Ex Parte Marquez et al

Patent Trial and Appeal Board

Mar 13, 2017

12726158 (P.T.A.B. Mar. 13, 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.
12/726,158 03/17/2010 Manuel Marquez marquez!58 1680
24221 7590 03/15/2017
LOUIS VENTRE, JR
2483 OAKTON HILLS DRIVE
OAKTON, VA 22124-1530
EXAMINER
WILSON, MICHAEL C
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
03/15/2017 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,
SAMANTHA M. MARQUEZ, and ANTONIO GARCIA1
Appeal 2015-007398
Application 12/726,158
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 an
artificial gland, which have been rejected as directed to non-statutory subject
matter, lacking in written description, non-enabled, and anticipated or
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as the inventors Manuel
Marquez and Samantha Marquez. (Appeal Br. 3.)
1
Appeal 2015-007398
Application 12/726,158
STATEMENT OF THE CASE
“Tissue and organ engineering are popular terms used to describe
efforts to form complex living structures using cells as building blocks.”
(Spec. 13.) According to the Specification, “[m]ore sophisticated tissue
structures are presently possible using scaffolding, which requires the use of
a macro-scale material that can promote 3-dimensional cell organization into
tissue by providing a surface for cell attachment and proliferation.” (Id. at
16.) Further according to the Specification, the present invention provides a
“micrometer-to-millimeter-scale artificial gland comprising a membrane of
cellular material surrounding a reservoir comprising a bioreactor,” which is
“capable of being used to support the growth of organs and other biological
material without the use of macro-scale scaffolds” and “can control the 3-
dimensional arrangements of cells and subcellular systems in ... a way that
can mimic nature.” (Id. at 118.)
Claims 1—5, 7, 8, 13, and 31—36 are on appeal. Claim 1 is illustrative
and reproduced below:
1. An artificial gland comprising an independent unit for
promoting biological activity, the independent unit consisting
of an isolated product, the artificial gland further comprising:
cells assembled in three dimensions in a component selected
from the group consisting of a flow chamber, a
micro fluidic device, and an ink jet printer, the cells
organized to form a membrane, the membrane configured
to define an enclosed volume; and,
a reservoir within the enclosed volume, the reservoir
comprising a bio-reactor containing a product of activity
of the cells.
(Appeal Br. 77 (Claims App’x).)
2
Appeal 2015-007398
Application 12/726,158
The Examiner rejects claims 1—4, 7, and 33—36 under 35 U.S.C. § 101
as being directed to non-patentable subject matter.2 (Ans. 3.)
The Examiner rejects claims 1—5, 7, 8, and 13 under 35 U.S.C.
§ 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply
with the written description requirement.3 {Id. at 5.)
2 There is some confusion as to which claims are subject to the rejection
under 35 U.S.C. § 101. In the June 3, 2014 Office Action, the Examiner
stated that “[cjlaims 1—7 and 31—36 are rejected under 35 U.S.C. [§] 101
because ... the cells of claims 1, 2, 4, 7 and 31—36 do not indicate the ‘hand
of man.’” (June 3, 2014 Office Action 2 (emphasis added).) In the Final
Rejection, the Examiner states that “[cjlaims 1—4, 7, and 34—36 are rejected
under 35 U.S.C. [§] 101 because ... the cells of claims 1, 2, 4, 7 and 31—36
do not indicate the ‘hand of man’ for reasons set forth in the office action
mailed June 3, 2014.” (Final Act. 2 (emphasis added).) In the Appeal Brief,
Appellants stated that all of the claims, i.e., claims 1—5, 7, 8,13, and 31—36,
are rejected under 35 U.S.C. § 101 (Appeal Br. 29). In the Answer, the
Examiner did not appear to have included any new ground of rejection or
withdrawn the rejection of any claim under 35 U.S.C. § 101, but now states
that “[cjlaims 1^1, 7 and 33—36 remain rejected under 35 U.S.C. [§] 101.”
(Ans. 3 (emphasis added).) Finally, in the Response to Arguments section of
the Answer, the Examiner states both that “[cjlaims 1—4, 7 and 33—36
remain rejected under 35 U.S.C. [§] 101” and that “claims 31 and 33 are not
rejected under 35 U.S.C. [§] 101.” {Id. at 15 (emphasis added); see also id.
at 20 (analyzing claims 33 and 34 under 35 U.S.C. § 101).) Taking all of the
above into account, particularly the Examiner’s explicit statement that claim
31 is not rejected under 35 U.S.C. § 101, the analysis of claims 33 and 34
under 35 U.S.C. § 101 in the Answer, and the corresponding lack of analysis
of claims 31 and 32, we understand for purposes of this decision that the
Examiner’s 35 U.S.C. § 101 rejection applies to claims 1—4, 7, and 33—36.
3 Our analysis does not change regardless of whether the Examiner’s written
description and enablement rejections are based upon 35 U.S.C. § 112(a) or
35 U.S.C. § 112 (pre-AIA), first paragraph.
3
Appeal 2015-007398
Application 12/726,158
The Examiner rejects claims 1—5, 7, 8, 13, and 31—36 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. (Id. at 7.)
The Examiner rejects claims 1, 2, 4, 7, 33, and 34 under pre-AIA
35 U.S.C. § 102(b) as anticipated by or, in the alternative, under pre-AIA
35 U.S.C. § 103(a) as obvious over, Zetter.4 (Id. at 13.)
The Examiner rejects claims 1, 2, 4, 7, 33, and 34 under pre-AIA
35 U.S.C. § 102(b) as anticipated by or, in the alternative, under pre-AIA
35 U.S.C. § 103(a) as obvious over, Debnath.5 (Id. at 14.)
The Examiner rejects claims 1, 2, 4, 7, and 33—36 under pre-AIA
35 U.S.C. § 102(b) as anticipated by or, in the alternative, under pre-AIA
35 U.S.C. § 103(a) as obvious over, Kirk,6 as evidenced by Volvox Study
Guide.7 (Id.)
4 Bruce R. Zetter et al., Expression of a high molecular weight cell surface
glycoprotein (LETSprotein) by preimplantation mouse embryos and
teratocarcinoma stem cells, 75 Proceedings Nat’l. Acad. Sci. 2324
(1978).
5 Jayanta Debnath et al., Morphogenesis and oncogenesis ofMCF-lOA
mammary epithelial acini grown in three-dimensional basement membrane
cultures, 30 Methods 256 (2003).
6 David L. Kirk, Quick Guide, Volvox, 14 Current Biology R599 (2004).
7 We were unable to locate citation information for the Volvox Study Guide
in either the Answer or the Final Rejection. Nevertheless, the Volvox Study
Guide is cited only as evidence of the size of the volvox spheroid, which we
understand is relevant only to the limitation in claim 3 that “the artificial
gland has a dimension not exceeding 500 microns.” As Appellants did not
separately argue claim 3, the Volvox Study Guide is not necessary to our
decision.
4
Appeal 2015-007398
Application 12/726,158
The Examiner rejects claims 1, 2, 4, 5, and 33—36 under pre-AIA
35 U.S.C. § 102(b) as anticipated by or, in the alternative, under pre-AIA
35 U.S.C. § 103(a) as obvious over, Napolitano.8 (Id. at 15.)
I.
Issue
The Examiner has rejected claims 1—4, 7, and 33—36 under 35 U.S.C.
§ 101 as being directed, without significantly more, to a judicial exception to
patentable subject matter. The Examiner finds that the claims relate to
an artificial gland that is an independent unit for promoting
biological activity, the artificial gland comprising: cells
assembled in three dimensions and organized to form a
membrane, the membrane configured to define an enclosed
volume; and, a reservoir within the enclosed volume, the
reservoir comprising a bio-reactor containing a product of
activity of the cells.
(Ans. 3.) The Examiner finds that the remaining limitations of the claims,
such as cells being assembled “in a component selected from the group
consisting of a flow chamber, a microfluidic device, and an inkjet printer,”
“relates to the method of making the gland” and “are not claimed to be part
of the gland.” (Final Act. 5.) Thus, the Examiner finds that such limitations
do not impact the analysis with respect to 35 U.S.C. § 101. (Id.; see also
Ans. 18.)
Based on the above, the Examiner finds that the artificial gland of the
claims reads on “naturally occurring aggregates of cells” such as those
8 Anthony P. Napolitano et al., Dynamics of the Self-Assembly of Complex
Cellular Aggregates on Micromolded Nonadhesive Hydrogels, 13 Tissue
Engineering 2087 (2007).
5
Appeal 2015-007398
Application 12/726,158
disclosed in Zetter, Debnath, and Kirk. (Ans. 3 4.) In particular, the
Examiner finds that Zetter teaches
a 4-day mouse blastocyst containing] two distinct cell types: an
outer layer of trophectoderm that encloses a fluid-filled cavity,
the blastocoel, and the pluripotent [inner cell mass] ICM at one
end of the blastocoel. As shown, the 4 day blastocyst is about
100 microns. The blastocyst comprises cells forming a
membrane around a fluid filled cavity, the blastocoel,
containing proteins secreted by the cells, and additional cells,
the ICM.
{Id. at 4 (citations omitted).) The Examiner also finds that Debnath teaches
the in vitro formation of mammary gland acini possessing a
hollow luminal space surrounded by cells, containing milk
protein secretion products from the cells. The acini is about 50
microns in diameter. The mammary gland acini is comprised of
mammary epithelial cells surrounding a hollow, which would
be air filled, center containing secreted milk proteins and tissue
fluid.
{Id. (citations omitted).) Finally, the Examiner finds that Kirk teaches that
volvox is a spherical multicellular green alga containing many
small biflagellate somatic cells and non-motile gonidia, and
moves by a rolling motion. The volvox spheroid contains
within its core extracellular matrix and juvenile spheroids. The
volvox spheroid is 350-500 microns in size. Thus, the volvox
spheroid is composed of volvox cells that form a membrane
surrounding a gel center that contains cells as well as secreted
volvox proteins, the extracellular matrix. Volvox meets the
limitations of the claims.
{Id. at 4—5 (citations omitted).)
Appellants contend that independent claims 31 and 33 do not recite
cells and thus the Examiner’s rationale with respect to the 35 U.S.C. § 101
6
Appeal 2015-007398
Application 12/726,158
rejection is inapplicable as to those and related claims.9 {Id. at 30, 34.)
With respect to the remaining claims, Appellants contend that the claims are
not directed to natural products (Appeal Br. 29, 31), and that, in any event,
the claims as a whole recite something significantly different than a natural
product. {Id. at 32—38.)
Appellants do not separately argue claims 2-4 and 7. We thus limit
our analysis to claims 1 and 33—36. The issue with respect to this rejection
is whether the evidence of record supports the Examiner’s conclusion that
claims 1 and 33—36 are directed to non-patentable subject matter.
Fact
1. Zetter describes that, “[a]t the blastocyst stage (approximately
64 cells) [a mouse] embryo contains two distinct cell types: an outer layer of
trophectoderm that encloses a fluid-filled cavity, the blastocoel, and the
pluripotent [inner cell mass] ICM at one end of the blastocoel.” (Zetter
2325, right column.)
2. Zetter describes flushing the mouse embryos by standard
procedures from the oviduct or the uterus of a mouse. (Zetter 2324, right
column.)
3. The Examiner finds that “[a]ny protein secreted by the
trophoectoderm [sic] would ... be expected to be found within the
9 The Examiner has stated that claim 31 is not rejected under 35 U.S.C.
§101 and also provides no argument relating to claim 31 with respect to the
35 U.S.C. § 101 rejection. (Ans. 15.) Accordingly, we do not address
Appellants’ argument regarding claim 31 in the context of this rejection.
7
Appeal 2015-007398
Application 12/726,158
blastocoel fluid” and cites Dardik10 as evidence that trophectoderm proteins
are present in blastocoel fluid. (Ans. 30.)
4. Debnath teaches that “[gjlandular epithelial cells, such as those
in the mammary gland, have several distinguishing histological features
including a polarized morphology, specialized cell-cell contacts, and
attachment to an underlying basement membrane.” (Debnath 256, left
column.)
5. Fig. 1A of Debnath is excerpted below:
(Debnath Fig. 1A.) Fig. 1A of Debnath depicts a “[schematic (left) of a
lobule from human mammary gland” and “[a] hematoxylin- and eosin-
stained tissue section (right) of acini within human mammary tissue.”* 11 {Id.
at Fig. 1A caption.) Debnath teaches that “mammary epithelium possesses a
polarized architecture surrounding a hollow lumen, which is surrounded by
an inner layer of luminal epithelial cells and an outer layer of myoepithelial
10 The Examiner did not provide the full citation to Dardik. However, we
understand that the Examiner’s citation is to Alan Dardik et al., Protein
secretion by the mouse blastocyst: differences in the polypeptide
composition secreted into the blastocoel and medium, 45 Biology Reprod.
328 (1991).
11 Acini are epithelial cell-lined “pockets” within the mammary gland that
can expand when filled with milk.
8
Appeal 2015-007398
Application 12/726,158
and basal epithelial cells,” and further teaches that “the lumens of mammary
acini in vivo often contain proteinaceous secretory material.” (Id.)
6. Debnath teaches that “mammary epithelial cells grown in three
dimensions recapitulate numerous features of breast epithelium in vivo,
including the formation of acini-like spheroids with a hollow lumen,
apicobasal polarization of cells making up these acini, the basal deposition
of basement membrane components (collagen IV and laminin V), and, in
some cases, the production of milk proteins.” (Debnath 257, left column;
see also id. at Abstract.)
7. Debnath teaches a specific method of growing mammary
epithelial cells from the MCF-10A cell line in three-dimensional culture.
(Id. at 257, left column (describing MCF-10A cell line); 261—263 (method of
growing three-dimensional culture).)
8. Figure 5D of Debnath is excerpted below:
(Id. at Fig. 5D.) Figure 5D of Debnath depicts “[sjerial confocal cross
sections (x-y axis) through a Day 15 MCF-10A acinus. The schematic
diagrams overlying each section illustrate the relative position of the optical
section with respect to the z axis.” (Id. at Fig. 5D caption.)
9
Appeal 2015-007398
Application 12/726,158
9. Kirk discloses that volvox “is a spherical multicellular green
algae, which contains many small biflagellate somatic cells and a few large,
non-motile reproductive cells called gonidia.” (Kirk R599, column 1.)
10. Kirk discloses that, during asexual reproduction, “mature
gonidium initiates . . . cleavage divisions” to create a “[a] fully cleaved
embryo containing] all of the cells of both types that will be present in an
adult” but that is inside out, which then undergoes inversion to turn right-
side-out. {Id. at R599, column 2.)
11. Kirk discloses that, “[fallowing inversion, both the adult
spheroid and the juvenile spheroids within it increase in size (without further
cell division) by depositing large quantities of a glycoprotein-based
extracellular matrix. Part way through the expansion phase, the juveniles
digest their way out of the parental matrix and become free-swimming.”
(Id.)
12. The sole figure in Kirk is excerpted below:
(Kirk R599.) The figure in Kirk shows “[djarkfield (left) and brightfield
(right) micrographs of a . . . spheroid of Volvox carteri containing many
small somatic cells and a few large, asexual reproductive cells called
gonidia.” {Id.)
10
Appeal 2015-007398
Application 12/726,158
Principles of Law
Patentable Subject Matter
Natural phenomena, including naturally occurring organisms, are not
patentable. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1335—1336
(Fed. Cir. 2014).
In Funk Brothers, “bacteria produced by the laboratory methods of
culture are placed in a powder or liquid base and packaged for sale to and
use by agriculturists in the inoculation of the seeds of leguminous plants.”
Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 129 (1948). The
Supreme Court concluded that such a mixture of bacteria was not patent
eligible: “The qualities of these bacteria, like the heat of the sun, electricity,
or the qualities of metals, are part of the storehouse of knowledge of all men.
They are manifestations of laws of nature, free to all men and reserved
exclusively to none.” Id. at 130; see also In re Roslin Institute (Edinburgh),
750 F.3d at 1336 (explaining that “while the method of selecting the strains
of bacteria [in Funk Brothers'] might have been patent eligible, the natural
organism itself—the mixture of bacteria—was unpatentable because its
‘qualities are the work of nature’ unaltered by the hand of man”) (citation
omitted).
In Chakrabarty, the Supreme Court found that, in contrast to the
mixture of bacteria in Funk Brothers, “the patentee has produced a new
bacterium with markedly different characteristics from any found in nature
and one having the potential for significant utility.” Diamond v.
Chakrabarty, 447 U.S. 303, 310 (1980) (emphasis added).
In Myriad, the Supreme Court held that “extensive effort alone is
insufficient to satisfy the demands of § 101.” Association for Molecular
11
Appeal 2015-007398
Application 12/726,158
Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2118 (2013). The
Court further found that Myriad’s claims, which relate to isolated DNA of
genes that may be examined to determine a person’s risk of developing
breast cancer, id. at 2112—2113, were not “saved by the fact that isolating
DNA from the human genome severs chemical bonds and thereby creates a
nonnaturally occurring molecule”: “Myriad’s claims are simply not
expressed in terms of chemical composition, nor do they rely in any way on
the chemical changes that result from the isolation of a particular section of
DNA.” Id. at 2118.
Finally, in Roslin, the Federal Circuit applied the above Supreme
Court case law and found that claims to a “live-bom clone” of a donor
mammal are not directed to patent-eligible subject matter. Roslin, 750 F.3d
at 1337. In particular, although patent applicants contended that “copies
(clones) are eligible for protection because they are ‘the product of human
ingenuity’ and not ‘nature’s handiwork, but [their] own,”’ the Federal
Circuit found that a clone is not patentable because it is “an exact genetic
replica” of the donor mammal and “does not possess ‘markedly different
characteristics from any [farm animals] found in nature.’” Id. (brackets in
original and citations omitted).
Product-bv-Process Claims
“The patentability of a product does not depend on its method of
production. If the product in a product-by-process claim is the same as or
obvious from a product of the prior art, the claim is unpatentable even
though the prior product was made by a different process.” In re Thorpe,
111 F.2d 695, 697 (Fed. Cir. 1985) (citation omitted).
12
Appeal 2015-007398
Application 12/726,158
Analysis
Claim 1
In light of Supreme Court and Federal Circuit precedent, we agree
with the Examiner that claim 1 is invalid as being directed to non-patentable
subject matter.
We begin by noting that claim 1 is a claim to a product, i.e., an
artificial gland. Thus, while claim 1 recites that cells are “assembled in three
dimensions in a component selected from the group consisting of a flow
chamber, a microfluidic device, and an inkjet printer,” the patentability of
the claim does not depend on such methods of production. In re Thorpe,
III F.2d at 697. Given the above, and as also discussed below in Sections
IV and VI, we agree with the Examiner that claim 1 reads on natural
products, specifically the mouse blastocysts described in Zetter and the
volvox algae described in Kirk.12 (FF1—3, 9-11.)
12 The Examiner finds that claim 1 also reads on the mammary gland acini
described in Debnath, which the Examiner finds to be another example of
naturally occurring structure that cannot be distinguished from the structure
of claim 1. (Ans. 4.) We are not convinced. Claim 1 requires cells
organized to form a membrane, which in turn define an enclosed volume.
Although Debnath does disclose acini-like spheroids that reads on claim 1,
as discussed further below in Section V, such spheroids are not naturally
occurring, but rather grown in three-dimensional culture in vitro. (FF6—
FF8.) In contrast, as depicted in Debnath Figure 1A (left), it is not clear that
the epithelial cells of the naturally occurring mammary gland acini define an
“enclosed” volume, because the epithelial cells do not appear to completely
surround the “lumen.” (FF5.) Thus, we do not rely on Debnath in affirming
the Examiner’s rejection of claim 1 under 35 U.S.C. § 101. Cf. In re Bush,
296 F.2d 491, 496 (CCPA 1961) (the Board may rely on less than ah of the
references relied upon by Examiner).
13
Appeal 2015-007398
Application 12/726,158
Appellants rely on the 2014 Interim Guidance in arguing that the
claims are patentable.13 We address these arguments below.
Appellants first argue that the claims are patentable because they are
directed to a manufacture and composition of matter and because they recite
“artificial assembly ... of cells” that are “assembled in a man-made device.”
(Appeal Br. 29, 31—32.) As already discussed, the specific process by which
the cells are assembled does not confer patentability, because claim 1 is
directed to a product. Given that claim 1 is a product claim, we are also not
persuaded by Appellants’ argument in view of Myriad and particularly
Roslin. In both of those cases, the claimed products—an isolated DNA and
a cloned mammal, respectively—are produced only after significant human
intervention. The isolated DNA of Myriad, for instance, required
“severing] chemical bonds and thereby creating] a nonnaturally occurring
molecule.” Myriad, 133 S. Ct. at 2118. Likewise, the cloned mammal in
Roslin would not have existed without human involvement. Indeed, the
method resulting in the clones claimed in Roslin “constituted a breakthrough
in scientific discovery.” Roslin, 750 F.3d at 1334. The claims in both of
these cases have nevertheless been held to be directed to patent ineligible
products of nature, because they do not possess “markedly different
characteristics” from products found in nature. Id. at 1337 (citation
omitted); Myriad, 133 S. Ct. at 2117.
Appellants next argue that, even if the claims were considered to be
directed to a “natural product,” they are patentable because they recite as a
13 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg.
74,618 (Dec. 16, 2014), available at
https://www.federalregister.gov/articles/2014/12/16/2014-29414/2014-
interim-guidance-on-patent-subject-matter-eligibility.
14
Appeal 2015-007398
Application 12/726,158
whole something significantly different than the natural product. (Appeal
Br. 32—38.) Appellants first contend that the Examiner already admitted that
the claimed artificial gland is “structurally different from a naturally
occurring gland.” {Id. at 32—33.) We are not convinced. As the Examiner
points out, Zetter and Kirk are not directed to naturally occurring glands as
the term gland is conventionally understood. (Ans. 19.) Thus, the
Examiner’s statement is far from an admission that the blastocysts in Zetter
and the volvox algae described in Kirk are structurally different from the
claimed artificial gland.
Appellants also argue that the claims “require a structure that is an
isolated product existing as an independent unit” as well as a
reservoir/bioreactor containing a cell activity product, and that “claim
limitations involving ‘independent unit’ and ‘isolated product’ are not met
by any product found in nature.” (Appeal Br. 34—35, 36—37.) We are not
persuaded. Both Zetter’s blastocysts and the volvox described in Kirk are
independent units that may be isolated. (FF2, FF12.) Furthermore, the
Supreme Court found in Myriad that isolated DNA are not patent eligible,
even though such isolated DNA are not found in nature. Myriad, 133 S. Ct.
at 2118.
Appellants next argue that, “[ijmplicit in this requirement [that cells
be assembled into a membrane in a component selected from the group
consisting of a flow chamber, a microfluidic device, and an inkjet printer,]
is [a requirement] that the cells ... be structurally fit in order to survive
assembly in these machines.” (Appeal Br. 35.) We are not persuaded.
Appellants provide no persuasive evidence to support the claim that the cells
of the claimed artificial gland are more “structurally fit” than those in the
15
Appeal 2015-007398
Application 12/726,158
cellular aggregates disclosed in Zetter and Kirk. In re Pearson, 494 F.2d
1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the
place of evidence.”). Furthermore, Appellants do not suggest that the
assembly devices render the cells more structurally fit, and neither the
claims nor the Specification suggests any method of treating the cells to
render it sufficiently “structurally fit” to survive in machine assembly. Thus,
the structural integrity Appellants suggest to be a distinguishing
characteristic is nevertheless natural.
Appellants reiterate that the claims require cells be assembled into a
membrane in a man-made device and argue that, “[e]ven if the assembly
machines are not considered as imbuing any structure to the artificial gland,”
they impose “meaningful limits on claim scope that avoid substantially
foreclosing the use of any natural product.” (Appeal Br. 35—36.) As already
discussed, this argument is not persuasive in light of Myriad and particularly
Roslin.
Finally, with respect to whether a “[cjlaim recites one or more
elements/steps in addition to the judicial exception(s) that add a feature that
is more than well-understood, purely conventional or routine in the relevant
field,” Appellants contend that the claims “require a unique combination of
materials to create a unique product not before seen or available to enable
unique research capabilities and unique treatment possibilities.” (Appeal Br.
38.) Such generic attorney argument, without supporting evidence, does not
suffice to render the claims patent eligible. In re Pearson, 494 F.2d at 1405.
Claims 33 and 34
Claims 33 and 34 require the claimed artificial gland to comprise
“components of a cell assembled in three dimensions and organized to form
16
Appeal 2015-007398
Application 12/726,158
a membrane.” (Appeal Br. 97 (Claims App’x) (emphasis added).)
Appellants contend that claims 33 and 34 do not recite cells and thus the
Examiner’s rationale with respect to the 35 U.S.C. § 101 rejection is
inapplicable as to these claims. {Id. at 30, 34.) The Examiner responds that
“an artificial gland produced by a membrane of cells[] is produced by a
membrane of cellular components,” because “[cjlaims 33 and 34 do not
require the cell components to be isolated.” (Ans. 20.)
We find Appellants have the better argument. The Specification
describes the embodiment relating to claims 33 and 34 as one in which
“components of a cell are used instead of cells.” (Spec. 1 59.) Thus, we are
not persuaded that an artificial gland comprising “components of a cell. . .
organized to form a membrane” reads on aggregates of intact cells such as
the blastocyst and volvox described respectively in Zetter and Kirk.
Claim 35
Appellants argue that claim 35 is not directed towards a product of
nature because no naturally occurring product anticipates or renders obvious
the artificial gland recited in claim 35. (Appeal Br. 30.) We are not
persuaded because we find that volvox, an algae that occurs in nature,
anticipates claim 35, as further discussed below in connection with the
rejection of claim 35 under 35 U.S.C. § 102 as anticipated by Kirk.
Claim 36
Appellants argue that claim 36 is not directed towards a product of
nature because no naturally occurring product anticipates or renders obvious
the artificial gland recited in claim 36. (Appeal Br. 30.) We find Appellants
have the better argument. Although the Examiner contends that Zetter,
Debnath, and Kirk all disclose “naturally occurring structures that cannot be
17
Appeal 2015-007398
Application 12/726,158
distinguished from the structure in claims 1—4, 7, and 33—36,” the Examiner
has provided no citation to the cited references wherein a specified type of
“organized algae micro-colony” is naturally found within a volume enclosed
by a membrane formed of cells, as required by claim 36.
Accordingly, we affirm the Examiner’s rejection of claims 1 and 35
and reverse the Examiner’s rejection of claims 33, 34, and 36 under
35 U.S.C. § 101. Claims 2—\ and 7, which were not separately argued, fall
with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
II.
Issue
The Examiner has rejected claims 1—5, 7, 8, and 13 under 35 U.S.C.
§ 112(a)or35U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply
with the written description requirement. Citing to paragraph 45 of the
Specification, the Examiner finds the Specification states “the artificial
gland is an independent unit and an isolated product,” in contrast to the
artificial gland as claimed, which is “made up of an independent unit and
something else, where the independent unit consists of an isolated product,
the product being undefined.” (Ans. 6.)
Appellants appear to agree that the Specification “explains that the
artificial gland is the ‘isolated product’ and is an ‘independent unit.’”
(Appeal Br. 40.) Appellants argue, however, that “in view of the
explanation in the description, a reasonable interpretation of claim 1 would
require that the claimed ‘artificial gland’ is made up as an ‘independent
unit,’ which because of the transitional phrase ‘comprising’ is an essential,
(not an optional) feature” and which further “may not be other than an
‘isolated product.’” {Id. at 40-41; Reply Br. 32.) Appellants contend that
18
Appeal 2015-007398
Application 12/726,158
the Examiner disregarded the “plain meaning of ‘independent unit’ as a state
of being and not as a thing or component in plain view of the express
provision in the specification.” (Reply Br. 34.) Appellants further argue
that “[t]he adequacy of the written description was attested to by a third
party declaration.” (Appeal Br. 42.)
Appellants do not separately argue the claims, and we 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 the Specification
does not describe an artificial gland “comprising” an independent unit.
Findings of Fact
13. The Specification discloses “[a]n artificial gland ... in the form
of an independent unit for promoting biological activity.” (Spec. 111.)
14. The Specification states,
In its simplest form, the first artificial gland embodiment
(100) is essentially first cells (110) surrounding a first reservoir
(105) and is an independent micro-scale unit for promoting
biological activity.
For all of the embodiments, the artificial gland, as an
independent unit, is an isolated product that can be assembled
into tissue, organs, or other biological supportive material.
Preferably, the artificial gland is in the micron size range of
about 10-500 microns. However, larger embodiments up to a
centimeter and beyond in diameter are theoretically possible.
(Spec. 44^45.)
Principles of Law
A description adequate to satisfy 35U.S.C. § 112, first paragraph,
must “clearly allow persons of ordinary skill in the art to
recognize that [the inventor] invented what is claimed.” In
19
Appeal 2015-007398
Application 12/726,158
other words, the test for sufficiency is whether the disclosure of
the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject
matter as of the filing date.
AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(en banc) (citation omitted, alteration in original).
The Examiner “bears the initial burden ... of presenting a prima facie
case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir.
1992).
Insofar as the written description requirement is concerned, that
burden is discharged by “presenting evidence or reasons why
persons skilled in the art would not recognize in the disclosure a
description of the invention defined by the claims.”. . . If the
applicant claims embodiments of the invention that are
completely outside the scope of the specification, then the
examiner . . . need only establish this fact to make out a prima
facie case.
In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996) (citation omitted).
Analysis
As set forth above, claim 1 recites an artificial gland “comprising an
independent unit for promoting biological activity,” the independent unit
“consisting of an isolated product,” and the artificial gland “further
comprising” cells organized to form a membrane defining an enclosed
volume and a reservoir within the enclosed volume comprising a bio-reactor
containing a product of activity of the cells.
We agree with the Examiner that claim 1 encompasses embodiments
outside of the scope of the Specification. In particular, the Specification
only describes an artificial gland that is an independent unit and an isolated
product. (FF13, FF14.) In using the open transitional phrase “comprising,”
20
Appeal 2015-007398
Application 12/726,158
however, claim 1 encompasses artificial glands that include an independent
unit that is an isolated product, but need not themselves be independent units
or isolated products.
We note but are not convinced by Appellants’ argument that the
Examiner’s construction of the claim is unreasonable. (Appeal Br. 40-41;
Reply Br. 31—34.) While claims are read in light of the Specification,
“[cjlaim language itself sets the claim scope.” Crystal Semiconductor Corp.
v. TriTech Microelectronics Intern., Inc., 246 F.3d 1336, 1347 (Fed. Cir.
2001). “When a patent claim uses the word ‘comprising’ as its transitional
phrase,” as claim 1 does here, “the use of ‘comprising’ creates a
presumption that the body of the claim is open. In the parlance of patent
law, the transition ‘comprising’ creates a presumption that the recited
elements are only a part of the device, that the claim does not exclude
additional, unrecited elements.” Id. at 1348. The Examiner’s construction
of the claim is consistent with this general tenet of claim construction.
We are likewise unpersuaded by Appellants’ argument that “[t]he
adequacy of the written description was attested to by a third party
declaration” because the Cheng Declaration14 allegedly “point[ed] to peer[]
reviewed scientific reports on the manufacture and use of the artificial gland
to be supportive of the operability, functionality and usefulness of the
claimed artificial gland.” (Appeal Br. 42.) As an initial matter, the
“operability, functionality and usefulness” of the claimed invention does not
14 Declaration of Zhengdong Cheng under 37 C.F.R. § 1.132 (Oct. 25, 2012)
(“Cheng Declaration”). 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.
21
Appeal 2015-007398
Application 12/726,158
show that the “disclosure of the application . . . reasonably conveys to those
skilled in the art that the inventor had possession of the claimed subject
matter as of the filing date.” Ariad Pharms., 598 F.3d at 1351 (emphasis
added). Furthermore, the generic statement in the Cheng Declaration was
not supported by analysis of how any of the cited reports is supportive of the
operability, functionality and usefulness of the claimed invention. Opinions
on ultimate legal issues are not entitled to weight absent supporting
evidence. In re Reuter, 670 F.2d 1015, 1023 (CCPA 1981) (expert’s opinion
on ultimate legal issue entitled to no weight).
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 written description requirement. Claims 2—5, 7, 8, and
13, which were not separately argued, fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
III.
Issue
The Examiner has rejected claims 1—5, 7, 8, 13, and 31—36, because
“[t]he specification does not provide guidance for producing or using the
claimed artificial gland.” (Ans. 8.) The Examiner finds that a gland is “an
organ or a tissue that produces and secretes proteins, enzymes or hormones
. . . either constitutively or regulated by a signal from outside the gland.”
(Id.) The Examiner finds that the claims are not enabled because the
claimed structure “lacks the mechanism for either constitutive release or
regulated release” and because the Specification fails to provide guidance
for obtaining such release. (Id. at 9—10.) The Examiner finds that there is
no enablement commensurate with the full scope of the claims, because the
22
Appeal 2015-007398
Application 12/726,158
claimed reservoir can be water, gas, or gel, but the Specification “provides
no guidance as to the type of gas that would solubilize proteins, enzymes or
hormones.” (Id.) The Examiner further finds that the claims are not enabled
because the Specification fails to provide guidance as to how to overcome
any immune response to the claimed structure or how to obtain organ
regeneration either in vivo or in vitro through use of the claimed structure.
(Id. at 10.) Finally, the Examiner finds that claims 33 and 34 further lacks
enablement because the Specification “does not provide guidance for the
formation of an artificial gland that contains a membrane of cellular
components,” 15 as required by these claims, or how such a gland may be
used “for drug testing, tumor biology and organ/tissue regeneration or
replacement” as disclosed in the Specification. (Id. at 11—12.)
With respect to claims 33 and 34,16 Appellants argue that the
Examiner erroneously assumes without basis that self-aggregation to form a
membrane is cell-dependent. (Appeal Br. 44-45.) Appellants did not
address the enablement rejection of the remaining claims in the Appeal
Brief, but argue in the Reply Brief that the enablement requirement is
satisfied with respect to the term “artificial gland” because of “the potential
of a group of cells making up the shell to deliver the contents of the
15 Both the Examiner and Appellants direct their arguments relating to
formation of an artificial gland using components of a cell to claims 31 and
32. (Ans. 11—12; Appeal Br. 44-45.) As the Examiner points out in
response to Appellants’ arguments, however, such arguments appear
properly directed towards claims 33 and 34. (Ans. 26.) Appellants did not
dispute this characterization of the arguments in the Reply Brief;
accordingly, we analyze these arguments as though they are directed towards
claims 33 and 34.
16 See supra note 13.
23
Appeal 2015-007398
Application 12/726,158
reservoir” and in view of an expert declaration17 that purportedly “point[s] to
peer[] reviewed scientific reports on the manufacture and use of the artificial
gland [that are] supportive of the operability, functionality and usefulness of
the claimed artificial gland.” (Reply Br. 34—36 (citing Appeal Br. 41—43).)
Appellants also argue that the Examiner’s construction of the term “gland” is
unduly narrow. {Id. at 35—36.) With respect to the Examiner’s argument
that the enablement is not commensurate with the scope of the claims
because the Specification does not enable a “reservoir” that is a gas,
Appellants argue that the Specification teaches a method of making the
artificial gland wherein a gas is introduced into a microchannel, and further
argue that there is no requirement that the claimed reservoir “solubilizes
proteins” as suggested by the Examiner. {Id. at 36—37.) Finally, Appellants
argue that the Examiner has cited no evidence that undue experimentation
would be needed to implement the invention as claimed. {Id. at 37.)
The issue with respect to this rejection is whether the evidence of
records supports the Examiner’s conclusion that the Specification does not
enable a skilled artisan to make and use the claimed artificial gland.
Findings of Fact
15. The Specification states that an artificial gland is
a “living capsule” with a biomembrane (tissue) shell and a
unique core that acts as container or reservoir. . . . The
reservoir is a bio-reactor capable of containing a product of
activity of the cells. The reservoir preferably comprises a gas, a
liquid, or a gel and preferably also contains nanoparticles, a
buffer, a surfactant, and, a gel precursor. The reservoir may
17 Appellants do not reference a specific expert declaration; however, we
assume Appellants to be referring to the previously discussed Cheng
Declaration.
24
Appeal 2015-007398
Application 12/726,158
also contain cells. Nanoparticles may also surround the
artificial gland to form a protective coating.
(Spec. Ill; see also id. at || 18—19, 26.)
16. The Specification states that “[t]he contents of the bio-reactor
preferably include a substance comprising a fluid in the form of a gas, liquid,
gel, or a combination of these.” {Id. at 148.)
17. The Specification 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; see also id. at || 3, 7, 13—16,
21, 27—28, 53, 168, 169, 173—175, 214, 220.) In particular, the Specification
states that the artificial gland “is capable of being used to support the growth
of organs and other biological material without the use of macro-scale
scaffolds” and “can control the 3-dimensional arrangements of cells and
subcellular systems in such a way that can mimic nature.” {Id. at 118; see
also id. at || 20-24, 28 (application to 3-D in vitro cell cultures), 52
(“[sjhape variability [of artificial gland] . . . broadens the parameter-space
for the design of any type of artificial tissue, and can help to direct strategies
for all types of tissue engineering”), 56, 149.) The Specification further
indicates that claimed artificial glands have applications in the treatment of
diseases. {Id. at H 56, 171, 178-180, 189, 194, 207, 209-210.)
18. The Specification states that “[the] artificial glands with a
membrane of cells and a central reservoir . . . create opportunities to trigger
events that can lead to . . . vehicles for food and pharmaceutical
applications.” {Id. at 113; see also id. at || 21, 23, 25 (“new means for
manipulating controlled releases or absorptions supporting biological
activity,” “tuning rheological or optical properties of cosmetics, foods, or
25
Appeal 2015-007398
Application 12/726,158
other fluids,” and “functionaliz[ation] for a specific biological tasking”),
149-152.)
19. The Specification indicates that the claimed artificial glands
have applications in drug or therapy screening and in modeling disease states
for study. {Id. at H 56, 170, 172, 176, 211-213.)
20. The Specification states,
An alternative embodiment of the artificial gland uses the
same configuration and components as described above, except
that biological units are used instead of cells. The biological
units form a membrane. . . . Biological units are similar in that
they perform a biological activity that produces products, but
they may not be classified as living. Biological units include
fungi, algae, spores, pollen, yeast, bacteria, and viruses.
An alternative embodiment of the artificial gland uses the
same configuration and components as described above, except
that components of a cell are used instead of cells. The
components of a cell form a membrane assembled in three
dimensions. . . . Components of a cell are similar in that they
perform a biological activity that produces products, but they
are not classified as living. Examples of components of a cell
are: enzymes, prions, hormones, growth factors, Tumor
Necrosis Factor-alpha, Tumor Necrosis Factor-beta, cytokines,
interleukins, albumin-scavengers, polyclonal-anti-bodies,
monoclonal-anti-bodies, immunoglobulines, protease enzymes,
lysosomes, vesicles, cell membranes, rough endoplasmic
reticulums, smooth endoplasmic reticulums, mitochondria,
ribosomic ribonucleic acid, transference ribonucleic acid,
deoxyribonucleic acid, mitrotubules, endocrine cells, and
human T-cells, fatty acids, beta-OH-butirate, acetoacetate,
polycations, poly F lisine, ornithine, chitosan, oligoelements,
genes, chloroplasts, chlorophyll, glucidic elements.
{Id. at 11 58-59.)
26
Appeal 2015-007398
Application 12/726,158
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
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 the 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
27
Appeal 2015-007398
Application 12/726,158
addition to providing a ‘substantial’ utility, an asserted use must show that
th[e] claimed invention can be used to provide a well-defined and particular
benefit to the public.” 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
Appellants address only claims 33 and 34 in its Appeal Brief with
respect to the enablement rejection; accordingly, we limit our analysis of this
rejection to these two claims and summarily affirm the Examiner’s
enablement rejection of claims 1—5, 7, 8, 13, 31, 32, 35, and 36.18
18 Appellants make additional arguments that are applicable to the other
rejected claims in their Reply Brief. These arguments are waived, however,
because they were not presented in the opening brief, thereby denying the
Board the benefit of the Examiner’s response, and no showing of good cause
was made by Appellants to explain why the late argument should be
considered by the Board. See 37 C.F.R. § 41.41(b)(2); Cf. Optivus
Technology, Inc. v. Ion Beam Applications S.A., 469 F.3d 978, 989 (Fed. Cir.
2006) (argument raised for the first time in the Reply Brief that could have
been raised in the opening brief is waived).
28
Appeal 2015-007398
Application 12/726,158
Claim 33 requires the claimed artificial gland to comprise
“components of a cell assembled in three dimensions and organized to form
a membrane.” (Appeal Br. 97 (Claims App’x).) Claim 34, which depends
from claim 33, clarifies that the components of the cell encompassed within
claims 33 and 34 include, among others:
enzymes, prions, hormones, growth factors, Tumor Necrosis
Factor-alpha, Tumor Necrosis Factor-beta, cytokines,
interleukins, albumin-scavengers, polyclonal-anti-bodies,
monoclonal-anti-bodies, immunoglobulines [sic], protease
enzymes, lysosomes, vesicles, cell membranes, rough
endoplasmic reticulums, smooth endoplasmic reticulums,
mitochondria, ribosomic ribonucleic acid, transference
ribonucleic acid, deoxyribonucleic acid, mitrotubules [sic
microtubules ?], endocrine cells, and human T-cells, fatty acids,
beta-OH-butirate [sic butyrate], aceto acetate, polycations, poly
L lisine [sic lysine], ornithine, chitosan, oligoelements, genes,
chloroplasts, chlorophyll, [and] glucidic elements.
{Id. at 97-98.)
We agree with the Examiner that claims 33 and 34 fail to satisfy the
enablement requirement because the Specification “does not provide
guidance for the formation of an artificial gland that contains a membrane of
cellular components” or how such a gland may be used “for drug testing,
tumor biology and organ/tissue regeneration or replacement” as disclosed in
the Specification. (Ans. 11—12.) We note that there are no working
examples of an artificial gland comprising a membrane of cellular
components,19 and only minimal, if any, other direction or guidance in the
19 While the Specification discloses “a method of artificial gland production
implemented as a proof of concept,” the method uses cells (specifically yeast
cells) rather than cell components. (Spec. 177; see also id. at 1215 (stating
that “[a]n artificial gland constructed with a fibroblast membrane has been
constructed for testing the invention”), 1169 (stating that “[a]rtificial micro-
29
Appeal 2015-007398
Application 12/726,158
Specification regarding how to make a membrane composed from other
cellular components. In re Wands, 858 F.2d at 737 (describing factors to be
considered in determining enablement). Furthermore, none of the prior art
cited by the Examiner describes such a membrane of cellular components,
and the scope of the claims 33 and 34 is extremely broad, encompassing
components as divergent as genes and chlorophyll. Id.
Appellants argue that the Specification “explains that the mechanism
forming the artificial gland using components of a cell operates in the same
way as for cells,” “indicates that the mechanism employed is non-cellular
dependent,” and “explains that self-aggregation may be aided by the ability
to control non-cellular-related physical factors associated with the assembly
environment.” (Appeal Br. 44-45.) We are not persuaded. While we
understand Appellants assert that the same basic factors of, e.g.,
minimization of interfacial energy and electrostatic interaction, affect the
formation of a membrane composed of cellular components as well as that
composed of cells, the Specification provides no support that such factors
would affect cells and all the claimed cellular components in the same way
so as to lead to creation of a membrane. Neither does the Specification
provide any guidance on how such factors should be adjusted in view of the
differences between cells and the many different types of cellular
components claimed.
Appellants further argue that “[t]he embodiments involving
components of cells may be used in many of the same research activities as
glands were suspended separately in a concentrated phosphate buffered
saline solution [and] subsequently printed as a kind of ‘ink’ onto several
[Jbiopapers made from soy agar and collagen gel”).)
30
Appeal 2015-007398
Application 12/726,158
other embodiments.” (Id. at 45 46.) We are likewise not persuaded.
Appellants’ broad statements regarding potential use of the claimed artificial
glands (FF17—19) do not describe the “specific and substantial” utility
needed to satisfy the enablement requirement. Generic statements that the
claimed artificial gland is useful for “biological tissue and organ repair and
replacement,” “stem cell engineering,” “biotechnology applications,”
“treatment of diseases,” “vehicles for food and pharmaceutical applications,”
or “applications in drug or therapy screening and in modeling disease states
for study” 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 claimed 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 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.” (Spec. 121 (emphasis added).)
Finally, while working examples are not necessary to satisfy
enablement, they are desirable in complex technologies, and we note that the
Specification provides no such examples of using the claimed artificial
gland. 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
31
Appeal 2015-007398
Application 12/726,158
data demonstrating the claimed [inventions] were actually put to the alleged
uses”).
Accordingly, we affirm the Examiner’s rejection of claims 1—5, 7, 8,
13, and 31-36 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.
IV.
Issue
The Examiner rejects claims 1, 2, 4, 7, 33, and 34 under pre-AIA
35 U.S.C. § 102(b) as anticipated by or, in the alternative, under pre-AIA
35 U.S.C. § 103(a) as obvious over, Zetter. As discussed above, the
Examiner finds that Zetter teaches a mouse blastocyst containing an outer
layer of trophectoderm cells enclosing a fluid-filled cavity (the blastocoel),
with the pluripotent ICM at one end of the blastocoel. (Ans. 13.) The
Examiner finds that “[n]o distinction between the mouse blastocyst taught
by Zetter and the claimed invention [exists,]” because Zetter’s blastocyst
“comprises cells forming a membrane around a fluid filled cavity, the
blastocoel, containing proteins secreted by the cells, [together with]
additional cells, the ICM.” (Id. at 13—14.)
Appellants contend that Zetter does not teach that the fluid-filled
cavity of the blastocyst contains any product of the trophectoderm. (Appeal
Br. 47.) Appellants also contend that the blastocyst disclosed in Zetter is not
“an independent unit” or “an isolated product.” (Id. at 49—50.) Appellants
further contend that Zetter does not teach an artificial gland with the
structural limitations implicit in the claimed method of assembly. (Id. at 51—
52.) Citing Chakrabarty, the Specification, various news articles, and the
32
Appeal 2015-007398
Application 12/726,158
Cheng Declaration, Appellants further argue that the invention “involves a
manufactured or artificial gland with ‘markedly different characteristics’”
than natural products, including “robust tissue structural characteristics that
enable many uses not found in nature.” {Id. at 53—56.) Finally, Appellants
contend that Zetter does not disclose a membrane made of “components of a
cell” as required by claims 33 and 34.20 {Id. at 48.)
Appellants do not separately argue claims 2, 4, and 7, and we
therefore limit our analysis to claims 1, 33, and 34. The issue with respect to
this rejection is whether the evidence of record supports the Examiner’s
conclusion that claims 1, 33, and 34 are anticipated or rendered obvious by
Zetter.
Analysis
Claim 1
As an initial matter, claim 1 is directed to a product (i.e., an artificial
gland), even though it also recites limitations regarding the process used to
create such a product. As noted earlier, “[t]he patentability of a product does
not depend on its method of production. If the product in a product-by­
process claim is the same as or obvious from a product of the prior art, the
claim is unpatentable even though the prior product was made by a different
process.” In re Thorpe, 111 F.2d at 697. Zetter discloses all of the structural
limitations of claim 1; accordingly, the evidence of record supports the
Examiner’s finding that Zetter anticipates claim 1.
20 Appellants also argue that Zetter does not disclose the volvox algae and
algae micro-colony required by claims 35 and 36. (Appeal Br. 49.) The
Examiner has removed claims 35 and 36 from the anticipation rejection over
Zetter. (Ans. 30.) Accordingly, we do not address Appellants’ arguments
regarding claims 35 and 36 with respect to this rejection.
33
Appeal 2015-007398
Application 12/726,158
Zetter teaches a mouse blastocyst containing an outer layer of
trophectoderm cells enclosing a fluid-filled cavity (the blastocoel), with the
pluripotent ICM at one end of the blastocoel. (FF1.) Thus, Zetter teaches
cells assembled in three dimensions and organized to form a membrane (i.e.,
the trophectoderm), with the membrane configured to define an enclosed
volume (i.e., the blastocoel). Furthermore, the blastocyte is an independent
unit and an isolated product within the broadest reasonable interpretation of
those terms, as Zetter describes isolating them from the oviduct or uterus of
the mouse. (FF2.) Given the substantial identity between the structure
described in Zetter and the claimed structure, we also find that the Examiner
has established a prima facie case that the blastocoel contains a product of
the activity of the cells in the trophectoderm. In re Spada, 911 F.2d 705,
708 (Fed. Cir. 1990) (explaining that “when the PTO shows sound basis for
believing that the products of the applicant and the prior art are the same, the
applicant has the burden of showing that they are not”). Neither have
Appellants disputed in the Reply Brief the Examiner’s citation to Dardik as
evidence that the blastocoel in Zetter’s blastocyst contains trophectoderm
proteins. (Ans. 30.)
Zetter studies the expression of LETS protein in mouse embryos.
(Zetter Abstract.) Appellants contend that Zetter teaches that the LETS
protein is not produced by the trophectoderm and that Zetter thus does not
disclose “a reservoir . . . containing a product of activity of the cells.”
(Appeal Br. 47—48.) We are not persuaded because the Examiner finds that
the blastocoel contains other, non-LETS proteins that are produced by the
trophectoderm (Ans. 30), and, as discussed, Appellants have not disputed
this finding in the Reply Brief.
34
Appeal 2015-007398
Application 12/726,158
Appellants also contend that Zetter does not teach an artificial gland
with the structural limitations achieved by the claimed method of assembly.
(See generally Appeal Br. 50-56.) Appellants first argue that the Examiner
is inconsistent in simultaneously finding that “the artificial gland claimed
cannot be distinguished from a naturally occurring gland” and that “[t]he
present claims are not enabled because it is structurally dissimilar from a
naturally occurring gland in that the structure lacks the mechanism for
either constitutive release or regulated release.” (Id. at 50.) We are not
persuaded. As the Examiner points out, regardless of whether Zetter’s
blastocyst or the claimed structure is referred to as a “gland” and whether
each may be considered structurally similar to a “naturally occurring gland,”
the significant point for purposes of the anticipation rejection is that Zetter
discloses all of the structural limitations recited in the claims. (Ans. 32.)
Neither are we convinced by Appellants’ reliance on Chakrabarty, the
Specification, various news articles, the Cheng Declaration, and attorney
argument in contending that the invention “involves a manufactured or
artificial gland with ‘markedly different characteristics’” than natural
products, including “robust tissue structural characteristics that enable many
uses not found in nature.” (Appeal Br. 53—56.) As further discussed below,
while we agree that claim 1 may be patentable over Zetter if the method of
production recited in the claim in fact results in structural differences,
Appellants have not provided persuasive evidence that such structural
differences exist.21
21 For this reason, Appellants’ citation to Chakrabarty is unavailing. The
artificial, genetically engineered microorganism in Chakrabarty was
genetically distinct (i.e., structurally different) from the naturally occurring
microorganism. Chakrabarty, 447 U.S. at 305, 309—310.
35
Appeal 2015-007398
Application 12/726,158
With respect to Appellants’ argument that “the limitation specifying
how the cells are assembled ... is an implicit structural limitation because
qualifying cells must be structurally viable to withstand the relatively fast
acting assembly mechanism,” we note that “[attorney’s argument in a brief
cannot take the place of evidence.” In re Pearson, 494 F.2d at 1405. For
the same reason, we are not persuaded by Appellants’ citation to the
Specification regarding the ability of the claimed gland to “eliminate [] the
need for a macro-scale tissue-shaping scaffold” and argument in the brief
that “[n]o natural product has tissue structural characteristics that eliminate
the need for a scaffold and such characteristics are only manifest if the
manufactured object is both an independent unit and an isolated product.”
(Appeal Br. 54.)
Neither do the cited news articles and the Cheng Declaration provide
evidence of any structural difference between the claimed artificial gland
and Zetter’s blastocyst. The news articles provide generic descriptions of
“celloidosomes,” which Appellants contend are the subject of the claims.
Likewise, while the Cheng Declaration states that “[fjungi, [ajlgae,
[bjacteria and also a diverse group of mammalian cells . . . can be ‘self-
assembled’ on gas-liquid interfaces of microbubbles, to form stable micro­
core/shell tissues as described ... in [the] patent application” (Cheng Decl.
2), and that “the artificial gland produced with algal and bacterial cells do
form membranous (tissue and/or biofilm) structure and . . . secrete products
of the cells from and into the core (reservoir) when used in vitro” {id. at 4),
36
Appeal 2015-007398
Application 12/726,158
such statements do not support Appellants’ contention that the resulting
artificial gland differs structurally from Zetter’s blastocyst.22
Finally, we note, but are not persuaded by, Appellants’ argument that
the blastocyst disclosed in Zetter is not “an independent unit” or “an isolated
product.” (Appeal Br. 49-50.) As already discussed above, the blastocyst
described in Zetter is isolated from the oviduct or uterus of the mouse.
(FF2.)
Claims 33 and 34
With respect to claims 33 and 34, we find Appellants to have the
better argument. As discussed earlier, these claims require “components of a
cell” assembled in three dimensions and organized to form a membrane.
(Appeal Br. 97 (Claims App’x; emphasis added).) The Examiner argues that
claims 33 and 34 read on intact trophectoderm cells surrounding blastocoel
fluid because “there is no requirement the components be isolated” and
trophectoderm cells are made of cell components. (Ans. 30.) As also
discussed above, however, the Specification describes the embodiment as
one in which “components of a cell are used instead of cells.” (Spec. 1 59
(emphasis added).) Thus, we are not persuaded that the limitation
“components of a cell. . . organized to form a membrane” reads on a
membrane formed from intact cells.
Accordingly, we affirm the Examiner’s rejection of claim 1 as
anticipated by Zetter but reverse the rejection of claims 33 and 34 on this
22 As already discussed, opinions in the Cheng Declaration on ultimate legal
issues, such as the statement that “the claimed artificial gland [is] a unique
innovation,” are not entitled to weight absent supporting evidence. In re
Reuter, 670 F.2d at 1023.
37
Appeal 2015-007398
Application 12/726,158
ground. Claims 2, 4, and 7, which were not separately argued, fall with
claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
Issue
V.
The Examiner rejects claims 1, 2, 4, 7, 33 and 34 under pre-AIA
35 U.S.C. § 102(b) as anticipated by or, in the alternative, under pre-AIA
35 U.S.C. § 103(a) as obvious over, Debnath. The Examiner finds that
Debnath teaches the in vitro formation of mammary
gland acini possessing a hollow luminal space surrounded by
cells, containing milk protein secretion products from the cells.
The acini are about 50 microns in diameter. The mammary
gland acini is comprised of mammary epithelial cells
surrounding a hollow, which would be air filled, . . . containing
secreted milk proteins and tissue fluid. No distinction [exists]
between the mammary gland acini taught by Debnath and the
claimed invention. Thus, Debnath anticipates or makes obvious
the claimed invention.
(Ans. 14 (citations omitted).)
Relying on essentially the same citations and arguments they relied on
with respect to the rejection over Zetter, Appellants contend that Debnath
does not teach an “artificial” gland and does not teach the structural
limitations implicit in the claimed method of assembly. (Appeal Br. 66—71.)
Appellants further argue that Debnath does not teach “a cellular membrane
surrounding a reservoir that contains a product of activity of the cells of the
membrane.” (Appeal Br. 64—65.) Finally, Appellants contend that claim 33
does not recite membrane formed from cells and that the Examiner’s
38
Appeal 2015-007398
Application 12/726,158
rationale as to anticipation by or obviousness over Debnath is thus
inapplicable as to this claim.23 {Id. at 63; Reply Br. 38—39.)
Appellants do not separately argue claims 2, 4, and 7, and we limit our
analysis to claims 1, 33, and 34. The issue with respect to this rejection is
whether the evidence of record supports the Examiner’s conclusion that
claims 1, 33, and 34 are anticipated or rendered obvious by Debnath.
Analysis
Claim 1
The evidence of record supports the Examiner’s finding that Debnath
anticipates claim 1. Debnath discloses a method of growing mammary
epithelial cells from the MCF-10A cell line in three-dimensional culture.
(FF7.) Debnath teaches that mammary epithelial cells grown in three
dimensions form “acini-like spheroids with a hollow lumen.” (FF6, FF8.)
Accordingly, Debnath teaches cells assembled in three dimensions and
organized to form a membrane (i.e., the outer cellular layer of the acini-like
spheroid), with the membrane configured to define an enclosed volume (i.e.,
the hollow lumen). Furthermore, the acini-like spheroid is an independent
unit and an isolated product within the broadest reasonable interpretation of
those terms. (FF8 (depicting confocal cross sections of an individual acini­
like spheroid).) Given the substantial identity between the structure
described in Debnath and the claimed structure, we also find that the
Examiner has established a prima facie case that the lumen of the acini-like
23 Claim 34 depends from claim 33; thus, we address claims 33 and 34
together. Appellants makes similar arguments with respect to claim 31.
(Appeal Br. 63.) However, the Examiner does not appear to have rejected
claim 31 over Debnath, and we do not address arguments relating to claim
31 here.
39
Appeal 2015-007398
Application 12/726,158
spheroid contains a product of the activity of the cells. In re Spada, 911
F.2d at 708. In addition, Debnath teaches that “the lumens of mammary
acini in vivo often contain proteinaceous secretory material” and further
teaches that, at least in some cases, mammary epithelial cells grown in three
dimensions produces milk proteins. (FF5, FF6.)
As they do with Zetter and relying on essentially the same citations to
Chakrabarty, the Specification, various news articles, and the Cheng
Declaration, Appellants contend that Debnath does not teach an artificial
gland having the structural limitations implicit in the claimed method of
assembly. (Appeal Br. 66—67.) These arguments are not persuasive for
similar reasons as those discussed above with respect to the rejection over
Zetter. Furthermore, Appellants do not explain why Debnath’s cells grown
in culture would not be considered “artificial” rather than a “natural
product.” {Id. at 66.)
As further discussed below, we are also not persuaded by Appellants’
arguments that “[t]he human mammary tissue shown in Debnath Fig. 1A is
not an encircling cellular membrane,” that Debnath’s acini lumens are not
reservoirs within the meaning of the claim, and that Debnath does not teach
“a cellular membrane surrounding a reservoir that contains a product of
activity of the cells of the membrane.” {Id. at 64—65.)
While Appellants argue that Debnath’s Figure 1A does not show an
encircling membrane, Figure 5, which provides “[representative confocal
microscopic imaging of MCF-10A acini,” shows that the mammary
epithelial cells do in fact form a sphere that completely enclose the lumen
when they are grown in three-dimensional culture. (FF8.) For the same
reason, Appellants’ citation to Merriam-Webster for the definition of lumen,
40
Appeal 2015-007398
Application 12/726,158
and the corresponding argument that a lumen is “a tubular cavity” and thus
not a “reservoir enclosed by a cellular membrane” is unavailing. Appellants
have not pointed out a structural difference between the lumen disclosed in,
e.g., Fig. 5 of Debnath, and the reservoir recited in claim 1 and described in
the Specification. (See also Spec. 147 (“The shape of th[e] configuration
[of membrane formed from a plurality of cells] may be spherical, spheroidal,
discoid, cylindrical, tubular or any other three-dimensional shape that
physically defines an internal micro-scale volume.”).)
Finally, to the extent Appellants are making a separate argument that
Debnath does not disclose secretion products in the acini lumen that are
“products of activity of the cells” forming the membrane, we disagree for the
reasons already discussed: Debnath disclose a structure substantially similar
to the claimed structure, and further teaches that “the lumens of mammary
acini in vivo often contain proteinaceous secretory material” and that, at
least in some cases, mammary epithelial cells grown in three dimensions
produces milk proteins. (FF5, FF6.) In sum, the Examiner has
demonstrated “sound basis for believing that the products of the applicant
and the prior art are the same,” and Appellants have not met the burden of
showing that they are not. In re Spada, 91 F.2d at 708.
Claims 33 and 34
We find Appellants to have the better argument for claims 33 and 34,
for the same reason as discussed above with respect to Zetter.
Accordingly, we affirm the Examiner’s rejection of claim 1 as
anticipated by Debnath but reverse the rejection of claims 33 and 34 on this
ground. Claims 2, 4, and 7, which were not separately argued, fall with
claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
41
Appeal 2015-007398
Application 12/726,158
Issue
VI.
The Examiner rejects claims 1, 2, 4, 7, and 33—36 under pre-AIA
35 U.S.C. § 102(b) as anticipated by or, in the alternative, under pre-AIA
35 U.S.C. § 103(a) as obvious over, Kirk, as evidenced by Volvox Study
Guide. The Examiner finds that
Kirk teaches volvox is a spherical multicellular green
alga containing many small biflagellate somatic cells and non-
motile gonidia, and moves by a rolling motion. The volvox
spheroid contains within its core extracellular matrix and
juvenile spheroids. [As evidenced by the Volvox Study Guide,]
[t]he volvox spheroid is 350-500 microns in size. Thus, the
volvox spheroid is composed of volvox cells that form a
membrane surrounding a gel center that contains cells as well as
secreted volvox proteins, the extracellular matrix. Volvox
meets the limitations of the claims. No distinction [exists]
between the Volvox taught by Kirk and the claimed invention.
Thus, Kirk anticipates or makes obvious the claimed invention.
(Ans. 14—15 (citations omitted).)
Appellants contend that Kirk does not teach “a ‘membrane’ of volvox
cells formed to create a reservoir as specified for claim[] 32.”24 (Appeal Br.
58.) With respect to claims 33 and 34, Appellants argue that Kirk does not
disclose a membrane made of components of a cell. {Id. at 59.) With
respect to claims 35 and 36, Appellants further argue that Kirk does not
disclose a volvox algae or algae micro-colony within any reservoir formed
by a membrane. (Id.) In the Reply Brief, Appellants further argue that Kirk
does not disclose “a membrane formed of cells in machinery in a particular
24 The Examiner does not appear to have rejected claim 32 over Kirk. We
thus understand Appellants to be referring to claim 1 in this statement.
42
Appeal 2015-007398
Application 12/726,158
manner and that once formed are an isolated, independent unit,” as required
by claim 1. (Reply Br. 41.)
Appellants do not separately argue claims 2, 4, and 7. We therefore
limit our analysis to claims 1 and 33—36. The issue with respect to this
rejection is whether the evidence of record supports the Examiner’s
conclusion that claims 1 and 33—36 are anticipated or rendered obvious by
Kirk.
Analysis
Claim 1
We find that the Examiner has established a prima facie case of
anticipation of claim 1 in view of Kirk. Kirk teaches that volvox is a
spherical multicellular algae that contains many small somatic cells and a
few large non-motile reproductive cells. (FF9.) Kirk teaches that following
asexual reproduction adult volvox comprises an outer layer of cells
surrounding an enclosed volume containing juvenile volvox spheroids and
glycoprotein-based extracellular matrix deposited by the volvox. (FF10-
12.) Accordingly, Kirk teaches the volvox as comprising cells assembled in
three dimensions and organized to form a membrane, with the membrane
configured to define an enclosed volume. Furthermore, the volvox is an
independent unit and an isolated product within the broadest reasonable
interpretation of those terms. (FF12 (figure depicting a spheroid of Volvox
carteri); see also FF9-FF11.) Finally, Kirk discloses that the enclosed
volume contains a product of the activity of the membrane of cells, namely
the glycoprotein-based extracellular matrix. (FF11.)
Appellants contend that Kirk teaches composition of volvox cells, not
“a ‘membrane’ of volvox cells formed to create a reservoir as specified for
43
Appeal 2015-007398
Application 12/726,158
claim[] 32.”25 (Appeal Br. 58.) In particular, Appellants contend that
“applicants’ membrane (outer shell) must be made of more than one cell,
not simply confine other cells within the outer shell,” and “Kirk has no
teaching that the outer structure of the volvox cell is multi-cellular.” (Id.)
Applicants’ apparent argument is that Kirk discloses the volvox as a single
cell containing many somatic cells and a few larger reproductive cells. (Id.)
We are unpersuaded by this strained reading of Kirk’s disclosure, which also
contradicts Appellants’ own description of the volvox in the Specification:
Volvox algae, or simply volvox, is one of the best-known
chlorophytes and is the most developed in a series of genera
that form spherical colonies. Each mature volvox colony is
composed of numerous flagellate cells..., up to 50,000 in
total, and embedded in the surface of a hollow sphere or
coenobium containing an extracellular matrix made of a
gelatinous glycoprotein.
(Spec. 1143.)
In the Reply Brief, Appellants argue for the first time that Kirk does
not disclose “a membrane formed of cells in machinery in a particular
manner and that once formed are an isolated, independent unit,” as required
by claim 1. (Reply Br. 41.) Appellants have waived this argument since it
was not presented for the first time in the opening Appeal Brief. Ex
parte Borden, 93 USPQ2d 1473, 1473—74 (BPAI 2010) (“informative”26)
(absent a showing of good cause, the Board is not required to address an
argument newly presented in the reply brief that could have been presented
in the principal brief on appeal). In any event, as already discussed, a
25 The Examiner does not appear to have rejected claim 32 over Kirk. We
thus understand Appellants to be referring to claim 1 in this statement.
26 Designated as an “Informative Opinion” at
http: // www.uspto. gov/ ip/boards/hpai/decisio ns/ inform/index .j sp.
44
Appeal 2015-007398
Application 12/726,158
volvox is an isolated, independent unit, and furthermore “[t]he patentability
of a product does not depend on its method of production.” In re Thorpe,
111 F.2d at 697.
Claims 33 and 34
We find Appellants to have the better argument for claims 33 and 34,
for the same reason as discussed above with respect to Zetter.
Claim 35
With respect to claim 35, Appellants argue that Kirk does not disclose
a volvox algae within any reservoir formed by a membrane. (Appeal Br.
59.) We are not convinced. Claim 35 recites an artificial gland comprising
“cells assembled in three dimensions and organized to form a membrane . . .
defining an enclosed micro-scale volume,” where “[the] reservoir within the
enclosed micro-scale volume . . . comprise^] volvox algae.” {Id. at 98
(Claims App’x).) Kirk discloses that, following asexual reproduction, the
juvenile volvox spheroids are contained within the adult spheroid until they
“digest their way out of the parental matrix and become free-swimming.”
(FF11.) Thus, Kirk discloses volvox algae (i.e., the junior volvox spheroids)
within a reservoir formed by a membrane of the adult volvox, which is in
turn formed of multiple cells as discussed above.
Claim 36
With respect to claim 36, Appellants further argue that Kirk does not
disclose a claimed algae micro-colony within any reservoir formed by a
membrane. (Appeal Br. 59.) We find Appellants have the better argument.
Claim 36 requires an artificial gland comprising “cells assembled in three
dimensions and organized to form a membrane . . . defining an enclosed
micro-scale volume,” where “[the] reservoir within the enclosed micro-scale
45
Appeal 2015-007398
Application 12/726,158
volume . . . comprise[s] an organized algae micro-colony selected from the
group consisting of diatoms, cyanobacteria, pediastrum, hydrodictyon,
chlorella, paramecium bursania, Haematococcus pluvialis, spirogyra,
mougeotia and zygnema.” (Id. at 98—99 (Claims App’x).) The Examiner
has not explained how Kirk discloses or renders obvious a reservoir
comprising an algae micro-colony selected from the recited species.
Accordingly, we affirm the Examiner’s rejection of claims 1 and 35 as
anticipated by Kirk, but reverse the rejection of claims 33, 34, and 36 on this
ground. Claims 2, 4, and 7, which were not separately argued, fall with
claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
VI.
Issue
The Examiner rejects claims 1, 2, 4, 5, and 33—36 under pre-AIA
35 U.S.C. § 102(b) as anticipated by or, in the alternative, under pre-AIA
35 U.S.C. § 103(a) as obvious over, Napolitano. The Examiner finds that
“Napolitano teaches a hydrogel core surround[ed] by fibroblast cells or
fibroblast and endothelial cells .... Hydrogel is a nanoparticle[;] thus, the
reservoir comprises nanoparticles. Thus, Napolitano clearly anticipates the
claimed invention.” (Ans. 15 (citations omitted).)
Appellants contend that Napolitano teaches “[a] spheroid of cells
formed in the bottom of recesses of a gel,” which Appellants argue is “a
completely different structure than cells ‘organized to form a membrane . . .
to define an enclosed volume,’ as specified in applicants’ claim 1.” (Appeal
Br. 61.) Appellants also argue that Napolitano does not disclose the
spheroid containing “a product of activity of the cells forming that
spheroid.” (Id.) Appellants argue that the Examiner’s finding of
46
Appeal 2015-007398
Application 12/726,158
anticipation with respect to Napolitano fails to cite all of the limitations of
claims 1, 2, 4, and 5. (Id.) With respect to claims 33 and 34, Appellants
argue that Napolitano does not disclose “a membrane assembled from
‘components of a cell.’” (Id. at 62.) With respect to claims 35 and 36,
Appellants argue that Napolitano does not disclose a volvox algae or an
algae micro-colony within the alleged reservoir. (Id.)
The issue with respect to this rejection is whether the evidence of
record supports the Examiner’s conclusion that Napolitano anticipates or
renders obvious claims 1, 2, 4, 5, and 33—36.
Analysis
We find Appellants to have the better argument. The Examiner
argues that Napolitano anticipates and/or render obvious the claims because
it teaches “a hydrogel core surround by fibroblast cells or fibroblast and
endothelial cells.” (Ans. 15 (citations omitted).)
As Appellants point out, however, Napolitano teaches self-assembled
cellular aggregates that form, e.g., spheroids in the bottom of the recess of a
gel. (Appeal Br. 61; see, e.g., Napolitano Abstract; 2089, left column; Figs.
1 and 2.) The Examiner has not explained how such spheroids would
contain a hydrogel core given that they form in a recess of the gel.
In response to Appellants’ argument, the Examiner argues that “there
is no evidence in Napolitano that the spheres did not enclose a defined
volume” and that “Napolitano teaches in the 200 pm wells expansion [of the
cell aggregate] in the horizontal dimension was physically constrained by
the hydrogel.” (Ans. 42 (citations omitted).) We are not persuaded. First,
Napolitano describes spheroids containing, for instance, a normal human
fibroblast (NHF) core coated with human umbilical vein endothelial cells
47
Appeal 2015-007398
Application 12/726,158
(HUVECs). (Napolitano Abstract.) Thus, it is not clear that Napolitano
discloses a “membrane” of cells that defines an “enclosed volume,” much
less a hydrogel core, rather than a solid spheroid of cells. In addition, given
that Napolitano’s spheroid cell aggregates are formed in the hydrogel well, it
is unsurprising that they are constrained by the well size. The Examiner has
not explained, however, how such constraint suggests that the spheroid
contains a hydrogel core.
With respect to claims 33—36, we further agree with Appellants that
the Examiner has not shown how Napolitano disclose “components of a cell
assembled in three dimensions and organized to form a membrane,” as
required by claims 33 and 34, or a reservoir within an enclosed volume
comprising volvox algae or an organized algae micro-colony, as required
respectively by claims 35 and 36. Neither has the Examiner provided a
response to Appellants’ arguments with respect to these claims.
Accordingly, we reverse the Examiner’s rejection of claims 1, 2, 4, 5,
and 33—36 as anticipated by Napolitano. Because the Examiner has not
articulated any separate rationale why the above-discussed claim limitations
are rendered obvious by Napolitano, we also reverse the Examiner’s
rejection of claims 1, 2, 4, 5, and 33—36 as obvious over Napolitano.
SUMMARY
With respect to the rejection under 35 U.S.C. § 101, we affirm the
rejection of claims 1—4, 7, and 35 and reverse the rejection of claims 33, 34,
and 36.
With respect to the rejection under 35 U.S.C. § 112(a) or 35 U.S.C.
§112 (pre-AIA), first paragraph, for failure to comply with the written
48
Appeal 2015-007398
Application 12/726,158
description requirement, we affirm the Examiner’s rejection of claims 1—5,
7, 8, and 13.
With respect to the rejection under 35 U.S.C. § 112(a) or 35 U.S.C.
§112 (pre-AIA), first paragraph, for failure to comply with the enablement
requirement, we affirm the Examiner’s rejection of claims 1—5, 7, 8, 13, and
31-36.
With respect to the rejection under pre-AIA 35 U.S.C. § 102(b) as
anticipated by or, in the alternative, under pre-AIA 35 U.S.C. § 103(a) as
obvious over, Zetter, we affirm the Examiner’s rejection of claims 1, 2, 4,
and 7 and reverse the Examiner’s rejection of claims 33 and 34.
With respect to the rejection under pre-AIA 35 U.S.C. § 102(b) as
anticipated by or, in the alternative, under pre-AIA 35 U.S.C. § 103(a) as
obvious over, Debnath, we affirm the Examiner’s rejection of claims 1, 2, 4,
and 7 and reverse the Examiner’s rejection of claims 33 and 34.
With respect to the rejection under pre-AIA 35 U.S.C. § 102(b) as
anticipated by or, in the alternative, under pre-AIA 35 U.S.C. § 103(a) as
obvious over, Kirk, we affirm the Examiner’s rejection of claims 1, 2, 4, 7,
and 35 and reverse the Examiner’s rejection of claims 33, 34, and 36.
We reverse the Examiner’s rejection of claims 1, 2, 4, 5, and 33—36
under pre-AIA 35 U.S.C. § 102(b) as anticipated by or, in the alternative,
under pre-AIA 35 U.S.C. § 103(a) as obvious over, Napolitano.
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
49