Ex Parte 7955614 et al

Patent Trial and Appeal Board

Sep 28, 2018

95002099 (P.T.A.B. Sep. 28, 2018)

UNITED STATES PATENT AND TRADEMARKOFFICE
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 09/27/2018
McDermott Will & Emery LLP
500 North Capitol Street NW
Washington, DC 20001
EXAMINER
WITZ, JEAN C
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
09/27/2018 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 2018-003281
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.

FINAL DECISION ON APPEAL UNDER 37 C.F.R. § 41.77(f)

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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.
On August 9, 2016, the Patent Trial and Appeal Board issued a
Decision on Appeal (“Decision”). The Decision included the following new
grounds rejecting claims 1, 4-6, 8-16, 19-22, and 30-38 of the ’614 patent
(Decision 43-44):
Claims 1, 10-16, 19, and 30 under 35 U.S.C. § 102(b) as anticipated
by Desai;1
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;2

1 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”).
2 WO 01/30323 A2, published May 3, 2001, and naming Vernon G. Wong,
et al. as inventors (“Wong”).
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Claims 4-6, and 83 under 35 U.S.C. § 103(a) as being unpatentable
over Desai in view of Atkinson;4
Claims 21, 22, 31, and 32 under 35 U.S.C. § 103(a) as being
unpatentable over Desai in view of Haak5 and/or Wong;
Claims 35 and 36 under 35 U.S.C. § 103(a) as being unpatentable
over Desai in view of Yamagata;6 and
Claims 37 and 38 under 35 U.S.C. § 103(a) as being unpatentable
over Desai in view of Keller7 and Dunn.8 See Decision 43-44.
Because the Decision included new grounds of rejection, Patent
Owner was provided with two options under 37 C.F.R. §41.77(b): (1) to file

3 The rationale behind the rejection of claims 4-6 and 8 was discussed in the
Decision (see Decision 30-31). However, the actual rejection was
inadvertently left off the list of rejections both in the Summary of New
Grounds based on Obviousness (see Decision 33) and in the listing of
rejections at the end of the Decision (see Decision 43-44). Because Patent
Owner acknowledges the rationale behind the rejection and presents
arguments in response thereto (PO Request i (Table of Contents), 5 (listing
of rejections), 30-31; PO Comments 1-2, 22-23; PO Reply 9, 13), which are
addressed below, and the Examiner and Requester, in turn, acknowledge and
addresses Patent Owner’s arguments (Determination 3, n. 1, 24-26, 45; Req.
Comments 17-18; Req. Reply 19)), we determine that Patent Owner had
sufficient notice of the rejection and adequate opportunity to respond
thereto, such that our maintenance of a rejection of claims 4-6 and 8 based
on Atkinson does not constitute a new ground of rejection of these claims.
4 U.S. Patent 5,443,461, issued August 22, 1995, to Linda E. Atkinson et al.
(“Atkinson”).
5 U.S. 5,158,537, issued October 27, 1992 to Ronald P. Haak, et al. (“Haak”).
6 U.S. 5,628,993, issued May 13, 1997, to Yutaka Yamagata et al.
(“Yamagata”).
7 WO 95/24472, published September 14, 1995, naming Christopher G. Keller,
et al., as inventors (“Keller”).
8 U.S. Patent 5,888,533, issued March 30, 1999, to Richard L. Dunn (“Dunn”).
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a response requesting reopening of prosecution before the examiner; OR (2)
request that the proceeding be reheard before the Board upon the same
record. Decision 44-45.
Patent Owner timely filed a rule-compliant response requesting
reopening of prosecution under 37 C.F.R. §41.77(b)(1). Request to Reopen
Prosecution, filed December 15, 2016 (“PO Request”). Patent Owner’s
Request included amendments to claims 1 and 20 and new evidence in the
form of Declarations of Dr. Frances J. Martin (“2nd Martin Decl.”)9 and Dr.
Phyllis Gardner (“Gardner Decl.”) and exhibits thereto.
Third Party Requester, Nano Precision Medical (“Requester”), filed
Comments under 37 C.F.R. § 41.77(c) in response to the Patent Owner’s
Request on January 13, 2017, with additional evidence in the form of the
Declaration of Dr. Tejal A. Desai and exhibits thereto (“2nd Desai Decl.”).10
The Board entered an Order on April 20, 2017, entering the
amendments to claims 1 and 20 and remanding the case back to the
Examiner for a determination under 37 C.F.R. § 41.77(d), which was mailed
September 1, 2017 (“Determination”).
In the Determination, the Examiner determined that
claims 1, 10-16, 19, and 30 are not anticipated by Desai under 35
U.S.C. §102(b),
claims 1, 4-6, 8-16, 19, and 30 are obvious over Desai alone or in
view of Wong or Atkinson under 35 U.S.C. §103(a), and

9 We also acknowledge Dr. Martin’s Declaration of December 15, 2016 (“1st
Martin Decl.”), previously of record.
10 We also recognize Dr. Desai’s earlier Declaration of October 24, 2014
(“1st Desai Decl.”), previously of record.
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claims 20-22 and 31-38 are not obvious over Desai alone or in view of
Wong.
Determination 44-45.
Requester submitted Comments under 37 C.F.R. § 41.77(e) on
September 29, 2017 (“Req. Comments”). Patent Owner submitted
Comments under 37 C.F.R. § 41.77(e) on October 2, 2017 (“PO
Comments”). In response to thereto, respectively, Patent Owner submitted a
reply under 37 C.F.R. § 41.77(e) on October 27, 2017 (“PO Reply”), and
Requester submitted a reply under 41.77(e) on October 31, 2017 (“Req.
Reply”). Jurisdiction now returns to the Board for reconsideration and a
final decision under 37 C.F.R. § 41.77(f).
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 and italics representing amendments to the claims made by Patent
Owner in the Request filed after our Decision):
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;
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] seated on
said port to separate the reservoir from an environment
external to the device, 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]
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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.
PO Request 2, 5, Claims App’x (paragraph breaks also added for clarity).

Claim Interpretation
We do not alter our claim interpretation set forth in the Decision,
particularly that, with respect to claim 1, the presence of the drug itself does
not patentably distinguish a drug delivery device having an identical
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structure that is otherwise capable of containing such a drug within its
reservoir. See Decision 6-10.
Claim 1 has been newly amended to further recite that the nanopore
membrane is “seated on said port to separate the reservoir from an
environment external to the device.” We note that claim 1 requires that the
device be a capsule featuring no more than (1) a wall defining a reservoir
and comprising a port and (2) a nanopore membrane seated on said port. A
prior art apparatus reading on this device need not have more than these
features.

Anticipation based on Desai
Claim 1
Claim 1 stands rejected under 35 U.S.C. § 102(b) as anticipated by
Figure 5 of Desai.11 Decision 11-15. Claim 1 is directed to a drug delivery
device comprising a capsule with a fluid impermeable wall defining a
reservoir comprising at least one port and a nanopore membrane. The newly
amended claim 1 adds that the nanopore membrane is “seated on said port to
separate the reservoir from an environment external to the device.”
The Patent Owner argues that Figure 5 of Desai, reproduced below,
does not teach the nanopore membrane is seated to separate the reservoir
from an environment external to the device. PO Request 11-12.

11 Because the new ground of rejection relies on the teachings of Figure 5 of
Desai, we decline to opine on arguments by either party directed to Figure 2
of Desai. Similarly, as there are no pending rejections based on Keller
before the Board, we decline to opine regarding the teachings of Keller.
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Figure 5 depicts a schematic view of a rotating diffusion chamber
used to test microfabricated membranes comprising two 2 mL chambers,
Compartments A and B, each having sampling injection ports and separated
by a microfabricated membrane array. Desai 226, Figure 5, caption and 224,
col. 2, last full ¶.
The Examiner finds that the “device” of Figure 5 of Desai constitutes
both Compartment A and Compartment B and, accordingly, the nanopore
membrane separating the two compartments does not separate the reservoir
from an environment external to the device as required by the claim. For
this reason, the Examiner agrees with Patent Owner and determined that
claim 1 is not anticipated by Desai.
We cannot agree with the Examiner’s findings, which are not
consistent with the requirements of a device according to the language of the
claim. Rather, the device claims read directly on Compartment A (i.e., a
capsule comprising a wall defining a reservoir and comprising a port) and
the nanopore membrane, as found in the Decision. Decision 13. Indeed, the
Decision identifies Compartment A as being a reservoir having a volume of
2 mL and a port, which, along with the nanopore membrane, “meets all the
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structural limitations of the claimed drug delivery device.” Id. Thus,
Compartment B itself constitutes an environment exterior to the device, so
much as the “device” is defined by the language of the claim, requiring only
a reservoir and a membrane seated on a port thereof.
Patent Owner argues that the membrane of Figure 5 of Desai is not
seated on Compartment A but rather Compartment A and Compartment B
are separated by the membrane, sealed with o-rings, and screwed together.
PO Comments 16-20; PO Reply 9. We are not persuaded by this argument
because Compartment B constitutes an environment outside of the device as
recited in the claims. The phrase “seated on” does not preclude the structure
described in Figure 5, with or without the presence of Compartment B.
Indeed, the claim recites no structural requirement as to how the membrane
is seated on a port but rather, structurally, requires no more than a membrane
being disposed adjacent the port.
The Patent Owner contends that the device of Figure 5 of Desai is
designed to test the diffusion of the substance in Compartment A through the
nanopore membrane by collecting and testing the substance in Compartment
B. PO Comments 7. The Patent Owner points to the declaration of Dr.
Martin, who duplicated the device of Desai, to show that when the device is
thrown into water, none of the substance of Compartment A diffuses into the
water, only into Compartment B. PO Request 20-21 (citing 2nd Martin Decl.
¶¶ 10-17). This argument does not change or address our analysis that
Compartment B constitutes an environment outside of the device, as the
device as recited in claim 1 reads directly on the structure of Compartment A
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and the nanopore membrane. The claim does not structurally require that the
“external environment” be a body in which the device is implanted.
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). We have found Compartment A plus the
attached membrane includes all of the structural features recited in the
claims and further find that the Desai Compartment A and membrane would
have been capable of being implanted, as the volume (2 mL) is consistent
with the sizes described for insertion in the ’614 Patent (col. 5, ll. 35-38),
and, with such finding, shift the burden to Patent Owner to show that
Compartment A and the membrane would not have been capable of
functioning as an implantable drug delivery device. Decision 13-14.
Patent Owner argues that the testing device of Figure 5 in Desai is
meant to rotate and is, therefore, not capable of being used as an implantable
device. PO Comments 16. Patent Owner’s argument is not persuasive
because all of the structural requirements recited in the claim are met. The
device of Figure 5 is rotated when used for in vitro testing “to ensure
adequate mixing of the solutions throughout the course of the diffusion
experiment.” Desai 224, col. 2, last full ¶. Patent Owner has not explained
why such rotation would be necessary were the same device (Compartment
A and the membrane) used as an implantable drug delivery device.
Patent Owner presents no separate arguments for any of claims 10-16,
19 or 30 apart from the arguments addressing claim 1. See PO Request 12.
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Accordingly, we maintain our rejection of claims 1, 10-16, 19, and 30 under
35 U.S.C. § 102(b) as anticipated by Desai.

Obviousness based on Desai
Claim 1 – Desai alone or further in view of Wong
The Decision relied both on Figure 5 of Desai and, alternatively, on
modifying Figure 2 of Desai to have a larger volume, such as taught by the
alternative structure Figure 5 of Desai or Wong. Decision 19-20. For the
reasons discussed above, we maintain the rejection with respect to Figure 5
without modification of the device. After all, it is well established that lack
of novelty is the ultimate or epitome of obviousness. In re Fracalossi, 681
F.2d 792, 794 (CCPA 1982) (“Though the composition might have been
obvious, though not anticipated, it cannot have been anticipated and not have
been obvious. Thus evidence establishing lack of all novelty in the claimed
invention necessarily evidences obviousness.”).
Further, the Examiner determined that it would have been obvious to
modify the device of Figure 5 so that Compartment B is not present because
it is not necessary. Determination 10, 16. Without Compartment B, the
nanopore membrane separates the compartment carrying the reservoir with
an environment external to the device, even under Patent Owner’s more
narrow proposed interpretation of the teachings of the art vis-à-vis the
claims. Id. We agree with the Examiner that this modification would have
been obvious to one of ordinary skill in the art particularly because, as
explained below, Desai teaches alternative ways of collecting material that
crosses the membrane barrier.
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Patent Owner argues that the device of Desai was intended for testing
and without the addition of Compartment B would defeat the intended
purpose of the device. PO Request 20; PO Comment 7; PO Reply 10. We
do not find this argument persuasive. Desai teaches alternative methods of
collecting and analyzing material from a device other than collection via an
attached compartment. Indeed, Desai teaches exposing a capsule comprising
polystyrene beads to “the medium surrounding the biocapsules” wherein the
medium was “collected and bead concentration was measured using a
spectrofluorimeter.” Desai 224, ¶ spanning cols. 1-2.12 Thus, the skilled
artisan would have recognized that diffusion of material from Compartment
A through the membrane could be similarly tested by measuring the amount
of material in a medium surrounding a device that simply includes
Compartment A and a membrane, without the presence of Compartment B.
Thus, without Compartment B, the device is capable of being used both as
an implantable device and as a nanopore testing device.
Patent Owner argues that because the membrane is positioned
between Compartment A and Compartment B, sealed with o-rings, and
screwed together, that Desai does not teach or suggest removal of
Compartment B and provides no direction on how to secure the nanopore
membrane without Compartment B. PO Request 31; PO Comments 16-20.
This argument is not persuasive.

12 Dr. Martin used a substantially identical method to measure the presence,
or lack thereof, of material in a surrounding medium in his declaration. 2nd
Martin Decl. ¶ 13.
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First, Desai is generally directed to implantable biodelivery devices.
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.”). Thus, the skilled artisan would consider using the
device recited in the claims, i.e., Compartment A and the membrane, without
the need for Compartment B for collecting diffused material.
Second, as discussed, the claim recites no structural requirement as to
how the membrane is seated on a port, but rather, structurally, requires no
more than a membrane being disposed adjacent the port.
Finally, Patent Owner’s argument does not consider the skill of the
ordinary artisan in attaching a membrane to a reservoir. Indeed, Desai
suggest that the membrane can be attached via screws and sufficient sealing
(via o-rings). Thus, if Compartment B were removed to permit the material
that crosses the membrane to be collected by an alternative means, such as in
a larger vessel, one of ordinary skill in the art would have known how to
attach the membrane to Compartment A.
There is no evidence to suggest the skilled artisan would not have
known how to attach a membrane directly to Compartment A without the
presence of Compartment B. Indeed, the ’614 patent provides no particular
guidance to the skilled artisan on how to seat a membrane on a port, thus, it
is presumed that the skilled artisan is aware of suitable techniques for doing
so. 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.”
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KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). “A person of ordinary
skill is also a person of ordinary creativity, not an automaton.” Id. at 421.
Patent Owner further argues that the device of Figure 5 is described to
be used while being rotated, and that this requirement would render the
device unsatisfactory for implantation into the body. We disagree. As
discussed above, Desai does not teach that the device must be rotated when
implanted, only that it must be rotated for use in testing “to ensure adequate
mixing of the solutions throughout the course of the diffusion experiments.”
Desai 224, col. 2, last full ¶. Patent Owner has not explained why such
rotation would be necessary were the same device (Compartment A and the
membrane) used as an implantable drug delivery device. Once again,
because Desai teaches a device (Compartment A and the membrane) that is
identical to the device recited in the claims (i.e., a reservoir plus a
membranes seated on a port thereof), the burden shifts to Patent Owner to
show that the structure would not be capable of functioning as recited in the
claims. In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
In light of these findings and determinations set forth above with
respect to Figure 5 of Desai, we need not address the alternative reasoning
with respect to Figure 2 of Desai in further detail.13
Indeed, all of Patent Owner arguments with respect to dependent
claims 9-16, 19 or 30 are only directed to the Decision’s alternative rejection
of claim 1 based on modifying Figure 2 of Desai to have a larger volume.

13 However, we note the Examiner’s finding that Figure 2 does not teach or
suggest a membrane seated on a port of a reservoir, but rather teaches a
membrane fabricated along with walls of the reservoir in a single structure
from a silicon substrate, a finding with which we agree.
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See PO Request 27-31. Accordingly, we maintain our rejection of claims 1,
9-16, 19, and 30 under 35 U.S.C. § 103(a) as obvious over Desai alone.

Claims 4-6 and 8– Desai in view of Atkinson
With respect to the rejection based on Figure 5 of Desai in view of
Atkinson, Patent Owner presents no argument separate from those made
with respect to claim 1. PO Request 31; PO Comments 22-23; PO Reply 9.
Accordingly, we maintain the rejection of claims 4-6 and 8 for the same
reasons discussed in the Decision. Decision 30-31.

Claim 20 – Desai alone or further in view of Wong
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.
In the Decision, we stated the following:
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-order 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,
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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 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.
Decision 24-25 (footnote omitted).
Patent Owner argues, inter alia, that the step of selecting a ratio of the
pore size of the membrane to the size of the molecular dimensions of the
therapeutic agent recited in the claims results a zero-order release rate,
which is an unexpected deviation from Fickian (concentration dependent)
diffusion that was well recognized in the art. PO Request 45.
Patent Owner presents evidence from Dr. Martin discussing the
unexpected nature of determining that pore size can control release rate and
describing acknowledgment of Martin’s discovery in the field (PO Request
45-47 (citing 2nd Martin Decl. ¶¶ 6, 10-17)), as well as NIH grant funding
awarded to Dr. Martin which, according to Patent Owner, “demonstrates
appreciation of the significance and innovation of the invention by
contemporaries in the field” particularly those in the field “who evaluate the
grant application.” PO Request 47 (citing 2nd Martin Decl. ¶ 7).
Requester relies on the First Declaration of Dr. Desai, the author of
the Desai reference, who testifies that Figures 8 and 9 demonstrate a zero
order release rate that does not follow Fick’s law. Req. Comments 23-24
(citing 1st Desai Decl. ¶¶ 5, 7, 8, 13, 15). Requester does not comment
regarding Patent Owner’s evidence of unexpected results or acclaim. See
generally Req. Comments.
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The Examiner finds that Desai does not teach zero-order release
kinetics (Determination 28), and thus does not teach all the feature recited in
method claim 20. Id. at 44. The Examiner further determines that the pore
size to drug size ratio “is unexpected and has been acclaimed by professional
colleagues in articles,” referencing the grant award to Dr. Martin.
Determination 44 (citing PO Request 46 and 2nd Martin Decl. ¶ 7). The
Examiner adds that “[e]ven Dr. Desai recognized this non-Fickian diffusion
principle by citing to the first Martin et al. paper that disclosed this finding.”
Id. (citing PO Request 46-47).
We agree with the Examiner that Figures 8 and 9 of Desai are not
sufficient evidence that, as the time of the invention, that it would have been
obvious to obtain a zero-order release for a pore size to drug size ratio
falling within the range recited in the claim.
Initially, we agree with Dr. Gardner (see Gardner Decl. ¶ 15),14 that
the actually profiles shown in Figures 8 and 9, reproduced below, are
insufficient to show that linear release profiles were suggested in the
teachings of Desai.

14 Although not directly addressed in our Decision, upon consideration of
this evidence in the first instance, we were similarly not so persuaded by
Requester’s arguments based on the express teachings of Desai.
Nonetheless, we need not have addressed this argument in entering new
grounds on an alternative rationale as recited in the Decision. Decision 24-
25.
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Moreover, there is no evidence of record to support a finding of
recognition in the teachings of Desai that a zero-order release profile could
have been achieved or that a pore size to drug size ratio would lead to such a
release profile. Rather, there is sufficient evidence to establish that Desai
teaches only a Fickian diffusion profile. Gardner Decl. ¶ 18; Desai 228, ¶
spanning cols. 1-2. Dr. Desai’s testimony regarding the profiles shown in
Figures 8 and 9 is based on extrapolating the data beyond the limited time
period of data presented in Desai. 1st Desai Decl. ¶¶ 6-7. We cannot find
this evidence persuasive because it is speculative and not based on the actual
data shown in Desai, but rather on extrapolated data that may or may not be
borne out by actual experiments. Further, even if Dr. Desai is correct that
“Desai clearly shows a zero order rate of release of IgG at all pore sizes,”
Desai does not recognize or attribute any criticality to a particular pore size
to drug size ratio, as recited in the claims.
Moreover, we are persuaded by the evidence of record that, even if it
would have been obvious to optimize a pore size for any given drug as noted
in our Decision, such an optimization does not necessarily lead the skilled
artisan to the pore size to drug size ratio recited in the claims nor is a zero-
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order release rate predictably achieved from such optimization. Indeed,
based on the testimony of Dr. Martin (see Martin Decl. ¶ 6), we are
persuaded that this ratio and its resulting release profile are unexpected over
the art of record, which suggests only Fickian diffusion.
The Examiner further found persuasive Dr. Martins evidence of that
the invention “has been acclaimed by professional colleagues” in the art and
of Dr. Martin’s awarded grant by the National Institutes of Diabetes and
Digestive Kidney Diseases. Determination 44. We do not find the mere
“independent confirmation” of Dr. Martin’s findings to be “acclaim” for Dr.
Martin’s findings, as does the Examiner. However, we agree with the
Examiner that the undisputed testimony of Dr. Martin and the evidence of
record weighs in favor of finding that the skilled artisan would not have
expected diffusion through a porous membrane of Desai to exhibit zero-
order release behavior or the ratio between pore-size and drug-size recited in
the claims.
Thus, while it is undoubtedly true that selection of a membrane pore
size for optimal release rate of any given drug would have been obvious, as
was the fact that for many drugs a zero-order release rate was desirable (see
Decision 24, n.14), the evidence weighs in favor of determining that the ratio
set forth in the claims being the key to achieving a zero-order release rate for
any given drug size was not obvious from the art of record.

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DECISION
In sum, we sustain the rejection of:
Claims 1, 9, 10–16, 19, and 30 under 35 U.S.C. § 102(b) as
anticipated by Desai,
Claims 1, 9, 10-16, 19 and 30 under 35 U.S.C. § 103(a) as being
unpatentable over Desai alone or further in view of Wong; and
Claims 4-6 and 8 under 35 U.S.C. §103(a) over Desai alone or in view
of Wong and further in view of Atkinson.
However, we do not sustain any of the new grounds of rejections of
claims 20-22 and 31-38 under 35 U.S.C. § 103(a).

In the event neither party files a request for rehearing within the time
provided in 37 C.F.R. § 41.79, and this Decision becomes final and
appealable under 37 C.F.R. § 41.81, a party seeking judicial review must
timely serve notice on the Director of the United States Patent and
Trademark Office. See 37 C.F.R. §§ 90.1, 1.983.

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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

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FREDMAN, Administrative Patent Judge, dissenting-in-part.
While I concur with the Majority’s decision to not sustain any of the
new grounds of rejections of claims 20-22 and 31-38 under 35 U.S.C. §
103(a), I respectfully dissent from the Majority’s decision to sustain the
rejection of claims 1, 9, 10–16, 19, and 30 under 35 U.S.C. § 102(b) as
anticipated by Desai and to sustain the rejections of claims 1, 4-6, 8, 9, 10-
16, 19 and 30 under 35 U.S.C. § 103(a) as obvious over Desai alone or
combined with Wong or Atkinson.
Anticipation over Desai
As in my earlier dissent, 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 is “seated on” a port of the capsule wall, functions to
“separate the reservoir from an environment external to the device” and
controls release of the drug from the reservoir.
“a drug contained in the reservoir”
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
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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 if the popcorn or motor oil is actually in the device. 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.
As applied to the anticipation rejection of Desai, Desai does not teach
the presence of the drug as required. As the Examiner correctly noted
“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). I
find that for this reason, Desai does not anticipate claim 1.
I also note that because Desai does not contain any drug, Desai does
not, and indeed cannot, inherently teach a “membrane having pores with a
pore size (i) between 2-100 nm and (ii) 1-5 times the molecular dimensions
of the drug” as required by claim 1. Even if Desai teaches pores of the
correct pore size, Desai does not teach a device contains drugs with the
proper dimensional relationship. “Inherency . . . may not be established by
probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l.
Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).
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“membrane . . . to separate the reservoir from an environment
external to the device”
I also interpret the “nanopore membrane” in claim 1 that separates the
“reservoir from an environment external to the device” as requiring that the
membrane must function to release the drug into the environment, not into
another chamber within the device itself.
Figure 5 of Desai is reproduced below:

Figure 5 depicts a device that consists 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” (Desai 224, col. 2). Desai does not
teach a device with a membrane that functions “to separate the reservoir
from an environment external to the device” as required by claim 1.
I therefore disagree with the Majority’s interpretation reliance on
Figure 5 of Desai, finding that “[c]ompartment B constitutes an environment
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outside of the device as recited in the claims.” (see Decision supra). Instead,
I agree with the Examiner that
Neither the device of Fig. 2 nor Fig. 5 of Desai anticipates
instant claim 1. In the device of Fig. 2, the nanopore membrane
separates the reservoir from an environment external to the
device but the nanopore membrane is not seated on the port,
rather the membrane has been cut directly into the biocapsule
wall. The device of Fig. 5 does not anticipate instant claim 1
because the nanopore membrane fails to separate the reservoir
from an environment external to the device.
(Examiner’s Determination 9/1/17 at 4).
I conclude this device is structurally different than that required by
claim 1 because compartment B is reasonably understood as part of the
device and not “an environment external to the device” as required by claim
1 for the physical location of the membrane.
For these reasons, I would not sustain the rejection of claims 1, 9, 10–
16, 19, and 30 under 35 U.S.C. § 102(b) as anticipated by Desai.
Obviousness over Desai, Wong, or Atkinson
I find the claims nonobvious because I find that Desai does not teach a
device that contains both drug and nanopore membrane with the “membrane
having pores with a pore size (i) between 2-100 nm and (ii) 1-5 times the
molecular dimensions of the drug” as required by claim 1.
I disagree with the Majority’s finding obviousness as the epitome of
anticipation for the reasons already given. Instead, I review the record to
determine whether there is evidence of a suggestion or at least some reason to
modify Desai to obtain a device that addresses the nanopore membrane
limitation that renders the claim obvious. I conclude that no obviousness
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rationale has been established and that the evidence of record does not support
a finding an obviousness finding.
I am not persuaded by the Examiner’s reasoning that:
A person of ordinary skill in the art would have found it obvious
to slightly modify compartment A of the mini-diffusion device of
Fig. 5 in Desai in order to seat the nanopore membrane fully
without the necessity of screwing compartments A and B together
for the purpose of creating a drug delivery device where both the
reservoir volume and the pore size of the microfabricated
nanopore membrane can be adjusted to allow for proper delivery
of a specific drug.
(Examiner’s Determination 9/1/17 at 10). The Examiner states a conclusion,
but provides neither evidentiary basis nor persuasive reasoning why the
proposed modification to Desai would have been made. Nor am I persuaded
by Requester’s argument that “it would not require ‘a leap of inventiveness’ to
combine FIG. 2 and FIG. 5 to arrive at the predictable solution” (Requester
Comment 9/29/2017 at 12). For an obviousness rejection, there must be “a
reason that would have prompted a person of ordinary skill in the relevant
field to combine the elements in the way the claimed new invention does.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Neither the
Examiner, Requester, nor the Majority provide a reason I find persuasive to
modify the device of Figure 5 of Desai to remove compartment B so that the
device might then be implantable and to obtain the specific ratio between the
membrane pore size and molecular dimensions of the drug.
I also conclude that the evidence currently of record does not support an
obviousness finding. The device of Desai was designed “to immunoprotect
transplanted pancreatic islets by hindering the passage of IgG molecules while
permitting the passage of glucose and insulin” (Desai 230, col. 1). While an
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ordinary artisan may have found it obvious to use Desai’s device for
implantation into the body, Desai never suggests, contemplates or provides
reasons for replacing the pancreatic islet cells with a drug, much less a
particular relationship between the pore size and the molecular dimensions of
the drug.
I recognize that Wong teaches a drug delivery device with controlled
release of drugs including zero order kinetics (see Wong 4:18–21) for periods
of weeks to years (see Wong 11:31 to 12:1). However, there is no indication
that Wong ever contemplates the use of a nanopore membrane for zero order
kinetic release of drug, instead using an orifice (i.e. opening) in an outer layer
of the device (see Wong 18:1–31). Even if an opening was deemed a known
equivalent to a membrane, an equivalence for which there is no evidentiary
support, there is no evidence establishing that Desai or Wong suggest the
relationship of a “membrane having pores with a pore size (i) between 2-100
nm and (ii) 1-5 times the molecular dimensions of the drug” as required by
claim 1.
I also am not persuaded by the Requester’s reliance on the Desai
Declaration which, at best, suggests the use of Desai’s device for drug delivery
but provides no basis to select the particular relationship between membrane
pore size and molecular dimensions of the drug recited in claim 1 (see, e.g.,
Desai Decl. ¶ 8). I also note that Atkinson is not relied upon for these features.
For these reasons, I would not sustain the rejection of claims 1, 9, 10–
16, 19, and 30 under 35 U.S.C. § 103(a) as obvious over Desai alone or
combined with Wong and Atkinson.
I do concur with the Majority’s decision to not sustain any of the new
grounds of rejections of claims 20-22 and 31-38 under 35 U.S.C. § 103(a).