diluent, Zamparo et al. teaches of containers
containing a dry, powdered iodinated contrast agent (e.g.
iodixanol, etc.) prior to mixing with constituents from other
containers.
Ans. 4. We agree with the Examiner’s position that Kampfe teaches a vessel
containing powdered contrast agent, and Zamparo discloses a vessel
containing dry powdered contrast agent as part of a kit.
The Examiner relies on Traboulsi for teaching a container that meets
the physical limitations as claimed. See Ans. 5. The Examiner finds that
Traboulsi’s “container or device may be filled with a dry powdered version
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Application 13/599,045
or concentrated liquid version of the beverage requiring reconstitution with
water or other liquid prior to or after the addition of the oral contrast agent.”
Ans. 6. The Examiner finds that Traboulsi “teaches that the containers have
graduations” and concludes that “one ordinarily skilled in the art would
envision mixing a respective volume of diluent into the container comprising
iohexol in a concentrated powder form.” Ans. 7. Finally, the Examiner
relies on Wagner and Fennimore to teach enclosing a container with “a light­
tight gas-impermeable envelope to protect the iohexol composition against
gases, vapors and light.” Ans. 8.
We agree with the Examiner that the combination of references
support a prima facie case of obviousness. Zamparo teaches a kit for mixing
an injectable radio-opaque composition. FF1. The kit includes a unit dose
of dry powdered contrast agent by itself in a container. FF1 and FF2. The
fibrinogen and thrombin containing solution is added to the container
containing the dry contrast agent. FF2.
Kampfe teaches a mixing device that has a separate container that
stores multiple units of a concentrated form of dry contrast agent, which
remains in Kampfe’s container until a measured amount of the agent is
deposited into the mixing chamber. FF3 and FF4. Kampfe teaches mixing a
predetermined amount of contrast medium with a predetermined amount of
diluent to reach a desired dosage form. FF3. Kampfe teaches using the
contrast agent iohexol. FF4.
Traboulsi teaches a bottle for mixing a contrast agent. FF5.
Traboulsi’s bottle has a body and a cap, and includes graduations and a
window that show how much liquid is in the bottle. FF6. Traboulsi’s bottle
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can contain a powdered version of the beverage that requires reconstitution
of the powder before or after the addition of contrast agent. FF7.
Finally, Fennimore teaches a bag that can hold a bottle and protect the
contents of the bottle from “oxygen and light.” FF8.
We agree with the Examiner that it would have been obvious to
modify Traboulsi’s device by substituting the powdered beverage in the
bottle for a powdered contrast agent. See Final Act. 7 (“it would have been
obvious to one ordinarily skilled in the art to supply iohexol in a
concentrated powder form in the device of Traboulsi et al. as the combined
references above teach excipient free concentrated iohexol powder in a
container prior to mixing with a diluent (e.g. water)”). It is obvious to
substitute one known element for another when the combination yields a
predicable result. KSR, 550 U.S. at 416. In this case the predictable result is
to arrive at a powdered contrast agent stored in a bottle that allows the
powder to be reconstituted in the bottle. This predictable result is buttressed
by Zamparo’s teaching of storing dry contrast agent in a container as part of
a kit. Kampfe also teaches that the beverage and contrast agent components
are stored separately until ready to use. Kampfe teaches iohexol as a
contrast agent in the form of a flowable powder. Because Kampfe teaches
that iohexol can be mixed with a beverage for consumption by a patient, it
would be obvious to use this contrast agent with the bottle taught by
Traboulsi. Finally, we agree with the Examiner that placing the bottle
containing the contrast agent as suggested by the combination of Zamparo,
Kampfe, and Traboulsi into the bag as disclosed in Fennimore (as well as
Wagner) would be obvious for the purpose of protecting the contrast agent
from oxygen and light.
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Appellants contend that the
Examiner picks and chooses from eight different references in
an attempt to show the various recitations in claims 1,15 and
38 . . . [but still] fail[s] to show that these eight references
disclose or teach each and every limitation in claims 1,15 and
38, but Appellants submit that this is a clear case of hindsight
reconstruction.
Appeal Br. 6.
We are not persuaded by Appellants’ contention that picking and
choosing among various disclosures is improper in the context of an
obviousness analysis. See In reArkley, 455 F.2d 586, 587—588 (CCPA
1972). Furthermore, the argument that too many references are combined is
also unavailing as it has been recognized that reliance on a “large number of
references” does not, without more, weigh against the obviousness of the
claimed invention. In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991) (“The
criterion, however, is not the number of references, but what they would
have meant to a person of ordinary skill in the field of the invention.”).
We recognize that the Examiner also cites Conyers and Nagashima for
teaching that iohexol can be purchased in dry powder form or produced by
freeze-drying. With respect to claim 1, however, we find the teachings of
Conyers and Nagashima to be cumulative to the teachings of dry powdered
contrast agents shown in Kampfe and Zamparo and will not address these
references further. See generally In re Bush, 296 F.2d 491, 496 (CCPA
1961) (the Board may rely on less than all of the references relied upon by
Examiner).
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Excipient free powdered contrast agent
Appellants contend that none of the references “teach a unit dose of an
excipient free powder contrast agent disposed within a container.” Appeal
Br. 7, see also 13.
The Examiner’s position is that Kampfe discloses excipient free
contrast agent. See Ans. 11.
We begin with claim construction of the phrase “excipient free”
powder contrast agent, giving the claims their broadest reasonable
interpretation consistent with the Specification. In re Hyatt, 211 F.3d 1367,
1372 (Fed. Cir. 2000). According to the Specification, excipients include for
example dispersants, disintegrants, coatings, enteric, fillers, and flavors
among others. FF9. Given this definition of excipient it is understood that
an excipient is something that is added to the active agent in order to impart
a desirable feature to the active agent. Therefore, we interpret excipient free
to be a composition that does not contain any of the listed ingredients
identified as suitable for mixing with the active agent. FF9. The broadest
reasonable interpretation of “excipient free” powdered contrast agent as read
in light of the Specification is that nothing can be added to the contrast
agent, however, the contrast agent could still encompass any contaminates
that are part of the production, synthesis, and isolation of the contrast agent.
The Examiner finds that “the contrast agent that is free of excipients
and additives as dry powdered iodinated contrast agent is taught in the prior
art without additives, for example Kampfe et al. teaches that additives are
optional.” Ans. 11. We agree with the Examiner that Kampfe teaches
excipient free contrast agents, such as iohexol. Specifically, we find that the
contrast agents listed in Kampfe are not limited in any way. FF4; see
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Kampfe 3:45—53. In other words, Kampfe does not limit the iohexol,10 or
any other taught contrast media, to particular brands or compositions.
Because iohexol is available as an analytical agent there is no reason to
believe that the iohexol referenced in Kampfe includes excipients. Because
iohexol in Kampfe is not limited, it is reasonable to conclude that the
iohexol disclosed in Kampfe includes excipient free compositions of the
contrast agent. Accordingly, we are not persuaded by Appellants’
contention that excipient free iohexol is not taught by the cited art.
Contrast agent in a container
Appellants contend that “Traboulsi does not disclose or suggest that at
any point the bottle can contain only contrast agent.” Appeal Br. 10, see
also 12; Reply Br. 10. Appellants contend that the “language makes clear
that Traboulsi contemplates that the container could be provided with a
concentrated version of the beverage, not the contrast agent.” Appeal
Br. 12.
We are not persuaded. The Examiner explains that “[t]he device [of
Traboulsi] is a bottle, [having] a closure for a treaded [sic] cap connected to
the neck of the bottle to seal it. The device comprises graduations and labels
for providing conventional information, product ingredients, etc.” Ans. 13.
Traboulsi also discloses that powdered content can be stored in the bottle.
FF7. Zamparo teaches a kit for producing a contrast agent containing
composition that has components in a separate container. FF1. Zamparo
10 For example, iohexol is sold as an analytical standard that does not
contain any of the listed excipients,
http://www.sigmaaldrich.com/catalog/product/sial/74147?lang=en®ion=
US#, last visited March 2, 2017.
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teaches that the diluent is added to the container with the powdered contrast
agent. FF2. Although Zamparo’s exemplified containers are syringes, the
teaching of adding the diluent to the powder contrast agent is similarly
applicable to containers that are larger, such as the bottles taught in
Traboulsi.
Traboulsi teaches the production of a contrast beverage by adding the
contrast agent to the beverage in the bottle. See FF5—FF7. Traboulsi also
discloses that the beverage can be stored in the bottle as a dry powder that
can later be reconstituted. FF7. Both Kampfe and Zamparo teach that the
contrast agents can be in a dry powder form that is mixed with a diluent.
FF2 and FF3. Zamparo also teaches that the dry powder contrast agent is in
a separate container as part of the kit. FF1. Substituting the dry powdered
beverage with dry powdered contrast agent in Traboulsi’s bottle would have
been obvious in light of these disclosures about containment of dry powders
in various sized containers prior to the addition of diluent. The “substitution
of one element for another known in the field, the combination must do
more than yield a predictable result.” KSR, 550 U.S. at 416. In this case,
substituting a dose of dry powdered contrast agent in the bottle of Traboulsi
produces the predictable result that the powder can be mixed with a diluent
in the container as taught by Zamparo.
The question of obviousness cannot be approached on the basis that
an artisan having ordinary skill would have known only what was read in the
references, because such artisan must be presumed to know something about
the art apart from what the references disclose. See In re Jacoby, 309 F.2d
513, 516 (CCPA 1962). Moreover, the law presumes skill on the part of the
artisan rather than the converse. See In re Sovich, 769 F.2d 738, 742-43
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Application 13/599,045
(Fed. Cir. 1985). Based on the disclosure in the combination of references
(FF1—FF7), in conjunction with the knowledge of the ordinarily skilled
artisan we agree with the Examiner’s conclusion that
it would have been obvious to one ordinarily skilled in the art to
supply iohexol in a concentrated powder form in the device of
Traboulsi et al. as the combined references teach excipient free
concentrated iohexol powder in a container prior to mixing with
a diluent (e.g. water) from a second container and Traboulsi et
al. teaches that the container or device with graduations may be
used for mixing an oral imaging agent with a beverage and
diluent to generate an oral contrast agent solution wherein the
concentrated powdered contrast agent is contained within the
bottle prior to dilution. Therefore, one ordinarily skilled in the
art would envision mixing a respective volume of diluent into the
container comprising iohexol in a concentrated powder form.
Ans. 13.
Unit dose
Appellants contend that “[t]he Examiner fails to show that any of the
cited references disclose or suggest a ‘unit dose’ as recited in the claims.”
Reply Br. 8.
We are not persuaded. We understand that a “unit dose” is the
amount of contrast agent necessary for administration to a patient. As
explained above, Zamparo teaches a kit for the production of a contrast
agent containing composition that can be administered to a patient. FF1 and
FF2. Here, the components in Zamparo’s kit are stored in separate
containers and just before use they are then sequentially mixed in those
containers to produce the final mixed composition. Most importantly
Zamparo teaches adding the diluent to the dry powder components in the kit.
Because Zamparo’s containers are syringes and are taught to be coupled to
each other so the contents can be thoroughly mixed, it is reasonable to
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conclude that each of the components in each container represents a unit
dose of the respective components. Zamparo 122—131,1129 (“both
bipartite syringe bodies are attached to a two-way connecting device and the
contents are mixed by squeezing them through the injection needle attached
to the connecting device”). We find that Zamparo teaches a unit dose of
contrast agent stored in a container.
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 1, and Appellants have not
provided sufficient evidence of secondary considerations that outweighs the
evidence supporting the prima facie case. As Appellants do not argue the
claims separately, claims 7, 8, 11—16, 20-24, 31, and 33—43 fall with
claim 1.
Claim 32
Appellants contend that “none of the Cited References disclose or
suggest ‘the dilutable contrast agent [being] free of excipients and additives’
as recited in claim 32.” Appeal Br. 15.
As discussed above, the Examiner relies on Kampfe to disclose
excipient free contrast agent. We note that Kampfe does not limit the
iohexol, or other taught contrast media, to particular brands or compositions.
Therefore, it is reasonable to conclude that iohexol disclosed in Kampfe
includes excipient free compositions of the contrast agent, as these agents
are known to be available as analytical standards and are not limited to
particular commercially available compositions. Accordingly, we are not
persuaded by Appellants’ contention that excipient free iohexol is not taught
by the cited art.
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SUMMARY
We affirm the rejection of claims 1 and 32 under 35 U.S.C. § 103(a)
as unpatentable over Kampfe, Zamparo, Conyers, Nagashima, Traboulsi,
Wagner, Fennimore, and Mitsushima. Because claims 7, 8, 11—16, 20-24,
31, and 33—43 were not argued separately they fall with claim 1. Although
we affirm the Examiner’s rejection, we designate the affirmance a new
ground of rejection because our rationale differs slightly from that of the
Examiner.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37 CFR
§ 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12,
2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 CFR §
41.50(b) provides “[a] new ground of rejection pursuant to this paragraph
shall not be considered final for judicial review.”
37 CFR § 41.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the proceeding will be remanded
to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .
37 C.F.R. §41.500?)
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