Ex Parte Marquez et al

Patent Trial and Appeal Board

Mar 27, 2017

12880113 (P.T.A.B. Mar. 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.
12/880,113 09/12/2010 Manuel Marquez marquez!13 8511
24221 7590 03/29/2017
LOUIS VENTRE, JR
2483 OAKTON HILLS DRIVE
OAKTON, VA 22124-1530
EXAMINER
WILSON, MICHAEL C
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
03/29/2017 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):
lventre @ lventre. com
ventre, louis @ verizon. net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MANUEL MARQUEZ and
SAMANTHA M. MARQUEZ1
Appeal 2015-007406
Application 12/880,113
Technology Center 1600
Before JEFFREY N. FREDMAN, TAWEN CHANG, and RYAN H. FLAX,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of making an artificial micro-gland, which have been rejected as
non-enabled. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
The Specification describes an “artificial micro-gland hav[ing] a shell
or membrane of living cells surrounding a core or reservoir.” (Spec. 13.)
According to the Specification,
1 Appellants identify the Real Party in Interest as the inventors, Manuel
Marquez and Samantha Marquez. (Appeal Br. 3.)
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[a] method needs to be found to enable the fabrication of
artificial micro-glands with distinct regions of differing living
cells. This will add potentially diverse applications to healing
and organ growth where adjacent symbiotic cells can provide
favorable contributions to healing or cell growth. The
anisotropic micro-gland can provide a means to control the
application of chemicals, cells or biological units. This could
take the form of highly specific drug delivery system, specific
metabolite production by the shell, and/or preservation in the
reservoir, which is also referred to as the core, and selective
drug or cell delivery to a particular location within the body.
{Id. at 126.) Further according to the Specification, an anisotropic micro­
gland can be made by suspending a template between two adjoining liquids
in laminar flow in a microchannel, where “[different cells within the
template or within the fluid flows are . . . encouraged by taxis to form
membranes in distinct regions of the interfaces of the template with the
adjoining liquids.” {Id. at 127.)
Claims 1—17 are on appeal. Claim 1 is illustrative and reproduced
below:
1. A method of making an artificial micro-gland, the artificial micro­
gland comprising a continuous membrane of two or more types of
living cells, the continuous membrane defining an enclosed
volume, the enclosed volume comprising a reservoir serving as a
bioreactor, the method comprising the steps of:
forming a carrier fluid in a microchannel in a laminar flow, the
carrier fluid comprising:
a first fluid-flow;
a second fluid-flow adjoining the first fluid-flow at an
interface; and,
wherein, there is a distinct difference between the first
fluid-flow and the second fluid-flow, said distinct
difference causing the first fluid-flow to attract first
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Application 12/880,113
type living cells and causing the second fluid-flow to
attract second-type living cells;
introducing a droplet of fluid into the microchannel in a manner
such that the droplet of fluid straddles the interface between
the first fluid-flow and the second fluid flow, and, the
droplet of fluid comprising first-type living cells and
second-type living cells;
retaining the droplet of fluid in the carrier fluid until:
a first-partial membrane is formed by first-type living
cells on a portion of surface of the droplet of fluid in
contact with the first fluid-flow; and,
a second-partial membrane is formed by second-type
living cells on a portion of surface of the droplet of
fluid in contact with the second fluid-flow such that
the second-partial membrane joins with the first
partial membrane to form an artificial micro-gland in
the carrier fluid, the artificial micro-gland comprising
a continuous membrane surrounding the droplet of
fluid; and,
removing the artificial micro-gland from the carrier fluid.
(Appeal Br. 35—36 (Listing of Claims).)
The Examiner rejects claims 1—17 under 35 U.S.C. § 112(a) or
35 U.S.C. § 112 (pre-AlA), first paragraph, as failing to comply with the
enablement requirement. (Ans. 3.)
DISCUSSION
Issue
The Examiner finds that “[t]he specification lacks sufficient guidance
to make an artificial gland that exhibits a patentable use.” (Ans. 5.) In
particular, the Examiner finds that “it is clear the specification discloses the
methods claimed to be for the production of an anisotropic artificial gland [],
and the gland is to be used as an in vivo or in situ drug delivery system or as
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a treatment for tissue or organ repair.” (Id.) The Examiner further finds that
“[a] gland is an organ or a tissue that produces and secretes proteins,
enzymes or hormones in order to establish and maintain homeostasis,”
where “[t]he gland secretes the proteins either constitutively or regulated by
a signal from outside [of] the gland.” (Id. at 12.) Based on the above, the
Examiner finds that the claims are not enabled because “the structure
[recited in the claims] is not a gland in the meaning of the art” and “lacks an
enabled use as a drug delivery vehicle” or “for organ or tissue regeneration.”
(Id. at 14.)
More specifically, the Examiner finds that the Specification teaches
artificial glands with bacterial or yeast cells surrounding the core, which the
Examiner finds to lack patentable use in light of the disease-causing nature
of the bacterial and yeast cells. (Id. at 7—8.) The Examiner finds that the
Specification “does not offer any guidance for producing an artificial micro­
gland that reduces the effects of the host’s immune response so that the
micro-gland has an enabled use.” (Id. at 11; see also generally id. at 8—11.)
Likewise, the Examiner finds that “[i]t is not evident that the implanted
gland would receive sufficient oxygen and nutrient supplies so that [the
living cells composing the artificial micro-gland] would survive.” (Id. at
11—12.) The Examiner further finds that the structure made according to the
claimed methods are not enabled for use as an artificial gland or a
pharmaceutical delivery device, because the structure “lacks the mechanism
for either constitutive release or regulated release” of proteins, enzymes, or
hormones. (Id. at 13; see also generally id. at 12—14.) Finally, the Examiner
finds that the Specification does not enable an artificial gland where the
claimed “reservoir” is a gas, because the Specification “provides no
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guidance as to the type of gas that would solubilize proteins, enzymes or
hormones.” {Id. at 14.)
Appellants contend that the rejection is based on an unduly narrow
definition of the term “artificial micro-gland,” (Appeal Br. 31—33), and the
false premise that in vivo applications are the only use for the invention (id.
at 24—26, 30-31). Appellants further argue that, while certain embodiments
of the invention (e.g., those using pathogenic cells) may cause injury in vivo,
the invention also encompasses embodiments using, e.g., a person’s own
cells, which would not be pathogenic. (Id.) Finally, Appellants contend that
the Cheng Declaration2 and various news articles support the utility and
operability of the claimed invention. {Id. at 26—27.)
Appellants do not separately argue the claims, and we therefore limit
our analysis to claim 1. The issue with respect to this rejection is whether
the evidence of record supports the Examiner’s conclusion that claim 1 is
invalid for failing to comply with the enablement requirement.
Findings of Fact
1. The Specification states:
The artificial micro-gland has a shell or membrane of living
cells surrounding a core or reservoir. The term “living cells” is
intended to broadly encompass biological units and cells ....
The more significant applications of the invention are currently
expected to employ living cells comprising fungi, algae,
bacteria and mammalian cells like fibroblasts and stem cells.
The living cells may be one type or a multiple of types of cells.
2 Declaration of Zhengdong Cheng under 37 C.F.R. § 1.132 (Oct. 25, 2012)
(“Cheng Decl.”). The Cheng Declaration is not paginated. Therefore, all
reference to page numbers in the Cheng Declaration refer to page numbers
as if the Cheng Declaration was numbered consecutively beginning with the
first page.
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The reservoir is a micro-volume bio-reactor that supports a
biologically active environment. For example, it may host a
medicinal component or biological activity creating helpful
substances for promoting healing, vaccination, or food active
ingredients. The micro-gland has potential application as a
means for drug and/or cell delivery within human or other
animal.
(Spec. 113—4.)
2. The Specification states that the artificial micro-gland made by
the claimed method
add potentially diverse applications to healing and organ
growth where adjacent symbiotic cells can provide favorable
contributions to healing or cell growth. The anisotropic micro­
gland can provide a means to control the application of
chemicals, cells or biological units. This could take the form of
highly specific drug delivery system, specific metabolite
production by the shell, and/or preservation in the reservoir,
which is also referred to as the core, and selective drug or cell
delivery to a particular location within the body.
(Id. at 126; see also id. at 128.) The Specification states that the claimed
method “has direct implications on the development of molecular and
synthetic biology toolsets for redesigning or de novo engineering of
biological signaling networks.” (Id. at 129.)
3. The Specification states that “[t]he invention has application to
the biomedical and biotechnological industries.” (Id. at 1105.) The
Specification also states that “the artificial gland is useful for biological
tissue and organ repair and replacement and stem cell engineering and
biotechnology applications.” (Id. at 12.)
4. The Specification states that
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[t]he present invention takes the process of using [] laminar
flow within a microchannel a step further, using taxis, wherein
living cells direct their movements to the surface of a droplet,
bubble, gel, or combination thereof (herein called a template)
straddling the intersection of the two adjoining liquids in the
laminar flow. The term “fluid,” as used herein, can be a liquid
or a gas. However, most embodiments will use liquid laminar
flows and aqueous droplets of monodisperse living cell
suspensions in a solvent.
{Id. at 112; see also id. at H 44, 94, 103.) The Specification further states,
however, that the reservoir of the artificial micro-glands may contain “a
solid, liquid, gas or nothing at all.” {Id. at 125.)
5. Further according to the Specification,
[t]he method disclosed herein for making an artificial micro­
glands employs taxis to stimulate living cell self-assembly into
a continuous membrane, also referred to as a shell, surrounding
a template. Once surrounded, the template becomes the
reservoir of an artificial micro-gland.
Taxis is a form of tropism, which involves [] stimulating the
motility or migration of a cell or organism towards or away
from a location by a physical condition or distinct difference
between where the living cells are situated and an adjoining
location. This may be referred to herein as an agent, an agent
of taxis, or an agent of attraction.
{Id. at 11 6-7.)
6. The Specification states that “[o]ne or more agents influencing
the movement of the living cells to the boundary with the template may be
used.” {Id. at 113.) The Specification states that such agents may be
“another living cell that has a symbiotic relationship with the living cells”;
“pH; temperature; responsiveness to light; electrical charge; responsiveness
to a magnetic field; . . . responsiveness to an electric field; or ... a chemo-
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attractant...” (Id. at H 13—16; see also id. at H 51, 65, 70, 76, 79, 86, 89.)
The Specification further states that
[tjaxis may also take the form of. . . Gravitropism (or
geotropism), movement or growth in response to gravity;
Heliotropism, movement or growth in response to sunlight;
Phototropism, movement or growth in response to lights or
colors of light; Thermotropism, movement or growth in
response to temperature; Thigmotropism, movement or growth
in response to touch or contact; and, Host tropism or cell
tropism, the host range of pathogens.
(Id. at 116.) The Specification further states that examples of “agents
promoting taxis for a type of living cells” include “oxygen; carbon dioxide;
nitrogen oxide; sugar; phosphates, nitrates, sulphates, and potassium salts;
cyclic adenosine monophosphate (cAMP); inositon phospholipid (mPIP3);
actin; histamine; serotonin (5HT); plaletet [sic] acting factors (PAF);
arachidonic acid metabolites; diacykglyseril (IP3); leukotine B4; lipoxins;
prostaglandins; cytotaxin; f-met-leu-phe tripeptide; cytokines;
kinins,cytotaxins; anaphylatoxin peptide (C5a); aspartic acid (ASP); serine
(SER); and, a chemo-attractant.” (Id. at H 52, 65, 76, 86.)
7. The Specification states that the “living cells” used in its
invention are preferably either prokaryotic cells or eukaryotic cells. (Id. at
1153,64,75, 85,93.)
8. The Specification describes six embodiments of the invention,
but does not provide any working examples. (Id. at 119.)
Principles of Law
Section 112 requires that the patent specification enable those
skilled in the art to make and use the full scope of the claimed
invention without undue experimentation .... [S]ee also In re
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Goodman, 11 F.3d 1046, 1050 (Fed. Cir. 1993) (“[T]he
specification must teach those of skill in the art how to make
and how to use the invention as broadly as it is claimed.”)
Invitrogen Corp. v. Clontech Labs. Inc., 429 F.3d 1052, 1070—71 (Fed. Cir.
2005) (citation and internal quotation marks omitted).
Factors to be considered in determining whether a disclosure
would require undue experimentation . . . include (1) the
quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the
predictability or unpredictability of the art, and (8) the breadth
of the claims.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
“[T]he enablement requirement of § 112 incorporates the utility
requirement of § 101.” In re Fisher, 421 F.3d 1365, 1378 (Fed. Cir. 2005).
Courts “have required a claimed invention to have a specific and substantial
utility to satisfy § 101.” Id. at 1371.
[A]n application must show that an invention is useful to the
public as disclosed in its current form, not that it may prove
useful at some future date after further research. Simply put, to
satisfy the “substantial” utility requirement, an asserted use
must show that th[e] claimed invention has a significant and
presently available benefit to the public.
Id.
To satisfy
the ‘specific’ utility requirement, an application must disclose a
use which is not so vague as to be meaningless. . . . Thus, in
addition to providing a ‘substantial’ utility, an asserted use must
also show that th[e] claimed invention can be used to provide a
well-defined and particular benefit to the public.
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Id. “Nebulous” expressions such as “biological activity” or “biological
properties,” and “obscure” expressions such as “useful for technical and
pharmaceutical purposes” do not suffice to provide specific utility. Id.
“Enablement, or utility, is determined as of the application filing
date.” In re Brana, 51 F.3d 1560, 1567 n.19 (Fed. Cir. 1995). “It is an
applicant’s obligation to supply enabling disclosure without reliance on what
others may publish after he has filed an application on what is supposed to
be a completed invention. If he cannot supply enabling information, he is
not yet in a position to file.” In re Glass, 492 F.2d 1228, 1232 (CCPA
1974).
Analysis
We agree with the Examiner that the Specification has not enabled a
use for the method of claim 1. In particular, Appellants’ broad statements
regarding potential use of the artificial micro-gland made by the claimed
method (FF1—FF3) do not describe the “specific and substantial” utility
needed to satisfy the enablement requirement. Generic statements that the
artificial gland is useful for “drug and/or cell delivery within human or other
animal,” “healing and organ growth,” “development of molecular and
synthetic biology toolsets for redesigning or de novo engineering of
biological signaling networks,” or “biomedical and biotechnological
industries” are too vague to provide specific utility. In re Fisher, 421 F.3d at
1371. Similarly, these statements do not provide substantial utility because
they suggest that the artificial gland “may prove useful at some future date
after further research,” but do not show that it is “useful to the public as
disclosed in its current form.” Id. The Specification states, for example, that
“[t]he micro-gland has potential application as a means for drug and/or cell
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delivery within human or other animal” (FF1 (emphasis added)), and add
“potentially diverse applications to healing and organ growth where adjacent
symbiotic cells can provide favorable contributions to healing or cell
growth” (FF2 (emphasis added).)
In this respect, we also note that, while working examples are not
necessary to satisfy enablement, they are desirable in complex technologies,
and the Specification provides no such examples of using the artificial gland
manufactured by the claimed method. In re Strahilevitz, 668 F.2d 1229,
1232 (CCPA 1982) (working examples desirable, but not necessary); In re
Fisher, 421 F.3d at 1377 (finding lack of specific and substantial utility
because “[applicant’s] laundry list of uses, like the terms ‘biological activity’
or ‘biological properties’ alleged in Kirk, are nebulous, especially in the
absence of any data demonstrating that the claimed [inventions] were
actually put to the alleged uses”).
Appellants contend that the rejection is based on an unduly narrow
definition of the term “artificial micro-gland,” (Appeal Br. 31—33; Reply Br.
30-34), and the false premise that in vivo applications, such as in vivo or in
situ drug delivery, are the only use for the invention (Appeal Br. 24—26, 30-
31; Reply Br. 34—37). Appellants contend that, in part as a result, the
Examiner’s arguments arbitrarily required enablement of limitations not in
the claims, such as protecting the living cells making up the artificial gland,
providing a predictable rate of release of materials from the artificial gland,
and/or reducing the effects of the host’s immune response. (Reply Br. 29—
30, 33.) Appellants contend that the claimed invention can have other uses,
“such as for research activities or in vitro applications.” (Appeal Br. 25, 27—
30; Reply Br. 34-37.)
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We are not persuaded. Assuming Appellants’ construction of
“artificial micro-gland” to be correct, the Specification nevertheless has not
disclosed a specific and substantial utility for such a structure. In particular,
while we agree that an enabled use of the recited artificial gland need not be
an in vivo use, generic statements that the claimed invention is useful for
“research activities or in vitro applications” such as “stem cell engineering
and biotechnology applications” or “applications to healing and organ
growth” do not disclose a specific and substantial use necessary for
enablement: Generalized description of the invention’s potential uses is too
vague to constitute specific use, and the lack of information regarding how
the artificial gland may be used in research activities or the enumerated in
vitro applications indicates that the Specification has at most suggested that
the artificial micro-gland “may prove useful at some future date after further
research,” which does not suffice to show substantial use. In re Fisher, 421
F.3d at 1371.3
3 Appellants also argue that U.S. Patent Application No. 12/726,158 (“’158
Application”), which is parent to the instant application, provides additional
information regarding uses of the artificial gland made by the claimed
methods, such as “improv[ing] the potential for in vitro organ growth by
eliminating the need for scaffolds” and “application to three-dimensional (3-
D) in vitro cell cultures, in which cells are grown in environments that more
closely mimic native tissue architecture and function.” (Appeal Br. 28—29.)
We find the disclosure of the ’158 Application similarly lacking, however,
because it at best suggests that the artificial gland of the invention “may
prove useful at some future date after further research” rather than showing
that it has a significant and presently available benefit to the public. In re
Fisher, 421 F.3d at 1371. The ’158 Application states, for instance, that
“[t]he computer-aided inkjet printing of viable independent micro-glands
units holds potential for creating living tissue analogs, and may eventually
lead to the construction of engineered human organs.” (’158 Application
1169 (emphasis added).) Like the instant Specification, the ’158
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Appellants further argue that, while certain embodiments of the
invention (e.g., those using pathogenic cells) may cause injury in vivo, the
invention also encompasses embodiments using, e.g., a person’s own cells,
which would not be pathogenic. (Appeal Br. 25; see also Reply Br. 26—27,
28,37.) We are not persuaded. As an initial matter, even for embodiments
that are not pathogenic, the Specification has not enabled a specific and
substantial use in vivo for the reasons discussed above. Furthermore,
enablement must be commensurate with the full scope of the claim, and
claim 1 encompasses a wide variety of cells, including prokaryotic cells.* * * 4
(FF7.)
Finally, Appellants contend that the Cheng Declaration and various
news articles support the utility and operability of the claimed invention.
(Appeal Br. 26—27.) With respect to the Cheng Declaration, we note first
that expert opinions on ultimate legal issues, such as statements in the Cheng
Declaration that “the methods of making the artificial gland [is] fully
descriptive and readily followed without the necessity for experimentation,”
that “peer[] reviewed scientific reports on the manufacture and use of the
Application provides no working example of using the artificial gland. In
addition, these uses in vivo were identified by the Examiner as non-enabled
(see, e.g., Ans. 7).
4 In the Reply Brief, Appellants also argue that an artificial gland comprising
pathogens may nevertheless be useful because “a scientist might want to
study pathogens involved, or perhaps investigate a delivery mechanism to
cause disease to control pests.” (Reply Br. 26.) Appellants further argue
that they “state[] up front in the application that the technology has uses in
‘biotechnology applications.’” (Id. at 26—27 (citation omitted).) As
discussed above, however, such nebulous discussion of potential use does
not satisfy the requirement of specific and substantial use. In re Fisher, 421
F.3d 1371.
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artificial gland [support] the operability, functionality and usefulness of the
claimed artificial gland,” and that “the claimed artificial gland [is] a unique
innovation that is described in sufficient detail to be operable and to enable it
to be made and used without undue experimentation” (Cheng Decl. 2, 4), are
not entitled to weight absent supporting evidence. In re Reuter, 670 F.2d
1015, 1023 (CCPA 1981). Indeed, it is unclear whether the statements in the
Cheng Declaration refer to the instant patent application at all, as Dr. Cheng
refers to paragraph 277 of the patent application, which does not exist in the
instant Specification. (Cheng Decl. 2.) Finally, all but one of the references
cited by Dr. Cheng as supporting the “operability, functionality and
usefulness of the claimed artificial gland” are dated after the date of the
patent application, and there is no evidence that they represent the state of
the art at the time the patent application was filed.5 (Cheng Decl. 3.)
Appellants also cite to news articles6 they contend show “[o]ne of the
inventors of the artificial micro-gland [] receiving] acclaim in the field for
5 The only cited reference that predates the date of the application, Aug. 21,
2010, is a presentation at NANOSPAIN 2010. Manuel Marquez et al., A
New Paradigm for Cell Architecture: Celloidosomes®, NANOSPAIN 2010
(March 23, 2010) (“NANOSPAIN Presentation”), available at
http://www.nanospainconf.org/2010/Posters/Nano Spain2010_Marquez.pdf.
If anything, the presentation supports the conclusion that the claimed
artificial gland does not have a specific and substantial use at the time of the
application, as it “focus[es] on showing the potential of [the] emerging and
enabling technology.” {Id. (emphasis added).)
6 Jacquellena Carrero, INNOVATOR: Samantha Marquez, pioneering teen
scientist (2013), available at http://nbclatino.com/2013/10/08/innovators-
samantha-marquez/ (last visited Mar. 6, 2017); CNN, Repairing organs with
clusters of cells (2014), available at
http://edition.cnn.com/videos/intemational/2014/07/17/spc-vital-signs-
medical-discoveries-b.cnn (last visited Mar. 6, 2017).
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her invention.” (Appeal Br. 27.) These news articles allege a broad range of
potential uses for “celloidosomes,” which Appellants contend to be the
artificial micro-gland recited in the claims. None of them, however,
suggests that the Specification enables such uses because none of them
suggests that the celloidosome is useful for such applications in its current
form, without further research.
In their Reply Brief, Appellants argue for the first time that twelve
publications cited in their Information Disclosure Statement “delve into the
testing of, and explain the importance, usefulness and applications for, the
invention and similar products.” (Reply Br. 24—25.) One of the only two
publications Appellants specifically mention, however, is the NANOSPAIN
Presentation already discussed in the context of our discussion of the Cheng
Declaration. Appellants also argue that Rastogi,7 which “discusses prior art
fabrication of similar special particles using other techniques,” shows that
the artificial gland of the claims is useful because it further lists “many
[other] references discussing fabrication of similar particles.” {Id. at 27.)
Appellants’ argument is not persuasive: Appellants do not point to any
particular use of Rastogi’s particles that is also enabled for the claimed
artificial gland. Likewise, given the lack of any analysis by Appellants as to
the remaining publications, we are not persuaded by Appellants’ attorney
argument that the publications provide adequate guidance regarding the use
of the artificial gland recited in the claim. {Id. at 25—26.)
7 Vinayak Rastogi et al., Communication, Anisotropic Particle Synthesis
Inside Droplet Templates on Superhydrophobic Surfaces, 31
Macromolecular Rapid Communications 190 (2010).
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Accordingly, we affirm the Examiner’s rejection of claim 1 under
35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing
to comply with the enablement requirement. Claims 2—17, which are not
separately argued, fall with claim 1.
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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