Ex Parte Marquez et al

Patent Trial and Appeal Board

Mar 27, 2017

12860867 (P.T.A.B. Mar. 27, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/860,867 08/21/2010 Manuel Marquez marquez867 1911
24221 7590 03/29/2017
LOUIS VENTRE, JR
2483 OAKTON HILLS DRIVE
OAKTON, VA 22124-1530
EXAMINER
WILSON, MICHAEL C
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
03/29/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
lventre @ lventre. com
ventre, louis @ verizon. net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MANUEL MARQUEZ and
SAMANTHA M. MARQUEZ1
Appeal 2015-005900
Application 12/860,867
Technology Center 1600
Before JEFFREY N. FREDMAN, TAWEN CHANG, and RYAN H. FLAX,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of making an artificial gland by taxis, which have been rejected as
non-enabled. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
According to the Specification, “[t]he fabrication of artificial micro­
glands needs to be made simpler, easier, faster, and readily reproducible to
accommodate their wide-spread use in the healing arts in the biomedical or
1 Appellants identify the Real Party in Interest as the inventors Manuel
Marquez and Samantha Marquez. (Appeal Br. 3.)
Appeal 2015-005900
Application 12/860,867
biotechnological fields,” and “[improvements are needed in enabling full
control of the shell/reservoir structure of the artificial micro-gland.” (Spec.
110.) Further according to the Specification, “[a]rtificial micro-glands can
be made simply and more easily by using a monodisperse multiple emulsion
as templates having distinct fluids with one or more interfaces between the
fluids in the emulsion,” where “[t]he cells placed in one fluid migrate on
their own to the interface to assemble and surround an inner fluid and form
the artificial micro-gland.” {Id. at Tf 11.) In particular, the Specification
purports to describe “methods of making an artificial micro-gland ... by
taxis.” {Id. at 122.)
Claims 1—10 are on appeal. Claim 1 is illustrative and reproduced
below:
Claim 1. A method of making an artificial micro-gland by taxis, the
artificial micro-gland comprising a continuous membrane of living
cells, the continuous membrane defining an enclosed volume, the
enclosed volume comprising a reservoir serving as a bioreactor, the
method comprising the steps of:
producing a monodisperse multiple emulsion, the monodisperse
multiple emulsion comprising:
a first fluid serving as a host environment;
a second fluid confined within the host environment, the
second fluid being immiscible in the first fluid;
a third fluid within the second fluid, the third fluid being
immiscible in the second fluid such that there is an
interface between the second fluid and the third fluid, the
third fluid comprising a plurality of living cells dispersed
therein, said living cells capable of metabolic activity;
and,
an agent capable of affecting the metabolic activity of the
living cells, the agent present within the second fluid at a
higher concentration than in the third fluid;
2
Appeal 2015-005900
Application 12/860,867
waiting until the living cells migrate to the interface between the
second fluid and the third fluid to form the continuous
membrane around the third fluid; and,
removing the first fluid and the second fluid from the
monodisperse multiple emulsion to produce the artificial micro­
gland.
(Appeal Br. 5—6 (citations omitted).)
The Examiner rejects claims 1—10 under 35 U.S.C. § 112(a) or
35 U.S.C. § 112 (pre-AlA), first paragraph, as failing to comply with the
enablement requirement. (Ans. 2.)
DISCUSSION
Issue
The Examiner finds that “it is clear the specification discloses the
methods claimed to be for the production of an artificial gland by taxis, and
the gland is to be used as an in vivo or in situ drug delivery system or as a
treatment for tissue or organ repair.” (Ans. 3—4.) The Examiner further
finds that “[a] gland is an organ or a tissue that produces and secretes
proteins, enzymes or hormones in order to establish and maintain
homeostasis,” where “[t]he gland secretes the proteins either constitutively
or regulated by a signal from outside of the gland.” {Id. at 8.) Based on the
above, the Examiner finds that the Specification “lacks sufficient guidance
to make an artificial gland that exhibits a patentable use” at the time of the
invention, because “the structure [recited in the claims] is not a gland in the
meaning of the art” and “lacks an enabled use as a drug delivery vehicle” or
“for organ or tissue regeneration.” {Id. at 3, 9—10.)
3
Appeal 2015-005900
Application 12/860,867
More specifically, the Examiner finds that “[t]he claims state
‘methods of making an artificial micro-gland by taxis[,]’ but. . . neither the
claims nor the specification teach the methodology required for taxis to
make the gland.” (Id. at 5—6.) The Examiner also finds that the
Specification discloses producing the artificial gland using pathogens such
as bacterial or yeast cells, which the Examiner finds to lack patentable use in
light of the disease-causing nature of the pathogens. (Id. at 8—9.) The
Examiner further finds that the Specification fails to enable use of the
artificial gland made by the claimed method, because the Specification “does
not offer any guidance for overcoming an immune system response to an
implanted artificial micro[-]gland.” (Id. at 8.) Likewise, the Examiner finds
that the structure made according to the claimed methods are not enabled for
use as an artificial gland or a pharmaceutical delivery device, because the
structure “lacks the mechanism for either constitutive release or regulated
release” of proteins, enzymes, or hormones. (Id. at 8—9.) Finally, the
Examiner finds that the Specification does not enable an artificial gland
where the claimed “reservoir” is a gas, because the Specification “provides
no guidance as to the type of gas that would solubilize proteins, enzymes or
hormones.” (Id. at 9.)
Appellants argue that the claims are to a method of making an
artificial gland and not to the structure, and take issue with the Examiner’s
interpretation of “gland.” (Appeal Br. 38-41.) Appellants also contend that
the Examiner’s arguments are based on the erroneous premise that the
artificial micro-gland recited in the claims must be enabled for in vivo use.
(Id. at 41—42; Reply Br. 19—25.) Appellants further cite to the Cheng
4
Appeal 2015-005900
Application 12/860,867
Declaration2 and various news articles in support of the “operability,
functionality and usefulness of the claimed artificial gland.” (Appeal Br. 23
(internal quotation marks and citation omitted).)
With respect to the Examiner’s finding that the Specification and the
claims do not teach the methodology required for taxis to make the gland,
Appellants argue that the claims recite both a taxis agent and how to form a
gradient of attractant through the use of multiple emulsions. {Id. at 25—26,
28—32; see also Reply Br. 25—26.) Appellants further argue that the
Specification provides sufficient guidance for enablement by teaching
various types of taxis such as the taxis of bacteria towards a higher
concentration of oxygen and how to form a gradient of attractant so as to
induce taxis. (Appeal Br. 27—28, 32—35.)
Appellants do not separately argue the claims {id. at 19), 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 claim 1 is
invalid for failure to comply with the enablement requirement.
Findings of Fact
1. The Specification states:
The artificial micro-gland has a shell of living cells surrounding
a core or reservoir. The term “living cells” is intended to
broadly encompass biological units and cells .... The more
significant applications of the invention are currently expected
to employ living cells comprising fungi, algae, fibroblasts, yeast
and bacteria. The reservoir is a micro-volume bio-reactor that
2 Declaration of Zhengdong Cheng under 37 C.F.R. § 1.132 (Oct. 25, 2012)
(“Cheng Decl.”). The Cheng Declaration is not paginated. Therefore, all
reference to page numbers in the Cheng Declaration refer to page numbers
as if the Cheng Declaration was numbered consecutively beginning with the
first page.
5
Appeal 2015-005900
Application 12/860,867
supports a biologically active environment. For example, it
may host a medicinal component or biological activity creating
helpful substances for promoting healing, vaccination, or food
active ingredients.
(Spec. 13.)
2. The Specification states that “the reservoir of the artificial
micro-gland . . . may comprise oil, water, oil and water emulsion, or any
other combination of liquids, gases and cells serving the bioreactor function
of the reservoir.” (Id. at | 52; see also, e.g., id. at || 17 (water reservoir), 18
(oil reservoir), 19 (oil-within-water reservoir), 70 (defining fluid to include
liquid or gas, and explaining that “exemplary fluids of water or oil, may also
include or contain nutrients or other additives compatible with the living
cells”).)
3. According to the Specification, “[t]he method disclosed herein
for making the micro-glands stimulates micro-gland shell growth through
taxis, that is, a form of tropism, involving the stimulating the motility or
migration of a cell or organism towards or away from a location to form a
shell usually at a liquid/liquid interface.” (Id. at If 4.) The Specification
states that chemicals used for chemotaxis
affect metabolic activity of the living cells and so their presence
in higher concentrations in an adjoining or surrounding
emulsion selectively draws the cells to the interface of the
emulsions. Thus, upon creation of at least one emulsion
containing the living cells, wherein that emulsion is confined
within at least one other emulsion having a higher concentration
of a chemoattractant useful to the living cells metabolism, taxis
enables movement of the living cells to the interface where they
form a continuous membrane surrounding the emulsion
previously containing the living cells.
(Id. at 17.)
6
Appeal 2015-005900
Application 12/860,867
4. The Specification provides bacteria and oxygen and algae and
carbon dioxide as example combinations of cells and chemo-attractants that
may be used in the claimed method of making an artificial micro-gland by
taxis. (Id. at H 6, 26, 32, 38, 39, 46, 58, 60, 65.)
5. The Specification states that, “[w]hile the . . . examples . . .
utilize bacteria and algae for the living cells . . ., there are many other such
living cells . . . , which may be used and which are drawn from the panoply
of eukaryotic cells and prokaryotic cells. (Id. at H 33, 40, 48; see also id. at
11 56, 64.)
6. The Specification further states that other agents that may be
used to cause chemotaxis include
nitrogen oxide; sugar; phosphates, nitrates, sulphates, and
potassium salts; cyclic adenosine monophosphate (cAMP);
inositon phospholipid (mPIP3); actin; histamine; serotonin
(5HT); plaletet [sic] acting factors (PAF); arachidonic acid
metabolites; diacykglyseril (IP3); leukotine B4; lipoxins;
prostaglandins; cytotaxin; f-met-leu-phe tripeptide; cytokines;
kinins, cytotaxins; anaphylatoxin peptide (C5a); aspartic acid
(ASP); serine (SER); and, chemo-attractants.
(Id. at 1134, 41, 48.)
7. The Specification does not provide any working examples.3
8. The Specification states that “the artificial gland is useful for
biological tissue and organ repair and replacement and stem cell engineering
and biotechnology application.” (Id. at 12; see also id. at H 12 (stating that
3 In Example 1, the Specification states that “[e]xamples of bacteria actually
used are pseudomonas aeruginosa, b. subtilis and p. aeruginos.” (Spec. 129
(emphasis added).) Because the remainder of Example 1 are described in
present tense; we nevertheless understand Example 1 to be a prophetic,
rather than working, example.
7
Appeal 2015-005900
Application 12/860,867
claimed method “will promote greater use of artificial micro-glands to
improve tissue and organ repair, and the delivery of treatments incident to
healing and recovery from cellular injuries” and “enables greater control of
the shell/reservoir structure of the artificial micro-gland”), 72 (stating that
“[t]he invention has application to the biomedical and biotechnological
industries”).) The Specification also states that “[t]he micro-gland has
potential application as a means for drug and/or cell delivery within human
or other animal.” (Id. at 13.)
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).
8
Appeal 2015-005900
Application 12/860,867
Courts “have required a claimed invention to have a specific and substantial
utility to satisfy § 101.” Id. at 1371.
[A]n application must show that an invention is useful to the
public as disclosed in its current form, not that it may prove
useful at some future date after further research. Simply put, to
satisfy the “substantial” utility requirement, an asserted use
must show that th[e] claimed invention has a significant and
presently available benefit to the public.
Id.
To satisfy “the ‘specific’ utility requirement, an application must
disclose a use which is not so vague as to be meaningless. . . . Thus, in
addition to providing a ‘substantial’ utility, an asserted use must also show
that th[e] claimed invention can be used to provide a well-defined and
particular benefit to the public.” 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). “ft is an
applicant’s obligation to supply enabling disclosure without reliance on what
others may publish after he has filed an application on what is supposed to
be a completed invention. If he cannot supply enabling information, he is
not yet in a position to file.” In re Glass, 492 F.2d 1228, 1232 (CCPA
1974).
Analysis
We agree with the Examiner that claim 1 fails to satisfy the
enablement requirement because the Specification does not enable the full
9
Appeal 2015-005900
Application 12/860,867
scope of the claim with respect to the method of making an artificial micro­
gland by taxis. In considering the Wands factors, we first note that claim 1
is extremely broad. For instance, it encompasses methods of making an
artificial micro-gland comprising a continuous membrane of any of the
“panoply of eukaryotic cells and prokaryotic cells” as well as “biological
units.” (FF1 (“The term ‘living cells’ is intended to broadly encompass
biological units and cells.”).) Likewise, it encompasses broad categories of
taxis, including for instance chemotaxis with agents ranging from the gas
nitrogen oxide to the amino acid serine. (FF6.) The Specification, however,
contains no working examples (FF7), and includes minimal guidance on the
combination of taxis agents and cells or biological units that would result in
the claimed artificial micro-gland. (FF4 (providing only bacteria and
oxygen and algae and carbon dioxide as example combinations of cells and
chemo-attractants that may be used in the claimed methods).) While the
Specification points to prior art teaching methods of creating multiple
emulsions (Spec. | 5), neither the Examiner nor Appellants have pointed to
prior art relating to creation of a continuous membrane through taxis.
Finally, given the shortage of guidance in the Specification and the
unpredictability of biological processes, we find that enabling the full scope
of claim 1 would likely involve a significant amount experimentation. Cf In
re Angstadt, 537 F.2d 498, 508 (CCPA 1976) (“In cases
involving unpredictable factors, such as most chemical reactions and
physiological activity, the scope of enablement obviously varies inversely
with the degree of unpredictability of the factors involved.”).
We also agree with the Examiner that the Specification has not
enabled a use for the method of claim 1. In particular, Appellants’ broad
10
Appeal 2015-005900
Application 12/860,867
statements regarding potential use of the artificial micro-gland made by the
claimed method (FF1, FF8) do not describe the “specific and substantial”
utility needed to satisfy the enablement requirement. Generic statements
that the artificial gland is useful for “biological tissue and organ repair and
replacement,” “stem cell engineering,” “biotechnology application,” and
“drug and/or cell delivery” are too vague to provide specific utility. In re
Fisher, 421 F.3d at 1371. Similarly, these statements do not provide
substantial utility because they suggest that the artificial gland “may prove
useful at some future date after further research,” but do not show that it is
“useful to the public as disclosed in its current form.” Id. The Specification
states, for example, that “[t]he more significant applications of the invention
are currently expected to employ living cells comprising fungi, algae,
fibroblasts, yeast and bacteria” (FF1 (emphasis added), and that “[t]he
micro-gland has potential application as a means for drug and/or cell
delivery within human or other animal” (FF8 (emphasis added)).
In this respect, we also note that, while working examples are not
necessary to satisfy enablement, they are desirable in complex technologies,
and the Specification provides no such examples of using the artificial gland
manufactured by the claimed method. In re Strahilevitz, 668 F.2d 1229,
1232 (CCPA 1982) (working examples desirable but not necessary); In re
Fisher, 421 F.3d at 1377 (finding lack of specific and substantial utility
because “[applicant’s] laundry list of uses, like the terms ‘biological activity’
or ‘biological properties’ alleged in Kirk, are nebulous, especially in the
absence of any data demonstrating that the claimed [inventions] were
actually put to the alleged uses”).
11
Appeal 2015-005900
Application 12/860,867
Appellants argue that the Specification enables the claimed method of
making the gland by taxis because the claims recite both a taxis agent and
multiple emulsions where an emulsion contains an attractant at a higher
concentration forming an interface with another emulsion, i.e., “an agent
capable of affecting the metabolic activity of. . . living cells” where “the
agent [is] present within [a] second fluid at a higher concentration than in [a]
third fluid.” {Id. at 25—26, 28—32; see also Reply Br. 25—26.) Appellants
further argue that the Specification teaches various types of taxis that may be
used in the claimed artificial gland, including, e.g., the taxis of bacteria
towards a higher concentration of oxygen, as well as guidance on how to
form a gradient of attractant so as to induce taxis. (Appeal Br. 27—28, 32—
35.)
We are not persuaded. As discussed above, while the Specification
provides two exemplary combinations of cells and chemo-attractants that
may be used in the claimed method (bacteria/oxygen and algae/carbon
dioxide), the disclosure is not commensurate with the broad scope of the
claim. The Specification neither suggests that all of the many agents alleged
to affect metabolic activity would lead to the taxis of all of the claimed types
of “living cells” so as to create the structure recited in the claims, nor
provides sufficient guidance for determining, for instance, which
combinations of the many cell types and taxis agents encompassed by the
claims would result in the “artificial micro-gland.”
With respect to the Examiner’s argument that the Specification does
not enable a use of the artificial micro-gland recited in the claims,
Appellants first argue that the claims are to a method of making an artificial
gland and not to the structure. (Appeal Br. 38.) This argument is not
12
Appeal 2015-005900
Application 12/860,867
convincing. While we agree that the claims are to a method of making an
artificial micro-gland and not to the micro-gland themselves, Appellants do
not articulate how this distinction renders the Examiner’s analysis erroneous.
Cf. Brenner v. Manson, 383 U.S. 519, 534—535 (1966) (holding that a
process lacks utility if the produced product lacks utility).
Appellants next argue that the enablement rejection is based on an
incorrect construction of the limitation “artificial micro-gland.” (App. Br.
38-41.) In particular, Appellants contend that, in the context of the claims,
an artificial micro-gland simply refers to “a cellular structure surrounding a
reservoir that is a bio-reactor holding for example a medicinal component.”
Appellants further argue that, while the “common definition of the term
gland encompasses the artificial micro-gland made by the method of the
invention,” the claim terms “artificial” and “micro” also “possibly
distinguish [the claimed artificial micro-gland] from the natural gland” on
which the Examiner bases her construction of the claim. Id.
We are likewise unpersuaded by these arguments. Even assuming
Appellants’ construction of “artificial micro-gland” to be correct, the
Specification has not disclosed a specific and substantial utility for such a
structure for the reasons discussed earlier and reiterated below.
Appellants argue that the Examiner’s enablement rejection is based on
the erroneous premise that the artificial micro-gland recited in the claims
must be enabled for in vivo use. (Appeal Br. 41—42; Reply Br. 19—25.)
Appellants contend that, although “z7? vivo applications in limited
circumstances might be conceivable,” “nothing in the claims or in the
specification . . . requires in vivo or in situ drug delivery.” (Appeal Br. 21,
23; see also id. at 36—37.) Appellants cite to a portion of the Specification
13
Appeal 2015-005900
Application 12/860,867
stating that “the artificial gland is useful for biological tissue and organ
repair and replacement and stem cell engineering and biotechnology
applications” and contend that “[a]ny person of skill in the art would know
that stem cell engineering and biotechnology applications are not necessarily
in vivo research fields.” (Reply Br. 23.) Citing a 2014 news article as well
as a Wikipedia article regarding experimentation with organs-on-chips,
Appellants argue that “it is well known that organs and tissue can be made
and repaired outside the body.” (Appeal Br. 22; Reply Br. 20-21.)
We are not convinced. As discussed above, regardless of whether
stem cell engineering, biotechnology applications, and biological tissue and
organ repair and replacement encompass in vitro as well as in vivo
applications, a generic statement that the artificial gland recited in the claims
is useful for these purposes does not disclose a specific and substantial use
necessary for enablement: Such generalized description of the fields in
which invention may be useful is too vague to constitute specific use, and
the lack of information regarding how the artificial gland may be used in
these fields indicates that the Specification has at most suggested that the
artificial micro-gland “may prove useful at some future date after further
research,” which does not suffice to show substantial use. In re Fisher, 421
F.3d at 1371. Indeed, Smith,4 the CNN news article Appellants cite as
suggesting that organs and tissues may be repaired in vitro, supports a
finding of lack of enablement: Although Smith is dated April 2014, over
three and half years after the filing date of the instant application, the article
4 Stephanie Smith, Creating body parts in a lab: ‘Things are happening
now’, CNN (April 10, 2014), available at
http://www.cnn.com/2014/04/10/health/tissue-engineering-success/ (last
visited Mar. 6, 2017) (“Smith”).
14
Appeal 2015-005900
Application 12/860,867
described growing reproductive organs and nasal cartilage in labs and
successfully implanting them as a “scientific leap,” and further states that
‘“[t]issue engineering is finally demonstrating that it can deliver on
expectations.’”
Finally, Appellants’ citation to the Cheng Declaration and news
articles showing “[o]ne of the inventors . . . receiving] acclaim in the field
for her invention” is unavailing. (Appeal Br. 22—23.) The news articles
allege a broad range of potential uses for “celloidosomes,” which Appellants
contend to be the artificial micro-gland recited in the claims. None of them,
however, suggests that the Specification enables such uses because none of
them suggests that the celloidosome is useful for such applications in its
current form, without further research.
With respect to the Cheng Declaration, we note first that expert
opinions on ultimate legal issues, such as statements in the Cheng
Declaration that “the methods of making the artificial gland [is] fully
descriptive and readily followed without the necessity for experimentation,”
that “peer[] reviewed scientific reports on the manufacture and use of the
artificial gland [support] the operability, functionality and usefulness of the
claimed artificial gland,” and that “the claimed artificial gland [is] a unique
innovation that is described in sufficient detail to be operable and to enable it
to be made and used without undue experimentation” (Cheng Decl. 2, 4), are
not entitled to weight absent supporting evidence. In re Reuter, 670 F.2d
1015, 1023 (CCPA 1981). Furthermore, while Dr. Cheng states that there is
“experimental evidence that Fungi, Algae, Bacteria and also a diverse group
of mammalian Cells (NIH-3T3, Cortical Cells, HEP-G2, etc.) can be ‘self-
assembled’ in liquid-liquid interfaces from multiple emulsions” and that
15
Appeal 2015-005900
Application 12/860,867
“those cells can be self-assembled on gas- liquid interfaces of microbubbles,
to form stable micro-core/shell tissues as described by Marquez, et al in their
patent application,” Dr. Cheng provides no analysis showing that the cited
references in fact manufactured such “micro-core/shell tissues” by the
claimed method of taxis, much less that they provided enablement
commensurate with the broad scope of the claims. (Cheng Decl. 2.) Indeed,
it is unclear whether the statements in the Cheng Declaration refer to the
instant patent application at all, as Dr. Cheng refers to paragraphs 77 and
277 of the patent application, which do not exist in the instant Specification.
{Id.) Finally, all but one of the references cited by Dr. Cheng as supporting
the “operability, functionality and usefulness of the claimed artificial gland”
are dated after the date of the patent application, and there is no evidence
that they represent the state of the art at the time the patent application was
filed.5 (Cheng Decl. 2-3.)
5 The only cited reference that predates the date of the application, Aug. 21,
2010, is a presentation at NANOSPAIN 2010. Manuel Marquez et al., A
New Paradigm for Cell Architecture: Celloidosomes®, NANOSPAIN 2010
(March 23, 2010), available at
http://www.nanospainconf.org/2010/Posters/NanoSpain2010_Marquez.pdf.
Dr. Cheng, however, fails to explain how the methods described in the
presentation to “drive & organize living cells (yeast, fibroblasts, etc.) to the
surface of a Gel, Liquid or Gas (Bubble),” e.g., “LbL polyelectrolyte
decoration,. . . selective gelation using CaC03 nanoparticles-Cells
composites, [and] Hydrophobic deposition,” meet the limitations of the
claimed methods. {Id.) If anything, the presentation supports the conclusion
that the claimed artificial gland does not have a specific and substantial use
at the time of the application, as the presentation “focus [es] on showing the
potential of [the] emerging and enabling technology.” {Id. (emphasis
added).)
16
Appeal 2015-005900
Application 12/860,867
Accordingly, we affirm the Examiner’s rejection of claim 1 under
35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing
to comply with the enablement requirement. Claims 2—10, which are not
separately argued, fall with claim 1.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
17