N OTE : This disposition is nonprecedential. 

# United States **Court of Appeals**  **for the Federal Circuit**

______________________ IN RE: MANUEL MARQU EZ, 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

______________________

M ATTHEW J AMES D OWD , Dowd Scheffel PLLC , Was hington, DC, argued for appellants. Also represented by L OUIS V ENTRE , J R ., Law Firm of Louis Ventre, Jr., Oa kton, VA.

A MY J. N ELSON , Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, argued for appellee Andrei Iancu. Also represented by N ATHAN K. K ELLEY , M ARY L. K ELLY , T HOMAS W. K RAUSE

.

______________________
Before O’M ALLEY , W ALLACH , and H UGHES , Circuit Judges.

H UGHES , Circuit Judge

.IN RE : MARQUEZ 2

Manuel and Samantha Marquez appeal the decision of the Patent Trial and Appeal Board affirming the reje ction 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 Mar quez (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

comp rises a membrane shell surrounding a “bio

- reactor” that acts as a container or reservoir for products produced by the memb rane

. 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 co ntainin g whatever the membrane cells produce.

Claims 33 and 34 uniquely cover artificial glands with membrane shells made up of cell ular components rather than cells

. See J .A. 159

– 60

. The application identifies a wide range of cell ular components that can be formed into such membrane s including enzymes, viruses, mitocho ndria, 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 pha rmace utical applications. ” J.A. 85. The invention allege dly achieves these goals by providing a means to spatially arrange cells and subcellu lar units “ through the use of external fields, microfluidic channels, and solvent

- phaseIN RE : MARQUEZ 3

partitioning.” Id

. In addition, the invention allegedly provides a new means for “manipulating controlled r eleases or absorptions supporting biological activity. ” J.A. 86.

In the Final Office Action , the e xaminer rejected all pending claims of the ’158 application on a number of grounds. The e xaminer rejected claims 1– 4, 7, and 33

– 36 under 35 U.S.C. § 101 as being directed to patent

ineligible subject matter; rejected clai ms 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 § 1 12 for lack of enablement; and reject ed claims 1

– 2, 4

– 5, 7 , and 33

– 36 as anticipated under 35 U.S.C. § 102(b), or, in the alternati ve, 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. T he Board affirmed the rejection of claims 1

– 4, 7
, and 35 for claiming patent

- ineligibl e subject matter; affirmed the rejection of claims 1

– 5, 7

– 8, and 13 for lack of written description; affirmed the reje ction of claims 1– 5, 7

– 8, 13, and 31

– 36 for lack of enabl ement; and affirm ed 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 t hat Marquez waived its challenge to the examiner’s enablement rejection of claim s 1

– 5, 7

– 8, 13, 31

– 32, and 35

– 36.

1 The America Invents Act (AIA), Pub. L. No. 112

- 29, ef fective 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 M arch 13, 2013 , we refer to the pre

- AIA versions of these provisions

.IN RE : MARQUEZ 4

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 con nected, to make and use the” claime d 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 concl usion 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 determ ination de novo and any underlying factual determina tions for substantial evidence. See Streck, Inc. v. Research & Diagnostic Sys., Inc. , 665 F.3d 1269, 1288 (Fed. Cir. 2012)

. A

T he Board d id not err in rejecting claims 33 and 34 for lack of enablement. These claims recite artificial glands with membranes made up of cell ular components. The Board determined that the ’158 application does not provide guidance for how to form cellular compon ents into a membrane capable of surrounding a bio

- reactor. The application’s only working examples of artificial glands use cells rather than cell ular components. The Board further determined that, as of the filing date, the prior artIN RE : MARQUEZ 5

did not teach the c reation of membranes from cellular components. 2 Marquez argues that the specification discloses ge neral 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 ma y 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 parti cles 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

en zymes, viruses, and chlorophyll likely requires adjus ting 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 adjus tments 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 th at basis , the Board did not err

2 On appeal, Marquez references a slideshow pu rpor t ing to depict the claimed artificial gland with a me mbrane 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. A c cordingly, we do not consider this evidence.IN RE : MARQUEZ 6

in concluding that creating the artificial glands covered by claims 33 and 34 would require undue experimentation. 3

B
We also agree with t he 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 co mprehensive record that contains the arguments and ev idence presented by the parties ’ and our review of the Board’ s decision i s 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 deprive s the court of “the benefit of the [Board’s] informed judgment.” In re Nu Vasive, 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 examine r ’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 b ased on the application’s failure to enable the creation of such artificial glands. Instead, t he 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 gland s

. 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 experimenta tion would be required to use the claimed artificial gland s. 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 en titled “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 argu ment concerned the examiner ’s rejection of claims 33 and 34. 4 T his section of Marquez’s brief responds to the examiner ’s argument that the ’158 application does not enable any uses of artificial gl a nd s 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 artificia l glands made of whole cells.
Marquez now argues that they implicitly challenged the examiner’s enable ment rejections by (1) stat ing at the start of their brief th at “all rejections are in error ”; (2) chal lenging the examiner ’s construction of the ter m

“ gland ” in the section of their brief discussing § 101 eligibil ity; and (3) citing , in the section of their brief discussing anticipation and obviousness

, an expert decl a-

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.IN RE : MARQUEZ 8

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 rejec tions of claims 1

– 5, 7

– 8, 13, 31

– 32, and 35

– 36 . O n these facts, we conclude that Marque z waived any challenge to the rejec tion 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 cha llenges to the Board’ s other grounds for rejection.

AF FIRMED

C OSTS

No c osts.