NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
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IN RE: MANUEL MARQUEZ, SAMANTHA M.
MARQUEZ,
Appellants
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2017-2038
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Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. 12/726,158.
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Decided: July 2, 2018
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MATTHEW JAMES DOWD, Dowd Scheffel PLLC, Wash-
ington, DC, argued for appellants. Also represented by
LOUIS VENTRE, JR., Law Firm of Louis Ventre, Jr., Oak-
ton, VA.
AMY J. NELSON, Office of the Solicitor, United States
Patent and Trademark Office, Alexandria, VA, argued for
appellee Andrei Iancu. Also represented by NATHAN K.
KELLEY, MARY L. KELLY, THOMAS W. KRAUSE.
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Before O’MALLEY, WALLACH, and HUGHES, Circuit Judges.
HUGHES, Circuit Judge.
2 IN RE: MARQUEZ
Manuel and Samantha Marquez appeal the decision
of the Patent Trial and Appeal Board affirming the rejec-
tion of U.S. Patent Application No. 12/726,158. The
Board did not err in concluding that the application fails
to enable claims 1–5, 7–8, 13, and 31–36. We therefore
affirm.
I
Manuel and Samantha Marquez (collectively,
Marquez) filed the ’158 application, entitled “An Artificial
Micro-Gland,” in March 2010. The application relates to
artificial glands and various methods of creating them.
The claimed artificial gland is an independent unit that
comprises a membrane shell surrounding a “bio-reactor”
that acts as a container or reservoir for products produced
by the membrane. J.A. 82. For most of the claims on
appeal, the membrane shell is composed of living cells.
See J.A. 146–56. The application describes dozens of cells
that can be used to form the outer membrane such as
stem cells, skin cells, white cells, neurons, and kidney
cells. In preferred embodiments, the bio-reactor enclosed
by the membrane is a gas, liquid, or gel capable of con-
taining whatever the membrane cells produce.
Claims 33 and 34 uniquely cover artificial glands with
membrane shells made up of cellular components rather
than cells. See J.A. 159–60. The application identifies a
wide range of cellular components that can be formed into
such membranes including enzymes, viruses, mitochon-
dria, and chlorophyll.
According to the specification, the claimed artificial
gland “holds the potential to play a vital role in tissue
engineering, stem cell engineering, synthetic biology, and
in the design of multicellular vehicles for food and phar-
maceutical applications.” J.A. 85. The invention alleged-
ly achieves these goals by providing a means to spatially
arrange cells and subcellular units “through the use of
external fields, microfluidic channels, and solvent-phase
IN RE: MARQUEZ 3
partitioning.”
Id. In addition, the invention allegedly
provides a new means for “manipulating controlled re-
leases or absorptions supporting biological activity.” J.A.
86.
In the Final Office Action, the examiner rejected all
pending claims of the ’158 application on a number of
grounds. The examiner rejected claims 1–4, 7, and 33–36
under 35 U.S.C. § 101 as being directed to patent-
ineligible subject matter; rejected claims 1–5, 7–8, and 13
under 35 U.S.C. § 112 for lack of written description;
rejected claims 1–5, 7–8, 13, and 31–36 under § 112 for
lack of enablement; and rejected claims 1–2, 4–5, 7, and
33–36 as anticipated under 35 U.S.C. § 102(b), or, in the
alternative, as obvious under 35 U.S.C. § 103(a). 1
Marquez appealed to the Board, which affirmed in
part and reversed in part the examiner’s rejections.
Ultimately, the Board affirmed the rejection of each claim
on at least one ground. The Board affirmed the rejection
of claims 1–4, 7, and 35 for claiming patent-ineligible
subject matter; affirmed the rejection of claims 1–5, 7–8,
and 13 for lack of written description; affirmed the rejec-
tion of claims 1–5, 7–8, 13, and 31–36 for lack of enable-
ment; and affirmed the rejection of claims 1–2, 4, 7, and
35 as anticipated or obvious. In affirming the examiner’s
rejection of all claims on appeal for lack of enablement,
the Board noted that Marquez waived its challenge to the
examiner’s enablement rejection of claims 1–5, 7–8, 13,
31–32, and 35–36.
1 The America Invents Act (AIA), Pub. L. No. 112-
29, effective September 16, 2012, amended §§ 102, 103,
and 112 for claims with effective filing dates falling on or
after March 13, 2013. Because Marquez’s application was
filed before March 13, 2013, we refer to the pre-AIA
versions of these provisions.
4 IN RE: MARQUEZ
Marquez appeals. We have jurisdiction under 28
U.S.C. § 1295(a)(4)(A).
II
We begin with the Board’s rejection of claims 1–5, 7–
8, 13, and 31–36 for lack of enablement. For a patent to
issue, the application must describe the invention and
“the manner and process of making and using it, in such
full, clear, concise, and exact terms as to enable any
person skilled in the art to which it pertains, or with
which it is most nearly connected, to make and use the”
claimed invention. 35 U.S.C. § 112, ¶ 1 (2012). A claim
lacks enablement if, at the effective filing date, a person
of ordinary skill in the art could not practice the invention
without “undue experimentation.” Wyeth & Cordis Corp.
v. Abbott Labs.,
720 F.3d 1380, 1384 (Fed. Cir. 2013).
Whether undue experimentation is required is “a conclu-
sion reached by weighing many factual considerations.”
ALZA Corp. v. Andrx Pharm., LLC,
603 F.3d 935, 940
(Fed. Cir. 2010) (quoting In re Wands,
858 F.2d 731, 737
(Fed. Cir. 1988)).
We review the Board’s ultimate enablement determi-
nation de novo and any underlying factual determinations
for substantial evidence. See Streck, Inc. v. Research &
Diagnostic Sys., Inc.,
665 F.3d 1269, 1288 (Fed. Cir.
2012).
A
The Board did not err in rejecting claims 33 and 34 for
lack of enablement. These claims recite artificial glands
with membranes made up of cellular components. The
Board determined that the ’158 application does not
provide guidance for how to form cellular components into
a membrane capable of surrounding a bio-reactor. The
application’s only working examples of artificial glands
use cells rather than cellular components. The Board
further determined that, as of the filing date, the prior art
IN RE: MARQUEZ 5
did not teach the creation of membranes from cellular
components. 2
Marquez argues that the specification discloses gen-
eral methods of creating artificial glands out of whole cells
that can be applied to creating membranes from cellular
components. These methods make use of “basic factors”
like “minimization of interfacial energy” and “electrostatic
interaction” to form cells or cellular components into
membranes. J.A. 31. The Board pointed out, however,
that, although these same basic factors may influence
whether cellular components adhere together to form a
membrane, whole cells and cellular components may be
affected differently by the manipulation of those forces.
The Board’s position is not, as Marquez claims, that
“positively-charged particles and negatively-charged
particles would sometimes be attracted to each other, and
sometimes not,” Appellant’s Reply Br. 25. Rather, the
Board observed that manipulating electrostatic forces to
form membranes out of cellular components as diverse as
enzymes, viruses, and chlorophyll likely requires adjust-
ing the known methods used to form membranes out of
whole cells. The Board further noted that neither the ’158
application nor the prior art teach what sort of adjust-
ments would be necessary.
The Board’s observations about differences between
the formation of cell-based membranes and the formation
of cellular component-based membranes are supported by
substantial evidence. On that basis, the Board did not err
2 On appeal, Marquez references a slideshow pur-
porting to depict the claimed artificial gland with a mem-
brane constructed from particles smaller than cells.
Appellant’s Reply Br. 28 (reproducing J.A. 216). This
slideshow post-dates the ’158 application’s filing date and
there is no indication that it was ever presented to the
Board. Accordingly, we do not consider this evidence.
6 IN RE: MARQUEZ
in concluding that creating the artificial glands covered by
claims 33 and 34 would require undue experimentation. 3
B
We also agree with the Board that Marquez waived
their challenge to the examiner’s rejection of claims 1–5,
7–8, 13, 31–32, and 35–36 for lack of enablement.
In appeals from the Board, “‘we have before us a com-
prehensive record that contains the arguments and evi-
dence presented by the parties’ and our review of the
Board’s decision is confined to the ‘four corners’ of that
record.” In re Watts,
354 F.3d 1362, 1367 (Fed. Cir. 2004)
(quoting In re Gartside,
203 F.3d 1305, 1314 (Fed. Cir.
2000)). While the court retains case-by-case discretion
over whether to apply waiver, we have routinely held that
a party waives an argument when its failure to present
the argument to the Board deprives the court of “the
benefit of the [Board’s] informed judgment.” In re NuVa-
sive, Inc.,
842 F.3d 1376, 1380 (Fed. Cir. 2016) (quoting
Watts, 354 F.3d at 1367–68).
Here, Marquez failed to present the Board with any
challenges to the examiner’s enablement rejection of
claims 1–5, 7–8, 13, 31–32, and 35–36. These claims all
relate to artificial glands with membranes composed of
whole cells. Unlike for claims 33 and 34, the examiner’s
rejection of these claims for lack of enablement was not
based on the application’s failure to enable the creation of
such artificial glands. Instead, the examiner determined
that the application did not enable any laboratory or in
3 Because we affirm the Board’s determination that
the ’158 application failed to enable the creation of the
artificial glands covered by claims 33 and 34, we do not
decide whether the Board erred in separately determining
that the application failed to enable any use of those
artificial glands.
IN RE: MARQUEZ 7
vitro uses of these artificial glands. While the application
mentions tissue engineering and controlled-release drug
delivery as potential uses, neither the application nor the
prior art disclose how the claimed gland could be used to
accomplish those feats. Accordingly, in the examiner’s
view, undue experimentation would be required to use the
claimed artificial glands.
In their appeal brief to the Board, Marquez did not
address this part of the examiner’s rejection. Marquez’s
brief devoted four pages to the examiner’s enablement
rejections in a section entitled “Claims 31 and 32 –
Ground for rejection: Lack of Enablement.” J.A. 730.
While the section header refers to claims 31 and 32, the
section’s analysis discusses the formation of artificial
gland membranes using cellular components, which
makes clear that the argument concerned the examiner’s
rejection of claims 33 and 34. 4 This section of Marquez’s
brief responds to the examiner’s argument that the ’158
application does not enable any uses of artificial glands
made of cellular components. But Marquez only argued
that the artificial glands made of cellular components
could be used in the same research activities as the artifi-
cial glands made of whole cells. They never responded to
the examiner’s argument that the application failed to
enable any uses of artificial glands made of whole cells.
Marquez now argues that they implicitly challenged
the examiner’s enablement rejections by (1) stating at the
start of their brief that “all rejections are in error”;
(2) challenging the examiner’s construction of the term
“gland” in the section of their brief discussing § 101
eligibility; and (3) citing, in the section of their brief
discussing anticipation and obviousness, an expert decla-
4 The Board noted this error in its final decision
and treated these arguments as directed to the rejections
of claims 33 and 34 as well.
8 IN RE: MARQUEZ
ration that asserts without explanation that the claimed
invention is useful. But a broad assertion of error and
arguments in response to other rejections did not indicate
to the Board that Marquez intended to challenge the
examiner’s enablement rejections of claims 1–5, 7–8, 13,
31–32, and 35–36. On these facts, we conclude that
Marquez waived any challenge to the rejection of these
claims for lack of enablement.
III
For the foregoing reasons, we affirm the Board’s
rejection of claims 1–5, 7–8, 13, and 31–36 for lack of
enablement. We have considered Marquez’s remaining
arguments but find them unpersuasive. Because we
affirm the Board’s rejection of every claim on appeal for
lack of enablement, we need not address Marquez’s chal-
lenges to the Board’s other grounds for rejection.
AFFIRMED
COSTS
No costs.
