Ex Parte 7955614 et al

Patent Trial and Appeal Board

Aug 8, 2016

95002099 (P.T.A.B. Aug. 8, 2016)

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.
95/002,099 08/24/2012 7955614 091505-0022/8002.US 1171
108547 7590 08/09/2016
McDermott Will & Emery LLP
500 North Capitol Street NW
Washington, DC 20001
EXAMINER
KUNZ, GARY L
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
08/09/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

NANO PRECISION MEDICAL
Requester and Appellant

v.

DELPOR, INC.
Patent Owner and Respondent
____________

Appeal 2016-002917
Reexamination Control 95/002,099
Patent 7,955,614 B2
Technology Center 3900
____________

Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
RAE LYNN P. GUEST, Administrative Patent Judges.

Opinion for the Board filed by GUEST, Administrative Patent Judge.

Opinion Dissenting-in-part filed by FREDMAN, Administrative Patent
Judge.

DECISION ON APPEAL

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Third Party Requester, Nano Precision Medical (“Requester”),
appeals under 35 U.S.C. §§ 134(c) and 315(b) (pre-AIA) the Examiner’s
decision not to reject claims 1–6, 8–16, 19–22, and 30–38.1 Patent Owner,
Delpor, Inc. (“Patent Owner”), supports the Examiner confirmation of the
patentability of claims 1–6, 8–16, 19–22, and 30–38, as amended in the
present reexamination.2 We have jurisdiction under 35 U.S.C. §§ 134(c) and
315(b) (pre-AIA).
We heard oral arguments from Patent Owner on June 15, 2016, a
written transcript of which will be entered into the electronic record in due
course.
We AFFIRM-IN-PART, REVERSE-IN-PART, and enter a new
ground of rejection pursuant to our authority under 37 C.F.R. § 41.77(b).

STATEMENT OF THE CASE
United States Patent 7,955,614 B2 (hereinafter the “’614 Patent”),
which is the subject of the current inter partes reexamination, issued to
Francis J. Martin and Anthony A. Boiarski on June 7, 2011.

1 Claim 7 was not subject to reexamination, and claims 17, 18, and 23–29
have been cancelled during this reexamination proceeding. See Requester’s
Appeal Brief 5 (filed July 17, 2015) (hereinafter “Req. App. Br.”);
Requester’s Rebuttal Brief (filed November 23, 2015) (hereinafter “Req.
Reb. Br.”); and Examiner’s Answer (mailed October 23, 2015) (hereinafter
“Ans.”) incorporating the Right of Appeal Notice (mailed April 21, 2015)
(hereinafter “RAN.”).
2 See Patent Owner’s Respondent Brief (filed August 27, 2015) (“PO Res.
Br.”) and Patent Owner’s Rebuttal Brief (filed November 23, 2015) (“PO
Reb. Br.”).
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The ’614 Patent relates to drug delivery devices designed to be
implanted in the body and specifically to an implantable drug delivery
device that utilizes a nanopore membrane fabricated to include channels
having precise geometry for controlling the release of a therapeutic agent
into the body. Col. 1, ll. 19–24. According to the ’614 Patent,
The capsule includes a nanopore membrane consisting of
an array of parallel channels with precise dimensions typically
in the 4 to 100 nm range separating the internal reservoir from
the external medium. By precisely tailoring the pores of the
membrane to the molecular dimensions of the drug, such
nanopore membranes serve to control the diffusion kinetics of
the therapeutic agent from the reservoir at a molecular level.
Presumably, the rate of diffusion is related to the geometry of
the channels which physically constrain the random molecular
motion of drug solute molecules in at least one dimension.
Thus, the rate of diffusion is slowed and controlled at a nearly
constant level as a function of pore size and is less dependent
on the concentration gradient. The device is capable of zero-
order release of a therapeutic agent after implantation over
prolonged periods (weeks to months, or even years).
Controlling the dosage delivered to the patient over time is also
possible with the present invention.
Id., col. 2, ll. 45-61.
Claims 1 and 20 are illustrative of the appealed subject matter and
read as follows (with underlining showing added text relative to the original
patent claims and brackets showing deleted text relative to the original
claims):
1. A drug delivery device, comprising:
a capsule for implantation into the body, wherein said
capsule comprises a fluid impermeable wall defining a
reservoir, [for containing a substance] said wall comprising at
least one port;
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a drug contained in the reservoir in an amount to provide
therapy for a period of several weeks to about 6 months, the
drug having molecular dimensions; and
a nanopore membrane in communication with said port,
said membrane having pores with a pore size (i) between 2-100
nm and (ii) 1-5 times the molecular dimensions of the drug such
that the pores [dimensioned to] control the rate of diffusion of
said [substance] drug to achieve zero-order release of the drug
from said [capsule] reservoir for the period.

20. A method for delivering a therapeutic agent to the
body in a controlled manner, said method comprising:
(a) providing a device comprising
a capsule comprised of a fluid impermeable wall
that defines a reservoir [for containing a therapeutic
agent], said wall having at least one port,
a therapeutic agent contained in the reservoir in an
amount to provide therapy for a period of several weeks
to about 6 months, the therapeutic agent having
molecular dimensions [for allowing said therapeutic
agent to diffuse from said reservoir]; said capsule also
comprising
a nanopore membrane in communication with said
port, said membrane having pores with a pore size (i)
between 2-100 nm and (ii) 1-5 times the molecular
dimensions of the therapeutic agent such that the pores
[dimensioned to] control the rate of diffusion of said
therapeutic agent by providing release kinetics which
approach zero-order release of the therapeutic agent from
said at least one exit port for the period; and
(b) surgically implanting said device into the body,
whereby the release kinetics provide a substantially constant
therapeutic level of the therapeutic agent in the body for the
period.

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PO App. Br. 44 and 46–47, Claims App’x (paragraph breaks added to claim
20 for clarity).
Requester appeals the Examiner’s decision to withdraw proposed
anticipation rejections based on Keller,3 Desai,4 and Martin 20015 as
evidenced by Sigma Insulin Product Sheet.6 See PO App. Br. 5–6 (Grounds
1–4 and 35); RAN 6–8.
Requester also appeals the Examiner’s decision to withdraw proposed
obviousness rejection based on Keller, Desai, Martin 2001 further in view of
additional prior art. See PO App. Br. 5–6 (Grounds 6–9, 11, 12, 14–16, 18,
19, and 26–29); RAN 6–8.
Requester also appeals the Examiner’s withdrawal of the rejection of
claims 1–6, 8–16, 20–22, and 30–38 under 35 U.S.C. § 112, first paragraph,
for lacking adequate written description (Grounds 34 and 38) and the
rejection of claims 1–6, 10–22 and 30–38 under 35 U.S.C. § 112, first
paragraph, for lack of enablement (Ground 36). See PO App. Br. 5–6; RAN
8 and 21–26.

3 WO 95/24472, published September 14, 1995, naming Christopher G.
Keller, et al., as inventors (“Keller”).
4 Tejal A. Desai et al., “Characterization of micromachined silicon
membranes for immunoisolation and bioseparation applications,” J.
Membrane Sci., Vol. 159, pp. 221–231 (1999) (“Desai”).
5 Frank J. Martin et al., “Microfabricated Drug Delivery Systems: Concepts
to Improve Clinical Benefit,” Biomedical Microdevices, Vol. 3, No. 2, pp.
97–108 (2001) (“Martin 2001”).
6 Sigma-Aldrich, Product Information Sheet for Insulin from Bovine
Pancreas, CAS Number 11070–73–8, Product Numbers I5500, I6634, I1882,
and I4011 (February 2003).
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Requester also argues that the amendments impermissibly broadened
claim 1 under 35 U.S.C. § 314(a). PO App. Br. 36–37; See RAN 8 and 22
(Ground 35).

CLAIM INTERPRETATION
Claim 1
Claim 1 is directed to a drug delivery device. Requester argues that a
drug delivery device meeting all of the recited structural limitations of the
recited device is taught by the prior art, and that the limitations directed to
the drug contained in the device’s reservoir do not add patentable weight to
the device. Req. App. Br. 11–16; Req. Reb. Br. 2–9. Patent Owner argues
that the Examiner was correct in finding that the drug and the size
limitations of the drug relative to the membrane pores are structural aspects
of the invention and that the functional result of having a zero-order release
of a drug is not possible without the relationship between the pore size of the
membrane and the molecular dimensions of the drug. PO Res. Br. 9–11; see
RAN 4–6.
The majority agrees with the Requester. The claim is an apparatus
claim, not a method of delivering drugs. It is not disputed that claim 1 is
directed to a drug delivery device, and that the claims structurally define the
device as a capsule and nanopore membrane. The particular drug that is
recited as present within the capsule’s reservoir is only defined by size and
only in relation to the pore size of the nanopore membrane.
Language in an apparatus or product claim directed to the function,
operation, intent-of-use, and materials upon which the components of the
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structure work that does not structurally limit the components or patentably
differentiate the claimed apparatus or product from an otherwise identical
prior art structure will not support patentability. See, e.g., In re Rishoi,
197 F.2d 342, 344–45 (CCPA 1952); In re Otto, 312 F.2d 937, 939–40
(CCPA 1963); In re Ludtke, 441 F.2d 660, 663–64 (CCPA 1971); In re
Yanush, 477 F.2d 958, 959 (CCPA 1973).
The majority agrees that the drug limitation in this case represents an
intended use of the device that is otherwise structurally defined by the
claims, namely, as having a membrane with a pore size of 2 to 100 nm.
Alternatively, the drug limitation in the claim represents materials upon
which the membrane of the device works to provide for delivery of the
drugs. Under either rationale, the presence of the drug itself does not
patentably distinguish a drug delivery device having an identical structure
that is otherwise capable of containing such a drug within its reservoir.
While features of an apparatus may be recited either structurally or
functionally, claims directed to an apparatus must be distinguished from the
prior art in terms of structure rather than function. In re Schreiber, 128 F.3d
1473, 1477–78 (Fed. Cir. 1997). In Schreiber, a nozzle for dispensing oil
from an oil can was found to anticipate a claim for a dispensing top for
passing popped popcorn kernels because “[i]t is well settled that the
recitation of a new intended use for an old product does not make a claim to
that old product patentable.” Id. at 1477. The Federal Circuit further
determined that there were no distinguishing features of the oil can nozzle
such that “the examiner was justified in concluding that the opening of a
conically shaped top as disclosed [in the prior art] is inherently of a size
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sufficient to ‘allow[] several kernels of popped popcorn to pass through at
the same time.’” Id. 1478. Accordingly, the Board properly shifted the
burden to the Appellant to show that the prior art structure could not meet
this intended use requirement. Id.
In the same way that an affirmative claim limitation reciting
dispensing popcorn is not considered sufficient to distinguish a dispensing
device that dispenses oil, the generic recitation of a drug contained in the
device’s reservoir, limited only by its size relative to the pore size, does not
patentably distinguish a drug delivery device with the same capsule and
nanopore membrane because the drug’s presence does not structurally limit
the device itself. Rishoi, 197 F.2d at 344–45; Otto, 312 F.2d at 939–40;
Ludtke, 441 F.2d at 663–64; Yanush, 477 F.2d at 959.
The presence of a drug in the reservoir does not change the
requirement that the nanopore membrane have a specific pore size of
“between 2–100 nm.” The further limitation that the pore size be “1-5 times
the molecular dimensions of the drug such that the pores control the rate of
diffusion of said drug to achieve zero-order release of the drug” is an
intended use of the device to administer drugs with such molecular
dimensions. Thus, the membrane pore size makes the device capable of
achieving zero-order release when a drug of the recited dimensions is
included in the drug delivery device. In our view, the presence of a drug
which is outside the dimensions recited in claim 1 should not patentably
distinguish the claim from a device that otherwise meets all the structural
limitations of the claim. To determine otherwise would create the untenable
situation where prior art drug delivery devices would be capable of being
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patented over and over again merely by changing which conventional drugs
are contained therein.
Accordingly, we determine that claim 1 is properly construed as a
drug delivery device comprising a capsule having a fluid impermeable wall
defining a reservoir and at least one port in communication with a nanopore
membrane having pores between 2 and 100 nm. The capsule reservoir must
be structured (i.e., sized) to be capable of comprising a drug in an amount to
provide therapy for several weeks to about six months. In other words, the
capsule reservoir must be capable of holding at least a several week supply
of a drug having a size of between 0.4 and 100 nm (i.e., where the drug is 1–
5 times smaller than a pore size of 2–100 nm).
Patent Owner’s argument that subject matter added to claim 1 was
suggested by the Requester as being structural and, thus, cannot later be
argued as non-structural is without merit. PO Reb. Br. 9. We interpret the
claims as amended before us, and disagree with the Requester’s prior
arguments and the Examiner’s determination that such amendments indeed
limit the structure of a drug delivery device.
Claim 20
Unlike claim 1, claim 20 is directed to a method of delivering a drug.
Thus, unlike the apparatus claim 1, the method claim is properly interpreted
to include an affirmative step of providing a drug having the recited
dimensions with respect to the pore size of the nanopore membrane. In this
case, the claim is directed to the method of using the device, and we must
consider whether the prior art teaches or suggest all the recited steps of the
method. With respect to this claim, we decline to find the size of the drug as
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a function of the membrane pore size to be a functional limitation, as argued
by Requester. See PO App. Br. 19–20.

PROPOSED ANTICIPATION REJECTIONS
Keller
Claim 1
The Examiner found that Keller “does not describe a drug delivery
device containing a drug in an amount that provides therapy for a period of
several weeks to six months, and where the membrane pore size is 1 to 5
times the molecular dimensions of the drug.” RAN 9, 28 and 29.
Requester contends that Keller describes all the structural
requirements of the drug delivery device capsule recited in the claims. Req.
App. Br. 17–20. Thus, according to Requester, the claim amendments fail to
distinguish the device of Keller. Req. Reb. Br. 12; Req. App. Br. 17–18.
In light of our interpretation of claim 1 above, we disagree with the
reasoning provided by the Examiner. However, the Examiner did not err in
failing to adopt the anticipation rejection of Keller for an alternative reason.
As discussed above, in order to anticipate claim 1, a drug delivery
device having the capsule described must be structurally capable of
providing at least a several week supply of a drug having a size of 0.4 to 100
nm. Requester has not established that the capsule described in Keller is
capable of storing such a supply of any drug known in the art. Keller
teaches a capsule that is “about 10 to about 2000 microns or more in
diameter D and about 10 to about 1000 microns in height H.” Keller 8, ll. 3–
6. We calculate that such a sized structure has a maximum overall volume
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of about 3.14µl.7 We have insufficient evidence to find that a 3.14µl or less
reservoir is capable of containing a drug in an amount for therapy over
several weeks.
Accordingly, we affirm the Examiner’s non-adoption of the proposed
anticipation of claim 1, and the claims that depend therefrom, based on the
teachings of Keller.
Claim 20
Similarly, claim 20 includes an affirmative step of providing a capsule
and a drug in an amount for therapy over at least several weeks. We have
insufficient evidence to find that the insulin described in Keller is capable of
being stored in a 3.14µl or less reservoir in an amount for therapy over
several weeks.
Accordingly, we affirm the Examiner’s non-adoption of the proposed
anticipation of claim 20, and the claims that depend therefrom, based on the
teachings of Keller.

Desai
Claim 1
The Examiner found that Desai, like Keller, does not disclose an
implantable drug delivery device whose reservoir is filled with a drug and
whose pore size is 1 to 5 times the molecular dimensions (Stokes diameter)
of the drug. RAN 11. The Examiner finds that “there is no mention of any

7 Keller’s teaches the capsule as a cylinder with a maximum diameter of
2000 microns (or 2 mm) and a maximum length of 1000 microns (or 1 mm).
We thus approximate the calculation of volume of the cylinder as follows: π
x (diameter/2)2 x length = π x (2/2 mm)2 x 1mm = ~3.14 mm3 = ~3.14 µl.
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therapeutic amount of IgG that was required” or any “indication that the
amount of IgG released was a sufficient amount to provide a therapeutic
level for some unspecified disease.” RAN 30.
As with Keller, Requester contends that Desai describes all the
structural requirements of the drug delivery device recited in the claims.
Req. App. Br. 24–27. Thus, according to Requester, the claim amendments
fail to distinguish the device of Desai. Req. Reb. Br. 12. Req. App. Br. 24.
In light of our interpretation of claim 1 above, we disagree with the
reasoning provided by the Examiner. Desai expressly describes a device
having “a mini-diffusion chamber [] designed and machined out of
transparent acrylic. It consisted of two compartments A and B with fixed
volumes of 2 ml, separated by the biocapsule membrane, sealed with o-
rings, and finally screwed together (Fig. 5).” Desai 224, col. 2, last full ¶.
Figure 5 is reproduced below.

Figure 5 depicts a schematic view of a rotating diffusion chamber
used to test microfabricated membranes comprising two 2 mL chambers A
and B, each having sampling injection ports and separated by a
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microfabricated membrane array. Desai 226, Figure 5, caption and 224, col.
2, last full ¶.
The ’614 Patent describes a preferred drug delivery device having “an
internal volume of approximately 250 µL to several milliliters.” ’614
Patent, col. 5, ll. 35–38. The ’614 Patent also describes a specific example
drug delivery device having a reservoir size of 500 µL. Id., ll. 58–59.
Desai’s 2 mL reservoir volume (compartment A) falls within the preferred
volume described in the ’614 Patent. Accordingly, the reservoir of Desai’s
device is of an identical size or larger than that described in the ’614 Patent.
Thus, it is reasonable to find that the device described in Desai is of
sufficient size for storing at least a several week supply of a drug having a
size of between 0.4 and 100 nm. Because the reservoir falls within the size
range described in the ’614 Patent, the burden shifts to Patent Owner to
show that such a reservoir is not of sufficient size for storing at least a
several week supply of a drug having a size of between 0.4 and 100 nm.
This burden was not met.
Desai further describes membranes fabricated with nanopore sizes of
18, 66 and 78 nm, which fall within the claimed pore size range of 2 to 100
nm.
Accordingly, we find that the device described in Desai meets all the
structural limitations of the claimed drug delivery device. We further find
that the membrane and capsule of Desai are capable of achieving zero-order
release for a drug having dimensions which are 1–5 times smaller than the
pore sizes of 18, 66 and 78 nm, which includes overlapping ranges of 3.6–18
nm (drug dimension 1–5 times an 18 nm pore size), 13.2–66 nm (drug
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dimension 1–5 times a 66 nm pore size), and 15.6 to 78 nm (drug dimension
1–5 times a 78 nm pore size). In a case such as this where patentability rests
upon a property of the claimed device not disclosed within the art
(achievable release rates), the PTO has no reasonable method of determining
whether there is, in fact, a patentable difference between the prior art device
and the claimed device. Therefore, where the claimed and prior art products
are identical or substantially identical, the PTO can require an applicant to
prove that the prior art products do not necessarily possess the characteristics
of his claimed product. In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Patent Owner argues that Figure 9 of Desai does not show a zero-
order release rate for IgG with an 18 nm pore-sized membrane, and the
Examiner adopts this reasoning as evidence that Desai’s device does not
anticipate. PO Res. Br. 16; RAN 31 and 33.
However, the claimed invention does not require a zero-order release
be achieved for all potential drugs with the respective molecular dimensions.
The device need only be capable of achieving zero-order release of a so
dimensioned drug. We find that the membrane capsule of Desai would have
been capable of achieving zero-order release for other drugs that do not have
the particular “size, flexibility and configuration of the IgG antibody,”
making the diffusion behavior of IgG particularly difficult to characterize, as
discussed in Desai. Desai, Section 4.1, 229, col. 2 to 230, col. 3 (“[S]tudies
have disagreed on the actual dimensions of the molecule.”). In particular,
there is sufficient evidence to find that, because the device is substantially
identical to that described in the invention, the drug delivery device of Desai
having an 18 nm pore size, would have albumin diffusion rates substantially
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similar to those for the devices described in the ’614 Patent having 13 nm
and 26 nm pore-sizes, respectively, as shown in Figure 6 of the ’614 patent.
’614 Patent, col. 3, ll. 62-67 and Figure 6.
Accordingly, we reverse the Examiner, and enter a new ground of
rejection of claim 1 as anticipated under 35 U.S.C. § 102(b) by Desai.
Claim 3
Claim 3 depends from claim 1 and further recites that the “capsule is
coated with a porous polymeric material.” Requester argues that Desai
describes “bonding the two halves together with ‘a thin [polymer] layer that
is patterned on the outer membrane edges.” Req. App. Br. 26 (quoting Desai
223, col. 2). Requester acknowledges that the Examiner rejected this
argument. Id. n.1 (citing the Non-final Office Action mailed January 2,
2014 (“Non-final Action”)). We agree with the Examiner that the adhesive
polymer layer “patterned on the outer membrane edges” is not reasonably a
coating on the capsule. See Non-final Action 19. We also agree with the
Examiner that Requester has not shown that the polymer material described
in Desai is porous. Id. Accordingly, we affirm the Examiner’s non-adoption
of the proposed anticipation of claim 3 based on the teachings of Desai.
Claims 10–16, and 30
Claims 10–16, and 30 further define the drug recited in claim 1. For
the reasons discussed above, the drug added to the drug delivery device and
its properties do not patentably distinguish the drug delivery device recited
in the claims over the substantially identical device described in the prior art.
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Accordingly, we reverse the Examiner, and enter a new ground of
rejection of claims 10–16, and 30 as anticipated under 35 U.S.C. § 102(b) by
Desai.
Claim 19
Claim 19 depends from claim 1 and further recites that the nanopore
membrane is “microfabricated from silicon, poly silicon, a combination of
silicon materials, polymer or co-polymer.” Requester argues that the
capsule of Desai has a nanopore structure as recited in claim 19. Req. App.
Br. 27. The Examiner previously found “Desai describes the capsule as
being prepared from polysilicon (See legend for Figure 1 on page 223).”
Non-final Action 18. In fact, Desai describes the capsule itself made from a
silicon wafer and the membrane fabricated onto that wafer but substantially
comprising a deposited polysilicon layer. Desai 223, col. 1–2, Section 2.1
“Membrane fabrication” and Figure 1. Accordingly, we find that claim 19
reads on Desai’s nanopore membrane, which comprises a combination of
silicon materials.
Accordingly, we reverse the Examiner, and enter a new ground of
rejection of claim 19 as anticipated under 35 U.S.C. § 102(b) by Desai.
Claim 20
Unlike claim 1, as discussed above, claim 20 describes an affirmative
step of providing in a capsule reservoir at least a several week supply of a
drug with molecular dimensions 1–5 times smaller than the pore size of the
nanopore membrane.
Desai describes a 2 ml volume reservoir as being used to measure
diffusion of glucose and insulin. Desai 224, col. 2, last full ¶ (compartment
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A of Fig. 5). According to the Sigma catalog of record, insulin is identified
as having a Stokes radius of 11.9 Å – which we find corresponds to a
Stoke’s diameter of 23.8 Å or 2.38 nm. The smallest pore size disclosed by
Desai is 18 nm. Thus, to meet the requirements of the claim when the pore
size is 18 nm, the art must teach a drug provided in the reservoir with
molecular dimensions of 3.6 nm to 18 nm. A 2.38 nm dimension is too
small to meet this requirement. The record appears to reflect that the size of
glucose is even smaller than that of insulin. See e.g., Req. Reb. Br. 10.
Accordingly, this description does not anticipate the claimed invention.
Another embodiment of Desai describes a device for measuring the
diffusion of IgG through a biocapsule as shown in Figure 2, also with an 18
nm pore-sized membrane. Desai 226, col. 2, first full ¶. IgG is recognized
as having a Stokes diameter of about 10.8 nm, and thus a pore size of 18 nm
is 1–5 times the size of the IgG, i.e., the IgG’s dimensions fall within 3.6 nm
to 18 nm. However, the single example describing the diffusion of IgG
takes place in a biocapsule device having a reservoir of only 2 µl. Id.; see
Fig. 2. Desai teaches that diffusion of IgG was monitored over a period of
14 days, which demonstrates that the device is capable of delivering a drug
for several weeks. However, neither Requester nor the Examiner has shown
that a reservoir of only 2 µl is capable of holding a several week therapeutic
supply of IgG for 14 days. Desai is silent as to the amount of IgG loaded
into the reservoir, and the record is silent as to what amount of IgG is a 14-
day dosage for any therapeutic use.8

8 The Examiner notes that infusions of IgG generally require grams levels of
the product, but there is no evidence of record as to a therapeutic supply of
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Accordingly, we find the teachings of Desai insufficiently specific to
anticipate the method recited in claim 20, or the claims that depend
therefrom.
Martin 2001
Patent Owner asserts that the Examiner was correct in determining
that Martin 2001 is not prior art. The Examiner found that the Martin
Declaration9 “establishes that Martin 2001 is not a reference by ‘another.’
Thus, Martin 2001 is not prior art against the Martin ’614 Patent.” RAN 39.
We find no error in the Examiner’s determination that Martin 2001 is
not prior art. Requester presents no factual dispute with respect to the
Martin Declaration and, instead, discusses additional prior art that is not
cited in a proposed rejection and, thus, has not been evaluated by the
Examiner. Req. App. Br. 35. In our review of the BioMEMs abstract10
identified by Requester (id.), we find that the abstract lacks any details about
the microcapsules and thus fails to describe a device comprising a capsule
and nanopore membrane as claimed. Requester presents no other “patents or
printed publications” describing the contents of the BioMEMs Conference
disclosure, if any, or the Viadur product of record upon which we could rely
as prior art in this reexamination. See 35 U.S.C.

IgG. See RAN 31; see also Declaration of Tejal A. Desai ¶ 8, executed
October 24, 2014 (“Desai Declaration” or Desai Decl.).
9 Declaration of Francis J. Martin under 37 C.F.R. § 1.132, executed on
September 20, 2013 (“Martin Declaration” or “Martin Decl.”).
10 C. Groves, “BioMEMS and Nanotechnology: Opening Up New
Opportunities for Drug Delivery,” Abstract, BioMEMs & Biomedical
Nanotechnology World 2000 Conference, Columbus, Ohio, September 23–
25, 2000.
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§ 301 and 311 (limiting the scope of reexamination to grounds based on
“prior art consisting of patents and printed publications”).
Accordingly, we find no error in the Examiner’s decision not to reject
claims based on Martin 2001.

PATENT OFFICE INITIATED NEW GROUND OF REJECTION
Obvious over Desai
Claim 1
Desai teaches a 2 ml capsule as recited in claim 1, in which the
nanopore membrane has pore sizes of 18 nm, 66 nm and 78 nm. As
discussed above, we find that a 2 ml capsule falls within the reservoir size
range described in the ’614 Patent, and thus shift the burden to Patent Owner
to show that a 2 ml capsule is not of sufficient size to contain at least several
weeks of a drug.
Moreover, it would have been obvious to one skilled in the art to
adjust the size of the reservoir of the biocapsule of Desai shown in Figure 2
to conveniently contain any amount of any particular drug, the size of the
device being only limited by the ability to be surgically implanted. See ACP
36.
For example, Wong (WO 01/30323 A2, published May 3, 2001, and
naming Vernon G. Wong, et al. as inventors) describes an implantable
delivery device for long-term administration of drugs to the eye. Wong,
Abstract. Wong teaches that “[t]he volume of the device is such that the
device holds sufficient amount of the drug to provide a continuous delivery
over the implant’s long delivery period, e.g., several weeks, months, or even
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longer, i.e., up to 2 or more years. The volume needed thus depends on
characteristics such as drug solubility, drug delivery rate, period of delivery,
drug’s half life, etc.” Wong, 11:2–12:3. Accordingly, the skilled artisan is
charged with the skill to size a drug delivery device’s reservoir volume to
hold a desired amount of any particular drug. In an obviousness analysis, it
is proper to “take account of the inferences and creative steps that a person
of ordinary skill in the art would employ.” KSR, 550 U.S. at 418.
Also, it would have been obvious for one of ordinary skill in the art to
have adjusted the size of the nanopores of the membrane using the
techniques described in Desai to achieve any desired pore size, because
Desai teaches a membrane manufacturing process for “achieving uniform
and well-controlled pore diameter, length and configuration” such that
“biocapsules can potentially be engineered and optimized precisely to one’s
desired specifications.” Desai 230 col. 1, first full ¶ and 222, col. 2, first full
¶. The skilled artisan would have been capable of using the testing
procedures described in Desai to optimize the pore size to achieve the most
desirable release profile for any particular drug.
Accordingly, claim 1 would also have been obvious to one of ordinary
skill in the art in view of Desai alone or further in view of Wong.11

11 Under the claim interpretation argued by the Patent Owner and adopted by
the dissent, it also would have been obvious to include the drug disclosed in
Wong within the device rendered obvious over Desai and Wong for the long
term administration to the eye, as described in Wong. Desai 230, col. 1,
Wong 11:2–12:3.
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Claims 10–16, 19, and 30
Claims 10–16, 19, and 30 would have also been obvious over the
teachings of Desai for the reasons discussed above with respect to the new
anticipation rejection of claims 10–16, 19, and 30.
Claim 9
Claim 9 depends from claim 1 and further limits the capsule to being
made from “titanium alloy, surgical grade stainless steel, or a polymeric
material.” Desai teaches a microfabricated device designed with
“microfabricated inorganic membranes, with uniform and well-controlled
pore sizes in the tens of nanometer range, may be able to provide better size-
based immunoisolation than conventional polymeric biocapsule
membranes.” Desai 222, col. 2, first full ¶. In other words, Desai identifies
that drug delivery devices made of polymeric material were conventional in
the art. Indeed, even the ’614 Patent acknowledges that polymeric devices
capable of delivering potent drugs for up to one year were known in the art
at the time of the invention, although known to have limitations. ’614
Patent, col. 1, l. 57 to col. 2, l. 27. See also Atkinson, col. 4, ll. 49–66 and
col. 8, l. 58 to col. 9, l. 13 (describing manufacturing a polymeric drug
delivery capsule via extrusion).
In an obviousness analysis, “the question is whether there is
something in the prior art as a whole to suggest the desirability, and thus the
obviousness, of making the combination,” not whether there is something in
the prior art as a whole to suggest that the combination is the most desirable
combination available. In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004).
Thus, it would have been obvious to one of ordinary skill in the art to form
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the capsule of Desai using polymeric materials as in conventional polymeric
drug delivery capsules.
Claim 20
As discussed above, claim 20 describes an affirmative step of
providing a capsule having a reservoir and providing in that reservoir at least
a several week supply of a therapeutic agent, such that the pore size of the
nanopore membrane is 1–5 times the molecular dimensions of the drug.
Desai does not expressly teach a step of providing a therapeutic agent having
these features.
Nonetheless, it would have been obvious to one of ordinary skill in
the art at the time of the invention to provide a therapeutic agent in the
reservoir of device described in Desai and in an amount appropriate for
long-term therapeutic use of those drugs. The capsule of Desai uses a
membrane that was fabricated using inorganic materials which have an
advantage over polymeric materials in the ability to define uniform and
precise pores. Desai 222, col. 2, first full ¶. Desai also teaches that these
membranes have “biocompatibility, ease in sterilization, [and] thermal and
chemical stability, [which] may provide a significant advantages for
biomedical applications.” Desai 221, Abstract. Thus, it would have been
obvious to one of ordinary skill in the art to provide any drug in the capsule
of Desai that was known to be used with polymeric capsules for long-term
drug delivery. Such drugs are well known in the art, as admitted by Patent
Owner’s ’614 Patent. See ’614 Patent, col. 1, ll. 28–37 and col. 1, l. 63 to
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col. 2, l. 20.12 The background knowledge attributable to one of ordinary
skill in the art includes what was admittedly known in the art at the time of
the invention. Constant v. Advanced Micro-Devices Inc., 848 F.2d 1560,
1570 (Fed. Cir. 1988) (“A statement in a patent that something is in the prior
art is binding on the applicant and patentee for determinations of anticipation
and obviousness.”); In re Nomiya, 509 F.2d 566, 570–71 (CCPA 1975)
(using the admitted prior art in applicant’s Specification to determine the
patentability of a claimed invention); In re Fout, 675 F.2d 297, 301 (CCPA
1982) (“[i]t is not unfair or contrary to the policy of the patent system that
appellants’ invention be judged on obviousness against their actual
contribution to the art”) (footnote omitted)).
As discussed in further detail below, the Examiner determined that
The potency of drugs approved by the FDA is public
information. The knowledge of the potency of a drug combined
with its molecular dimensions (Stokes diameter) would permit
the person of skill in the art to determine if sufficient drug

12 See also U.S. Patent 5,601,835, issued February 11, 1997 to Bernhard A.
Sabel, et al. (teaching a polymeric drug delivery system for zero-order
delivery of L-dopa and dopamine (Stokes diameter = 13.8nm) directly to the
central nervous system for up to several months); U.S. Patent 5,035,891,
issued July 30, 1991 to Richard A. Runkel, et al. (teaching a polymeric
device for subcutaneous sustained administration of steroids, such as
estrogen, progesterone, an androgenic agent, testosterone, and/or trenbolone
acetate); U.S. 5,665,428, issued September 9, 1997, to Younsik Cha, et al.
(teaching polymer drug delivery devices to deliver a therapeutically effective
amount of a variety of sized pharmaceutically active polypeptides, including
monoclonal antibodies and soluble vaccines, over a prolonged period of
time); U.S. 6,716,444 B1, issued April 6, 2004 to Daniel Castro et al.
(teaching a polymeric drug delivery device (a polymeric coating on a
substrate such as a stent) that for localized delivery of a variety of anti-
thrombogenic drugs for an extended period of time).
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could be loaded into the reservoir of the device in order to
provide therapy for several weeks to about six months.
RAN 48. We agree with the Examiner’s reasoning and find that this
knowledge of a skilled artisan also applies to the drug delivery process of the
prior art. Thus, it would have been obvious to one of ordinary skill in the art
to provide a drug in Desai’s capsule in an amount sufficient for long-term
diffusion over at least several weeks, as is known in the art. 13
The skilled artisan would also have been capable of modifying the
membrane pore-size for an optimal rate of release for any particular drug,
including a zero-order14 release rate, because Desai particularly teaches
improved pore-size control using the particular membrane manufacturing
process described therein and “[t]he ability of microfabricated biocapsule
membranes to perform size-based exclusion of biomolecules.” Desai 224, ¶
spanning col. 1–2. For example, Desai measures the amounts of various
sized polystyrene beads and IgG that diffuse out of capsules with various
pore sizes. See 224, ¶ spanning col. 1–2 and 226, Section 2.5, spanning col.
1–2. Desai also describes testing the diffusion of insulin, glucose, and IgG
molecules with respect to pore-size. Desai 224, last full ¶ and ¶ spanning
pp. 224 and 225. The results of these test suggest the skilled artisan would

13 Under this same rationale the drug delivery device of claim 1 would have
been obvious to one of ordinary skill in the art even as interpreted by the
dissent.
14 The references identified in note 10 also teach that a zero-order release
rate was desired for many of these drugs and was often achieved in known
polymeric drug delivery capsules. Thus, for the skilled artisan using the
same drugs in the device of Desai, Desai would have suggests modifying the
membrane pore-size to obtain a zero-order release rate.
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design a membrane pore size with respect to the dimensions of the desired
drug whose delivery is sought. See 227, Section 3.1, spanning col. 1–2 and
228, Section 3.3, spanning col. 1–2.
Although Desai teaches manufacturing pore sizes only as small as 18
nm, Keller describes a process similar to that described in Desai and capable
of forming pores as small as 2 nm. See Keller, claim 15. Thus, achieving
even smaller pore sizes is not outside of the skill of the ordinary artisan.
Accordingly, a step of providing a therapeutic agent in a capsule with
membrane pores sized for an optimal rate of release would have been
obvious to one of ordinary skill in the art based on the teachings of Desai.
Claims 33 and 34
Claim 33 limits the drug provided in the capsule reservoir to “a
peptide, a protein drug, [or] a polynucleic acid.” Claim 34 further limits the
drug provided in the capsule to “a growth factor, hormone, antiinfective
agent, cytokine, immune-modulator, anti-tumor agent, or hormone
antagonist.”
Desai describes “adequate hormonal diffusion out of the biocapsule
for therapeutic application.” Desai 230, last ¶. Thus, a step of providing a
hormone to Desai’s device would have been obvious to one of ordinary skill
in the art for the purposes described therein.15

15 Under this same rationale the drug delivery device of claims 11 and 12
also would have been obvious to one of ordinary skill in the art even as
interpreted by the dissent.
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Claims 21, 22, 31, and 32
Claims 21, 22, 31, and 32 depend from claim 20 and further recite that
the therapeutic agent is provided in either an aqueous solution or suspension
(claims 21 and 31) or in a dry form (claim 32), in other words, it forms an
aqueous suspension by introduction of a biological fluid from the medium
surrounding the device (claim 22).
Desai describes providing “a suspension of beads” (Desai 224, ¶
spanning col. 1–2) in the capsule and that IgG “was pipetted” into a capsule
(Desai 226, col. 2, first full ¶), but fails to expressly state that these
components were added in an aqueous solution or suspension as recited in
the claims. Desai also describes glucose and insulin added to the
compartments of a capsule. Id., ¶ spanning 224–225. However, Desai is
silent as to in what form glucose and insulin were added.
The desired components must be delivered into the capsule and
carried through the pores in some form that is compatible with bodily fluids.
Determination of best delivery methods would have been within the skill of
the ordinary artisan in the well-known art of implantable biocapsules for
drug delivery. See ’614 Patent, col. 1, l. 63 to col. 2, l. 20. This finding is
consistent with the teachings in Desai of pipetting material into a capsule
and providing materials in a suspension. Accordingly, we find that it would
have been obvious to one of ordinary skill in the art to have provided a drug
in either a dry form to take advantage of body fluids for mobility or in an
aqueous solution or suspension, which would be most compatible with a
human body.
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Obvious over Desai in view of additional prior art
Claims 21, 22, 31, and 32
To the extent it would not have been obvious to one of ordinary skill in
the art to have provided the drug of claim 20 in alternatively a dry form or in
an aqueous solution or suspension, as discussed above, we find this feature
obvious further in light of additional prior art of record, as argued by
Requester. See Req. App. Br. 34. The Examiner previously found that Haak
(U.S. 5,158,537, issued October 27, 1992 to Ronald P. Haak, et al.) teaches
“hydrating a reservoir layer of an implantable delivery device.” Non-final
Action 29. The Examiner’s finding is partially in error. Haak is directed to
an “iontophoretic drug delivery device” using an electrode assembly which is
particularly described “for delivering a beneficial agent through a body
surface such as intact skin or a mucosal membrane.” Haak, col. 7, ll. 6–11.
Thus, Haak is not directed to an “implantable delivery device.”
Haak teaches that it was known in the art at the time of the invention
to use hydrophilic polymers with dry forms of drugs that “can be hydrated
by absorbing sweat or water from transepidermal water loss” or saliva.
Haak, col. 3, ll. 47–66. Haak states that “water is a biocompatible, highly
polar solvent and therefore preferred for ionizing many drug salts.” Id., col.
3, ll. 53–54.
According to Haak, a hydrophilic polymer device is undesirable for
iontophoretic drug delivery devices because
the non-hydrated hydrophilic polymer components must first
absorb sufficient quantities of water from the body before the
device can operate to deliver drug. This delivery start up period
can take in excess of 8 hours. This delay makes many devices
unsuited for their intended purpose. For example, when using
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an iontophoretic delivery device to apply a local anesthetic in
preparation for a minor surgery (e.g., surgical removal of a
mole), the surgeon and the patient must wait until the drug and
electrolyte reservoirs of the delivery device become sufficiently
hydrated before the anesthetic is delivered in sufficient
quantities to induce anesthesia.
Id., col. 4, ll. 16–28. While this delay is problematic for transdermal
administration that relies on an electrolyte solution to be present for
operation, the skilled artisan would understand that for a long-term
implantable device, such as described in Desai, an 8 hour delay to allow
body fluids to enter a capsule and solubilize the drugs would be of little
consequence. Thus, it would have been obvious to one of ordinary skill in
the art to provide a drug in a dry form and rely on body fluids for hydration
of the drug after implantation, as described in Haak for hydrophilic polymer
drug delivery devices, because Desai teaches an implantable biocapsule that
is a useful delivery system for a therapeutic as an alternative to hydrophilic
polymeric drug delivery devices. Desai 222 (col. 2).
The Examiner also found that Wong (WO 01/30323 A2, published
May 3, 2001, and naming Vernon G. Wong, et al. as inventors) teaches “a
device having orifices in the walls through which the body fluids can enter
to dissolve the drug entrapped in the device.” Non-final Action 30. Wong
teaches that “[t]he drug can be deposited in the device as a dry powder,
particles, granules, or as a compressed solid. The drug may also be present
as a solution or be dispersed in a polymer matrix.” Id., ¶ spanning pp. 14–
15. Wong also teaches that “the influx of body fluids and the efflux of drug
solution occurs primarily, if not entirely, through the orifice.” Id. at 16, ll. 5–
6.
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Accordingly, it would have been obvious to one of ordinary skill in
the art to provide a drug in the capsule in either a dry form or in a solution,
as these are described as alternatives for known implantable drug delivery
devices, as taught by Wong.
The Examiner determined that there was no motivation to combine
Desai with Haak or Wong because “[t]he capsule of Desai contains islet
cells that produces insulin” which cannot be hydrated from a dry form.”
Non-final Action 75–77 (Rejections 18 and 19). The skilled artisan would
not have found the teachings of Desai limited to only the delivery of insulin
producing islet cells. Desai describes broader applications for such a
capsule beyond merely holding insulin producing islet cells. See Desai 221,
Abstract (“The application of microfabrication technology to create precise
separation and isolation membranes for biomedical applications is described.
. . . Microfabrication technology may also be applied to other materials of
interest for the development of highly controlled membranes.”). Desai also
teaches its microfabricated membrane as an alternative for “conventional
polymeric immunoisolating biocapsules.” Id., 230, col. 1, last full ¶. Thus,
the skilled artisan would have used the device of Desai using a drug in forms
known in the art for use in polymeric biocapsules. Accordingly, the
Examiner’s finding and basis for not adopting the proposed rejections based
on Desai in view of Haak or Wong is not supported by the record. 16

16 Under this same rationale the drug delivery device of claim 10 also would
have been obvious to one of ordinary skill in the art over Desai and Haak
and/or Wong, even as interpreted by the dissent.
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Claim 4–6, and 8
Claims 4–6, and 8 include further structural limitations of the device
capsule of claim 1. Claim 4 recites that the capsule is “non-deformable” and
end caps for closing two open ends. Claim 5 recites “bullet-shaped” tapered
end caps. Claim 6 recites that the capsule is “substantially cylindrical.”
Claim 8 recites that the capsule is “substantially elliptical.” Requester
contends that claims 4–6 and 8 are obvious over Desai in view of Atkinson
(U.S. Patent 5,443,461, issued August 22, 1995, to Linda E. Atkinson et al.).
Req. App. Br. 32–33.
Desai teaches a biocapsule having a compartment and a single
membrane, but does not teach the recited structural features of claims 4–6,
and 8. The Examiner previously found that Atkinson “describes a
segmented device for simultaneous delivery of multiple agents, where the
device includes opposing end caps 15 and 16. Non-final Action 22–23.
Indeed, Atkinson teaches a polymer capsule having bullet shaped ends
covering a cylindrical or oval shaped body. Atkinson, col. 3, l. 66 to col. 4,
l. 1, col. 4, ll. 49–66. Atkinson does not expressly identify a benefit to the
particular shape of its capsule, though it does describe that the capsule may
be loaded at the ends then covered with the caps. Id. col. 8, l. 67 to col. 9, l.
2.
The use of a device manufactured as described in Desai, but having
the overall shape described in Atkinson, would have been obvious to one of
ordinary skill in the art either to provide an easy way to load the device (via
a capped end and/or a port in such end) or for the ease of implantation into
the body by a bullet-shaped capsule as opposed to the square shaped capsule
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shown in Figure 2 of Desai. The shape appears to be desirable in the art.
See e.g., Wong 11, ll. 21–24 (teaching cylindrical or elliptical polymeric
drug delivery devices); Yamagata,17 col. 7, ll. 14–15 (describing a drug
delivery device in the form of “a spherical or oval form as a suppository”);
Chen,18 col. 4, ll. 18–19 and Figure 1 (showing “an elongated substantially
cylindrical capsule”).
Claims 35 and 36
Claims 35 and 36 further limit the type of drug and specifically recite
that the drug is interferon alpha 2b (claim 35) or interferon beta (claim 36).
Requester contends that claims 35 and 36 are obvious over Desai in view of
Yamagata. Req. App. Br. 33. The Examiner previously found that
Yamagata teaches “a solid matrix, implantable tablet of alpha-interferon”
and that “the person of skill in the art recognizes that interferon-α embraces
both subtypes 2a and 2b.” Non-final Action 25 and 32 (Rejection 15) (citing
Yamagata, col. 8, ll. 4–12, Example 1; see also col. 3, l. 60). The Examiner
also found that Yamagata teaches “the use of a variety of interferons,
including interferon beta, in a drug delivery system.” Id. 26 and 32
(Rejection 15) (citing Yamagata col. 3, ll. 56–60).
The Examiner determined that
It would have been obvious to the person of ordinary skill in the
art at the time of the invention to modify the device of Desai by
filling it with interferon alpha 2b or interferon beta as taught by
Yamagata ’993 in order to create a controlled release device for

17 U.S. 5,628,993, issued May 13, 1997, to Yutaka Yamagata et al.
(discussed in further detail below with respect to claims 35 and 36).
18 U.S. 6,113,938, issued September 5, 2000, to Guohua Chen et al. (of
record in this reexamination).
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a bioactive compound required for the treatment of the
associated diseases, such as hepatitis and multiple sclerosis,
respectively.
Non-final Action 32. We agree with the Examiner’s reasoning as discussed
above with respect to claim 20.19
Claim 37 and 38
Claims 37 and 38 limit the type of drug to small molecular weight
molecules, and particularly small molecular weight “pain medication or an
anti-psychotic agent.” Requester contends that claims 37 and 38 are obvious
over Desai in view of Dunn (U.S. Patent 5,888,533, issued March 30, 1999,
to Richard L. Dunn). Req. App. Br. 33–34. The Examiner previously found
that Dunn teaches a drug delivery device “implant containing doxycycline
(Example 7) or naltrexone (Example 13), molecules having a [molecular
weight] of 444.43 and 341.4 daltons, respectively, each less than 1000
daltons.” Non-final Action 27 (citing Dunn, col. 9, ll. 22–24, col. 14, l. 64 to
col. 15, l. 16 (Example 7) and col. 16, ll. 5–14 (Example 13)). The
Examiner has identified these as small molecules and anti-psychotic agents.
Id.
The Examiner determined that there would have been no reason to
combine the small molecule materials with the capsule of Desai because “the
nanopore sizes would permit free diffusion of the analgesic from the capsule
just like insulin.” Non-final Action 33. Indeed, Desai’s smallest pore size
of 18 nm is too large to have the controlled release recited in the claims for

19 Under this same rationale the drug delivery device of claims 13 and 14
also would have been obvious to one of ordinary skill in the art over Desai
and Yamagata, even as interpreted by the dissent.
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molecules as small as those described in Dunn. However, as discussed
above, Keller teaches a similar process for forming a microfabricated
membrane to achieve a pore size as small as 2 nm. Keller, claim 15. Thus,
achieving smaller pore sizes are demonstrably within the skill of the
ordinary artisan. Thus, it would have been obvious to one of ordinary skill
in the art to use agents as taught by Dunn having small molecules for the
benefits of administering these drugs via an implantable device, such as
taught by Desai, and adjusting the pore size below the 18 nm taught by
Desai, as taught by Keller, to optimize the pore size for a desired controlled
release rate of the particular drugs.
Summary of New Grounds based on Obviousness
In sum, we enter a new ground of rejection of claims 1, 9, 10–16, 19–
22 and 30–34 under 35 U.S.C. § 103(a) as being unpatentable over Desai
alone or further in view of Wong.
We also enter new grounds of rejection of claims 21, 22, 31, and 32
under 35 U.S.C. § 103(a) as being unpatentable over Desai in view of Haak
and/or Wong.
We also enter new grounds of rejection of claims 35 and 36 under
35 U.S.C. § 103(a) as being unpatentable over Desai in view of Yamagata.
We also enter new grounds of rejection of claims 37 and 38 under
35 U.S.C. § 103(a) as being unpatentable over Desai in view of Keller and
Dunn.

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PROPOSED 35 U.S.C. § 314 REJECTIONS
Requester argues that Patent Owner’s amendments to claim 1
impermissibly broaden the scope of claim 1 under 35 U.S.C. § 314(a).
Patent Owner argues that to the extent the amendments to claim 1
incorporates limitations of now cancelled claims 18 and 24, the amendments
to claim 1 do not include all the limitations of the cancelled claims. Req.
App. Br. 36. We agree with the Examiner that claim 1 was not broadened in
its scope by the incorporation of limitations from other cancelled claims.
See RAN 49–51. We agree with the Examiner that the language added to
claim 1 is properly compared only to original claim 1 and not to the
cancelled claims and that the language added in all cases narrows the scope
of claim 1. Id.
Requester argues that Patent Owner’s amendments to claim 20 also
impermissibly broaden the scope of claim 20 under 35 U.S.C. § 314(a). As
with claim 1 above, Requester argues that to the extent claim 20 was
amended to incorporate limitations of cancelled claim 23, the amended
language does not include all of the limitations of cancelled claim 23. We
do not find this persuasive for the same reasons that claim 1 was not
impermissibly broadened.
Requester also argues that claim 20 was broadened by changing the
language “membrane having pores dimensioned to control the rate of
diffusion . . . ” to “membrane have pores with a pore size . . . such that the
pores control the rate of diffusion . . ..” According to Requester, “[t]he
amendment to claim 20 allows each pore of the membrane to be a different
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size, while original claim 20 required all the pores to have the same
dimensions.” Req. App. Br. 37 (underlining in original).
The Examiner determined that
The person of skill in the art would not interpret the limitation
wherein a “pore size (i) between 2 -100 nm” to suggest or
permit the pore sizes to vary within a single membrane. Such an
interpretation goes against logic. The only way to effectively
control the diffusion of the drug across the membrane is to have
uniform pore sizes. To suggest otherwise is to invite chaos and
unpredictability into the invention that runs counter to the entire
specification of the Martin ’614 patent.
RAN 50.
We disagree with the Examiner’s interpretation of the claim language
either before or after the amendment as necessarily requiring pores of the
same size. The Examiner has not provided any evidentiary support to the
finding that “[t]he only way to effectively control the diffusion of the drug . .
. is to have uniform pore sizes.” Nonetheless, we agree with the Examiner
that the scope has not changed. The original language read “said membrane
having pores dimensioned to control the rate of diffusion of said therapeutic
agent.” This language does not expressly require that the pores are
dimensioned, or sized, identically to “control the rate of diffusion.”
Likewise, the amended claim language reads “said membrane having pores
with a pore size . . . such that the pores control the rate of diffusion.” There
is no requirement that the pores of the amended claim language are the same
size to “control the rate of diffusion,” provided that each pore has a size as
recited in the claims.
Accordingly, we affirm the Examiner’s non-adoption of the proposed
rejections under 35 U.S.C. § 314.
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PROPOSED 35 U.S.C. § 112, 1st PARAGRAPH REJECTIONS
Enablement
Regarding claim 1 and 20, Requester argues that the ’614 Patent is not
enabled for a device comprising a “drug [or therapeutic agent] . . . in an
amount to provide therapy for a period of several weeks to about 6 months.”
Req. App. Br. 37–38. In particular, Requester argues that the only example
in the ’614 Patent is for albumin and is not shown to be enabled for “about 6
months.” Id. at 38.
Indeed, the albumin example of the ’614 Patent has not been
identified as a drug, and the ’614 Patent only exemplifies an albumin release
profile for up to 50 days. ’614 Patent, Example 2, col. 11–13, particularly
col. 13, ll. 4–5 and Figure 7.
To be enabling, the specification of a patent must teach those skilled
in the art how to make and use the full scope of the claimed invention
without “undue experimentation.” Genentech, Inc. v. Novo Nordisk A/S, 108
F.3d 1361, 1365 (Fed. Cir. 1997). However, the inventor need not include in
the specification that which is already known and available to one of
ordinary skill in the art. See In re Howarth, 654 F.2d 103, 105, (CCPA
1981) (“An inventor need not, however, explain every detail since he is
speaking to those skilled in the art.”).
Enablement is a legal question based on underlying factual
determinations. See Transocean Offshore Deepwater Drilling, Inc. v.
Maersk Drilling USA, Inc., 699 F.3d 1340, 1355 (Fed. Cir. 2012). A claim is
sufficiently enabled even if “a considerable amount of experimentation” is
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necessary, so long as the experimentation “is merely routine, or if the
specification in question provides a reasonable amount of guidance with
respect to the direction in which the experimentation should proceed.” In re
Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). In determining whether
experimentation is undue, In re Wands identifies a number of factors to
consider. Id.
Requester has not provided a detailed analysis of the Wands factors to
demonstrate making and using the claimed invention would require undue
experimentation. See Req. App. Br. 37–38.
Based on the ’614 Patent, we agree with the Examiner that the skilled
artisan would have been capable of making the device of claim 1 and using
the method of claim 20 without undue experimentation. RAN 47–48.
Indeed the ’614 Patent describes how to make the nanopore membrane of
the device of claim 1 and the method of claim 20 and to produce pore sizes
in the range of 4–100 nm. See ’614 Patent, col. 7, l. 3 to col. 8, l. 2. The
’614 Patent also describes a preferred reservoir volume of 250 µl to several
millimeters. Id. col. 5, ll. 35–38.
As discussed above, the Examiner further found that
The potency of drugs approved by the FDA is public
information. The knowledge of the potency of a drug combined
with its molecular dimensions (Stokes diameter) would permit
the person of skill in the art to determine if sufficient drug
could be loaded into the reservoir of the device in order to
provide therapy for several weeks to about six months. Given
this information, it would not require undue experimentation to
practice the full scope of the invention.
RAN 48. We agree that the skilled artisan would have been capable of
providing a drug, such as those described in the ’614 Patent (col. 1, ll. 28–37
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and col.6, ll. 1–15), in an amount and in a potency, i.e., concentration (see
id., col. 4, ll. 41–46), such that the sustained release continued beyond the 50
days demonstrated for albumin. The teaching in the ’614 Patent of the ratio
of drug size to membrane size provides for the zero-order release rate
without undue experimentation. See id., col. 6, l. 55–col. 7, ll. 2.
Accordingly, we affirm the Examiner’s non-adoption of the proposed
rejections under 35 U.S.C. § 112, first paragraph, for lack of enablement.
Written Descriptive Support
Regarding claim 1 and 20, Requester argues that the ’614 Patent lacks
written descriptive support for the phrase “molecular dimensions” as being
broader than the identification of “molecular dimensions” as equating to the
“Stokes diameter” in the ’614 Patent. Req. App. Br. 38.
The Examiner rejected the prior version of claims 1 and 30 because
the claim recited a “molecular diameter” (Action Closing Prosecution 6,
mailed September 26, 2014), but found that the amendment changing
“molecular diameter” to “molecular dimensions” overcame the 35 U.S.C.
§ 112, first paragraph, rejection. See RAN 22. Patent Owner contends that
Requester’s proposed rejection is untimely, being argued after the
Examiner’s withdrawal of the rejection in the RAN. PO Reb. Br. 18.
Indeed, the Requester did not propose such a rejection in their Comments
after Patent Owner’s amendment, and did not even appear to acknowledge
this particular claim amendment. See generally Requester’s Comments after
the Action Closing Prosecution, filed November 5, 2014).
Moreover, it does not appear that Patent Owner is proposing or that
the Examiner is considering the term “molecular dimensions” as having a
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scope outside of the scope afforded by the written description. The ’614
Patent expressly uses the term “molecular dimensions” of the drug. See col.
2, ll. 48–49 (“precisely tailoring the pores of the membrane to the molecular
dimensions of the drug”). The ’614 Patent further uses the Stoke’s diameter
as characterizing the “molecular dimensions” of a drug. Col. 6, ll. 57–61
(“precisely fabricating pores with dimensions that are selected to range from
a size similar to that of the drug molecule to several times the size of the
drug, (e.g., approximating 1 to 5 times the Stoke’s diameter of a drug
molecule).” The “Stoke’s diameter” or “Stoke’s radius” is a recognized way
to provide a spherical approximation of a molecule based on its experimental
hydrodynamic behavior.20 Stoke’s radius for a variety of drugs is known in
the art. Alternatively, the Stoke’s radius is a property that can be determined
experimentally using techniques well-known in the art. Thus, with respect to
the claims, it is reasonable to interpret the phrase “1–5 times the molecular
dimensions of the drug” as 1 to 5 times the Stoke’s diameter of a particular
drug, based on the express description in the ’614 Patent.
Requester also argues that the phrase “whereby the release kinetics
provide a substantially constant therapeutic level” as recited in claim 20
lacks written descriptive support in the ’614 Patent. Req. App. Br. 39. For
support of this amendment, the Examiner and Patent Owner rely on col. 4, ll.
41–42 and Figures 7 and 9 of the ’614 Patent. PO Reb. Br. 18; RAN 24–26.

20 See e.g.,
http://www.genscript.com/molecular-biology-glossary/2614/Stokes-radius,
as accessed June 24, 2016.
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The ’614 Patent states that “the rate of diffusion is slowed and
controlled at a nearly constant level as a function of pore size.” Col. 2, ll.
55–56. The ’614 Patent further describes: “sustained, constant release of
potent drugs” (col. 4, l. 21), “release the encapsulated drug at a nearly
constant rate to mimic slow infusion” (col. 4, ll. 37–38), “a constant rate of
release of the drug” (col. 7, ll. 1–2), “the expected constant rate of diffusion”
(col. 12, l. 23), “the rate of release of the therapeutic agent is substantially
constant” (col. 13, ll. 61–61). In other words, only the release rate of the
drug or the rate of diffusion is expressly described in the ’614 Patent as
“constant” or “nearly constant.” The ’614 Patent does not state that drug is
provided at a “substantially constant therapeutic level,” as recited in claim
20. We interpret this phrase to mean the levels that are achieved in the body
of the patient, such as in the patient’s blood, are constant and at a level that
provides a therapeutic effect. The ’614 Patent describes that the device is
“designed” such that the “nearly constant rate” of release “mimics slow
infusion, so that the patient will have therapeutic levels of the drug in his/her
body for the entire course of therapy.”
The ’614 Patent sufficiently correlates a nearly constant rate of release
of a drug with a “substantially constant therapeutic level of the therapeutic
agent in the body,” as recited in the claims. Specifically, Figures 7 and 9
show the blood levels of groups of rats after implantation of membrane
devices comprising albumin (Fig. 7) and lysozyme (Fig. 9) based on
specifically designed daily dosages. ’614 Patent, col. 4, ll. 1–6 and 11–15,
and col. 12, l. 59, and col. 13, l. 37–38. The ’614 Patent data “suggest that
physiological equilibrium or steady-state is achieved suggesting that the rate
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of BSA release from the NanoGATE implant is balanced with clearance
from the blood stream” (col. 13, ll. 7–10) and that “blood levels in animals
in the implant group were maintained for a period of several months.” Col.
13, ll. 41–43. Figure 7 and Figure 9 both show a blood concentration of less
than 0.1 µg per day after a first phase of about a 10 day period of “rapid
initial clearance.” Col. 12, l. 61 to col. 13, l. 7, col. 13, ll. 40–44, and
Figures 7 and 9.
This data demonstrate substantially constant levels of an active agent
in the blood for several months. Thus, there is sufficient written descriptive
support to find that these blood stream levels or the daily dosages that
produced these blood stream levels correlate to “substantially constant
therapeutic level” of a drug.
Accordingly, we affirm the Examiner’s non-adoption of proposed
rejections under 35 U.S.C. § 112, first paragraph, for lack of written
descriptive support.

DUE PROCESS CONCERNS
Requester contends that it has been denied due process because the
same Examiner had an ex parte interview with Patent Owner counsel during
prosecution of a related continuation application having an identical
specification and similar claims. Req. App. Br. 40–42. Requester’s
arguments are without merit. Requester had full opportunity to respond to
Patent Owner’s amendments and Patent Owner’s arguments in support of
those amendments, filed March 3, 2014, made during the present inter partes
reexamination, including the opportunity to file additional evidence and to
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propose additional rejections to address the claims as amended by Patent
Owner. See 37 C.F.R. §§ 1.947 and 1.948(a)(2) (requester may file
additional prior art with a comments submission to rebut a response of a
patent owner). Requester took such opportunity and filed comments on
March 27, 2014. Requester also had the opportunity to respond to the
Examiner’s Action Closing Prosecution to the extent Patent Owner files
comments thereafter. See 37 C.F.R. § 1.951(b). Because Patent Owner filed
comments on October 10, 2014, in response to the Action Closing
Prosecution, Requester had the opportunity and, in fact, filed comments on
November 5, 2014.
Requester has demonstrated no grounds that it was denied due process
in this inter partes reexamination.

DECISION
In sum, we affirm the Examiner’s decision not to reject:
Claims 1–3, 6, 10–12, 19, 20, 31, 33, and 34 under 35 U.S.C. § 102(b)
as anticipated by Keller (Rejections 1 and 2);
Claims 4, 5, 8, 9, 13–16, 21, 22, 30, 32, and 35–38 under 35 U.S.C.
§ 103(a) as unpatentable over Keller in view of additional prior art
(Rejections 6–12);
Claims 3, 20, 31, 33, and 34 under 35 U.S.C. § 102(b) as anticipated
by Desai (Rejections 3 and 4);
Claims 1, 9–12, 19, 20, 31, 33, and 34 under 35 U.S.C. § 102(b) as
anticipated by Martin 2001 (Rejection 25);
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Claims 13–16, 21, 22, 30, 32, and 35–38 under 35 U.S.C. § 103(a) as
unpatentable over Martin 2001 in view of additional prior art (Rejections
26–29);
Claims 1–6, 8–16, 19–22 and 30–38 under 35 U.S.C. § 314(a) as
being impermissibly broadened;
Claims 1–6, 10–22 and 30–38 under 35 U.S.C. § 112, first paragraph,
for lack of enablement (Rejection 36); and
Claims 1–6, 8–16, 20–22 and 30–38 under 35 U.S.C. § 112, first
paragraph, for lack of written description (Rejection 34 and 38).

We reverse the Examiner’s decision not to reject the claims as follows
and enter the following new ground of rejection:
Claims 1, 10–16, 19, and 30 under 35 U.S.C. § 102(b) as anticipated
by Desai (Rejections 3 and 4).

We enter the following new grounds of rejections:21
Claims 1, 9, 10–16, 19–22 and 30–34 under 35 U.S.C. § 103(a) as
being unpatentable over Desai alone or further in view of Wong;
Claims 21, 22, 31, and 32 under 35 U.S.C. § 103(a) as being
unpatentable over Desai in view of Haak and/or Wong;
Claims 35 and 36 under 35 U.S.C. § 103(a) as being unpatentable
over Desai in view of Yamagata; and

21 Some new grounds of rejections are encompassed by Rejections 15–19,
but is not a true reversal of the Examiner because our reasoning differs from
that of the Examiner.
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Claims 37 and 38 under 35 U.S.C. § 103(a) as being unpatentable
over Desai in view of Keller and Dunn.

We affirm the Examiner determination not to adopt any rejections of
claims 2, 3, and 7.

NEW GROUND OF REJECTION
37 C.F.R. § 41.77(b) states:
(b) Should the Board reverse the examiner’s determination not
to make a rejection proposed by a requester, the Board shall set
forth in the opinion in support of its decision a new ground of
rejection; or should the Board have knowledge of any grounds
not raised in the appeal for rejecting any pending claim, it may
include in its opinion a statement to that effect with its reasons
for so holding, which statement shall constitute a new ground of
rejection of the claim. Any decision which includes a new
ground of rejection pursuant to this paragraph shall not be
considered final for judicial review. When the Board makes a
new ground of rejection, the owner, within one month from the
date of the decision, must exercise one of the following two
options with respect to the new ground of rejection to avoid
termination of the appeal proceeding as to the rejected claim:

(1) Reopen prosecution. The owner may file a response
requesting reopening of prosecution before the examiner. Such
a response must be either an amendment of the claims so
rejected or new evidence relating to the claims so rejected, or
both.

(2) Request rehearing. The owner may request that the
proceeding be reheard under § 41.79 by the Board upon the
same record. The request for rehearing must address any new
ground of rejection and state with particularity the points
believed to have been misapprehended or overlooked in
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entering the new ground of rejection and also state all other
grounds upon which rehearing is sought.

Requests for extensions of time in this inter partes reexamination
proceeding are governed by 37 C.F.R. § 1.956. See 37 C.F.R. § 41.79.

AFFIRMED-IN-PART; NEW GROUNDS OF REJECTION

FREDMAN, Administrative Patent Judge, dissenting-in-part.

While I concur with the Majority’s decision affirming the Examiner
under 35 U.S.C. § 102(b), § 103(a), § 314(a), § 112, first paragraph
enablement and written description, and I further concur with the New
Grounds of Rejection under § 103(a), I respectfully dissent from the
Majority’s reversal of the Examiner’s decision not to reject the claims under
35 U.S.C. § 102(b) as anticipated by Desai and consequent New Grounds of
Rejection.
I begin with claim construction, because this is the essence of my
disagreement with the Majority, and fundamental to properly applying the
prior art of Desai. Claim 1 is drawn to a “drug delivery device” that
comprises three elements: “a capsule” that comprises a reservoir; “a drug”
that is contained in the reservoir “in an amount to provide therapy for a
period of several weeks to about 6 months”; and “a nanopore membrane”
that controls release of the drug from the reservoir.
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As I interpret claim 1, the requirement for “a drug . . . in an amount to
provide therapy for a period of several weeks to about 6 months” is not
intended use, but rather is a structural limitation of the claim. And while the
drug is in a capsule reservoir and is released through a nanopore membrane,
the reservoir and membrane do not “act” on the drug but rather contain the
drug or permit release of the drug. “[C]laims are interpreted with an eye
toward giving effect to all terms in the claim.” Bicon, Inc. v. Straumann
Co., 441 F.3d 945, 950 (Fed. Cir. 2006).
Unlike Schreiber, relied upon by the Majority, where any conical
device with an appropriate size opening may function to dispense popcorn,
the structure of conical devices that actually contain either popcorn or motor
oil differ. The average cinema buff might be dismayed to find motor oil in
their snack or popcorn in the oil can used to fill their car’s engine. Similarly,
the device of claim 1 structurally differs based on the presence of a drug or
water, or of insulin or warfarin, as well as the amount of that drug.
While the use of a drug or of any particular drug in particular amounts
may be obvious (and I concur with the Majority’s obviousness analysis – see
footnotes 11 and 13, supra), a claim requiring “a drug . . . in an amount to
provide therapy for a period of several weeks to about 6 months” requires
the presence of the drug in certain amounts, and does not merely recite
“materials upon which the components of the structure work.” See In re
Ruskin, 347 F.2d 843, 846 (CCPA 1965) (“It is important to note that
appellant’s claims are drawn to specific structure, rather than being in a
broad ‘means for’ form. It is such latter type of claim which may be
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anticipated by an apparatus whose structure, though different, achieves the
same result.”)
I agree with the Examiner that “Desai does not contemplate or even
suggest [a] device with an amount of drug (e.g., IgG) that provides therapy
for a period of several weeks to about 6 months when released at a zero-
order rate, as claimed” (Ex. Ans. 15–16).
Therefore, because Desai does not teach a device that comprises “a
drug . . . in an amount to provide therapy for a period of several weeks to
about 6 months,” Desai does not anticipate the claims.
For these reasons, I would affirm the Examiner’s determination not to
reject the claims under 35 U.S.C. § 102(b) as anticipated by Desai, and
therefore I dissent from this portion of the Majority’s Decision.

PATENT OWNER:
McDermott Will & Emery LLP
500 North Capitol Street NW
Washington, DC 20001

THIRD-PARTY REQUESTER:
ALEXANDER R. TRIMBLE
KILPATRICK, TOWNSEND & STOCKTON LLP
ONE EMBARCADERO CENTER, 8 TH FLOOR
SAN FRANCISCO, CA 94111-3834