NOTE: This disposition is nonprecedential.

United States Court of Appeals 

for the Federal Circuit ______________________ 

IN RE: MANUEL MARQUEZ, SAMANTHA M. 

MARQUEZ,

Appellants

______________________ 

2017-2038

______________________ 

Appeal from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in No. 12/726,158.

______________________ 

Decided: July 2, 2018

______________________ 

 MATTHEW JAMES DOWD, Dowd Scheffel PLLC, Washington, DC, argued for appellants. Also represented by 

LOUIS VENTRE, JR., Law Firm of Louis Ventre, Jr., Oakton, 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. 

______________________ 

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 rejection 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 containing 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, mitochondria, 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 pharmaceutical applications.” J.A. 85. The invention allegedly 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 releases 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 patentineligible 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 rejection of claims 1–5, 7–8, 13, and 31–36 for lack of enablement; 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 conclusion 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 determination 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 general 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 adjusting 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 adjustments 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 purporting to depict the claimed artificial gland with a membrane 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 comprehensive record that contains the arguments and evidence 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 NuVasive, 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 artificial 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 challenges to the Board’s other grounds for rejection. 

AFFIRMED

COSTS

No costs.