Dewan Fazlul Hoque. Chowdhury

Patent Trials and Appeals Board

Jul 17, 2019

11566721 - (D) (P.T.A.B. Jul. 17, 2019)

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.
11/566,721 12/05/2006 Dewan Fazlul Hoque Chowdhury C7706/40621 6482
127269 7590 07/17/2019
McCracken & Gillen LLC
1315 West 22nd Street, Suite 225
Oak Brook, IL 60523
EXAMINER
GHALI, ISIS A D
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
07/17/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docket@mfgip.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DEWAN FAZLUL HOQUE CHOWDHURY
____________

Appeal 2018-001186
Application 11/566,721
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal1, 2 under 35 U.S.C. § 134 involving claims to a
transdermal drug delivery device. The Examiner rejected the claims failing
to comply with the written description requirement, as obvious, and on the
grounds of obviousness-type double patenting. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.

1 Appellant identifies the Real Party in Interest as the inventor, Dewan
Fazlul Hoque Chowdhury (see App. Br. 2).
2 We have considered the Specification of Dec. 5, 2006 (“Spec.”); Non-Final
Office Action of June 29, 2016 (“Final Act.”); Appeal Brief of May 30,
2017 (“App. Br.”); and Examiner’s Answer of Aug. 31, 2017 (“Ans.”).
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Statement of the Case
Background
“Delivery of drugs via the transdermal route has several advantages
over more conventional routes such as oral and intravenous or
intramuscular” (Spec. ¶ 4). “The vast majority of marketed transdermal
drug delivery systems are based on the passive diffusion of drug molecules
through the skin. There have been two main approaches to transdermal
systems utilizing passive diffusion, these being the drug-in-adhesive, and the
reservoir system” (Spec. ¶ 5). “Beside the passive methods . . . numerous
active methods for delivering drugs through the skin have been investigated.
These systems can generally be classified into two categories: by-passing or
removal of the stratum corneum, and electrically assisted delivery of drugs”
(Spec. ¶ 16).
The Claims
Claims 1, 3, 5–10, 12–18, and 21 are on appeal. Independent claim 1
is representative and reads as follows:
1. A transdermal drug delivery device comprising:
a reservoir layer, which comprises one or more chambers
for containing a drug, a lower surface of the reservoir layer
being bounded by a resilient membrane perforated by pores
through which the drug may be delivered from the chambers;
and
extensor means, which actuates on receipt of a control
stimulus to deform the reservoir layer by extending it from a
first state to a second state, whereby, as a result of the extension
of the reservoir layer, the pores are enlarged in the second state
compared with the first state and the volume of the chambers in
the second state is less than the volume of the chambers in the
first state, resulting in pressurized chambers when the device is
actuated; and
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an adhesive layer suitable for adhering the device to the
skin of a patient, the adhesive layer configured such that that
deformation of the reservoir layer by the extensor means
deforms the adhesive layer.

The Issues
A. The Examiner rejected claims 1, 3, 5–10, 12–18, and 21 on the
ground of nonstatutory double patenting as being unpatentable over
claims 1–12 of U.S. Patent No. 8,758,311 (Non-Final Act. 6).
B. The Examiner rejected claims 1, 3, 5–10, 12–18, and 21 under
35 U.S.C. § 112, first paragraph as failing to comply with the written
description requirement (Non-Final Act. 7–12).
C. The Examiner rejected claims 1, 3, 5–7, 9, 10, 12–18, and 21
under 35 U.S.C. § 103(a) as obvious over Prausnitz3 (Non-Final Act.
13–17).
D. The Examiner rejected claim 8 under 35 U.S.C. § 103(a) as
obvious over Prausnitz and Gardeniers4 (Non-Final Act. 18–19).

A. Obviousness-type double patenting
Appellant “does not believe a terminal disclaimer is necessary
because the claims, if allowed, would not improperly extend the ‘right to
exclude’ already granted in U.S. Patent No. 8,758,311 (filed August 1,
2011)” (App. Br. 4).
The Examiner responds “the claims of the issued patent and the

3 Prausnitz et al., US 6,611,707 B1, issued Aug. 26, 2003.
4 Gardeniers et al., Silicon Micromachined Hollow Microneedles for
Transdermal Liquid Transport, 12 J. MICROELECTROMECHANICAL SYSTEMS
855–62 (2003).
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instant claims are two-way obvious over each other” and the “rejection will
be maintained” (Ans. 3).
We find that the Examiner has the better position. Appellant does not
dispute the Examiner’s finding that the claims are, in fact, obvious over one
another, but rather contends that because the instant application and US
8,759,311 share a common expiration date, there would be no improper
extension. However, “there is a second justification for obviousness-type
double patenting--harassment by multiple assignees.” In re Fallaux, 564
F.3d 1313, 1318–19 (Fed. Cir. 2009).
We note that the assignee of US 8,758,311 is Nemaura Pharma
Limited and the assignee of the instant application is the inventor, Dewan
Fazlul Hoque Chowdhury. Therefore, the,
harassment justification for obviousness-type double patenting
is particularly pertinent here because the . . . application and the
. . . patent[] are not commonly owned. If the . . . application and
the . . . patent[] were commonly owned, the terminal disclaimer
filed in this case would have been effective to overcome the
double patenting rejection.

Fallaux, 564 F.3d at 1319.
We therefore affirm the obviousness-type double patenting
rejection.

B. 35 U.S.C. § 112, first paragraph
The Examiner finds “claims recite ‘resilient membrane’. The
specification gives no guidance or description to one of ordinary skill in the
art regarding the materials of ‘resilient membrane’” (Non-Final Act 7). The
Examiner finds the “expression ‘resilient membrane’ recited without any
functional/structural correlation does not meet the written description
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requirement for the resilient membrane as one of ordinary skill in the art
could not recognize or understand the resilient membrane from the mere
recitation of its property” (Non-Final Act. 8). The Examiner also finds the
Specification “fails to reasonably convey to one skilled in the art that
applicant was in possession of a representative number of species within that
genus” (Non-Final Act. 11).
Appellant contends the “resilient membrane is described in detail at
least at paragraphs 0030, 0048, 0050, 0053, 0054, 0078, and 0080 of the
specification of the instant application” (App. Br. 5). Appellant contends:
At paragraph 0056, the present application goes on to describe
suitable materials for construction of the chamber 24, of which
the resilient membrane 12 forms the lower surface.
Specifically, example materials for the chamber, and therefore
the resilient membrane, are detailed in this paragraph: “[t]he
material of composition of the reservoir chambers 24 may be
polymeric, e.g. the Eudragit (Registered Trade Mark) range of
pharmaceutical polymers sold by Rohm GmbH, acrylic acid
cross-linked polymers, or PDMS (polydimethylsiloxane).”
(App. Br. 5).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the claims fail to comply with
the written description requirement?
Findings of Fact
1. The Specification teaches a “lower surface of the reservoir layer
is bounded by a resilient membrane. The resilient membrane is perforated
by pores through which the drug may be delivered from the chambers”
(Spec. ¶ 30).
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2. The Specification teaches “the drug is squeezed out of the
chambers in the reservoir layer 10 and through the pores in the resilient
membrane 12” (Spec. ¶ 50).
3. Figure 2 of the Specification is reproduced below:

[0048] The transdermal drug delivery device illustrated
in Figure 2 comprises a reservoir layer 10 that consists of a
series of chambers containing one or more drugs or other
therapeutic molecules in one or more type of formulation. The
reservoir layer 10 is flexible and its lower surface is bounded by
a resilient membrane 12, which is perforated by pores through
which the drug formulation can pass. An adhesive layer 14 is
applied to the membrane 12, which is intended to attach the
device to the skin of a patient. The adhesive layer 14 must be
suitable for removably bonding the membrane 12 to human or
animal skin.
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[0049] A second adhesive layer 16, which may comprise
a different adhesive from the layer 14, bonds an upper surface
of the reservoir layer 10 to an extensor layer 18. In this
embodiment of the invention, the extensor layer 18 is formed as
a microelectromechanical (MEMS) device. A third layer of
adhesive 20, which may be similar to the second layer 16,
bonds the extensor layer to a control layer 22 comprising
microelectronic control circuitry for the extensor layer 18.
Electrical contacts between the extensor layer 18 and the
control layer 22 are indicated schematically by dotted lines 23.
(Spec. ¶¶ 48–49).
4. The Specification teaches “the drug is squeezed out of the
chambers in the reservoir layer 10 and through the pores in the resilient
membrane 12” (Spec. ¶ 50).
5. The Specification teaches “layer 10 is divided into a number of
cuboidal chambers 24, each of which is provided with pores 26 through the
portion of the resilient membrane 12 that forms the lower surface of the
chamber” (Spec. ¶ 53; cf. ¶ 54).
6. The Specification teaches the “material of composition of the
reservoir chambers 24 may be polymeric, e.g. the Eudragit (Registered
Trade Mark) range of pharmaceutical polymers sold by Rohm GmbH,
acrylic acid cross-linked polymers, or PDMS (polydimethylsiloxane)” (Spec.
¶ 56).
7. The Specification teaches “a beneficial feature would be an
increase in the surface roughness of the porous resilient membrane 12, such
that the area of contact with the surface of the skin is increased” (Spec.
¶ 78).
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8. The Specification teaches “the resilient membrane 12 includes
large pores 26 with slightly rigid walls. A thinner, collapsible membrane 36
seals the pores 26 from the chamber 24 containing the drug” (Spec. ¶ 80).
Principles of Law
“[I]t is the specification itself that must demonstrate possession. And
while the description requirement does not demand any particular form of
disclosure, or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1352 (Fed. Cir. 2010) (citations omitted).
Analysis
Claim 1 requires a “resilient membrane perforated by pores” that upon
“receipt of a control stimulus” results in “pores [that] are enlarged.” The
Specification has a number of general descriptions that discuss a resilient
membrane 12 (FF 1–4). However, the Specification clearly distinguishes the
resilient membrane 12 from reservoir layer 10, chamber 24, or membrane 36
(FF 1–4, 7, 8). Indeed, Figure 2 shows a device that comprises seven
different layers that each have different functions such as an adhesive layer
14 that differs from adhesive layer 16, a reservoir layer 10, an extensor layer
18 composed of a MEMs device as well as resilient membrane 12 (FF 3).
And while the Specification does provide a description of specific
materials used in layer 10 to form reservoir chambers 24 (FF 6), the
Specification does not state that these materials are used to form the resilient
membrane 12, nor do any portions of the Specification identified by
Appellant recites any specific materials suitable for resilient membrane 12.
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We therefore agree with the Examiner that the instant “claims merely
recite a description of the problem to be solved while claiming all solutions
to it and . . . cover any compound later actually invented and determined to
fall within the claim’s functional boundaries.” Ariad, 598 F.3d at 1353.
That is, claim 1 recites all possible resilient membranes whose pores are
capable of changing due to extension of another layer while failing to
provide even a single species. The evidence in the Specification clearly fails
to demonstrate a reasonable number of species necessary to demonstrate
descriptive support (FF 1–8).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
claims fail to comply with the written description requirement.

C. & D 35 U.S.C. § 103(a) over Prausnitz or Prausnitz and Gardeniers
The Examiner finds Prausnitz teaches a:
transdermal drug delivery device comprising one or more
reservoir containing a drug and hollow microneedles attached to
a substrate of the skin-facing surface of the reservoir. The
reservoir is made of deformable elastic material. The device
comprises a mean for compressing the reservoir to derive the
drug from the reservoir through the microneedles to the skin.
(Non-Final Act. 14). The Examiner finds that because the microneedles may
be tapered, this “implies that when pressure is applied and the microneedles
penetrates the underlying layers, such as adhesive, the diameters of the pores
of the adhesive will increases as the penetration of the tapered microneedles
is advanced into the skin” (Non-Final Act. 14–15).
The Examiner acknowledges that Prausnitz “does not explicitly teach
extension of the reservoir layer” but finds “it is expected that compression of
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the reservoir to flattened structure could possibly extents the reservoir
laterally” (Non-Final Act. 15).
Appellant contends:
Prausnitz is silent with respect to pores, and the principle of
operation described therein is significantly different from that
of the instant application. Specifically, modifying Prausnitz to
reach the transdermal drug delivery device claimed in the
present application would require changing the principle of
operation for each of the bores, microneedles, reservoir, and
substrate of Prausnitz.
(App. Br. 11). Appellant also contends “Prausnitz does not disclose or
suggest that the substrate may be extended to enlarge the pores” and even
“[a]ssuming, arguendo, that the substrate of Prausnitz does extend, such
extension would still fail to enlarge the alleged pores in Prausnitz because
such pores are formed by the rigid microneedles penetrating the substrate”
(App. Br. 14).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that Prausnitz
alone, or with Gardeniers renders the claims obvious?
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “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).
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Findings of Fact
9. Prausnitz teaches “microneedle devices include at least three
components: at least one, more preferably more, microneedle(s); a substrate
to which the base of the microneedle(s) are secured or integrated; and at
least one reservoir that is selectably in fluid connection with one or more of
the microneedles” (Prausnitz 2:49–53).
10. Figures 1B and 1C of Prausnitz are reproduced below:

The device 10 includes substrate 12 from which a three-
dimensional array of microneedles 14 protrude. As shown, the
annular bore of the microneedles 14 extends through the
substrate 12. The device 10 also includes a reservoir 16 secured
to substrate 12 via a sealing mechanism 18. . . . The device in
FIG. 1b includes a deformable bubble reservoir 16. Manual
pressure can be used to expel its contents at the site application.
FIG. 1c shows a separate reservoir 16 from means 19 for
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expelling the contents of the reservoir 16 at the site of
administration.
(Prausnitz 5:38–51).
11. Prausnitz teaches the “microneedles should have the
mechanical strength to remain intact while being inserted into the biological
barrier . . . In a preferred embodiment, the diameter of the microneedle is
greatest at the base end of the microneedle and tapers to a point at the end
distal the base” (Prausnitz 3:17–30).
12. Prausnitz teaches “delivery of the drug from the reservoir is
initiated by applying a force, such as by pressing reservoir is initiated by
applying a force, such as by pressing the top of the reservoir, to cause the
reservoir contents (i.e. a drug containing composition) to flow out through
the microneedles” (Prausnitz 6:46–50).
Analysis
We agree with Appellant that Prausnitz does not teach a resilient
membrane with pores that may be enlarged upon deformation of the
reservoir layer. While there is no doubt that Prausnitz teaches a microneedle
device with a deformable reservoir that pushes drugs through needles (FF 9–
12), it is equally clear that Prausnitz teaches needles that are reasonably
understood to remain intact and not deform or enlarge when drug is passing
through (FF 11).
The Examiner appears to be relying upon inherency to support the
position that the “diameters of the pores of the adhesive will increases as the
penetration of the tapered microneedles is advanced into the skin” (Ans. 5–
6). However, if the Examiner is relying upon the adhesive as the resilient
membrane, there is no evidence that prior to penetration by the needles, the
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adhesive contains any pores whatsoever and therefore meets the requirement
of claim 1 for a “resilient membrane perforated by pores”.
We also agree with Appellant that the Examiner has not established
with evidence, as opposed to argument, that any holes in the adhesive
present during needle penetration necessarily increase in diameter as the
needle completes penetration. That is, the Examiner’s position depends
upon the density and arrangement of the adhesive, and the Examiner
provides no evidence that the adhesive has pores that are smaller in size than
the needles used by Prausnitz. “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).
Nor does the Examiner provide any reason to modify the adhesive
layer of Prausnitz to contain pores smaller than the needles that would be
enlarged by penetration of the needles. As Appellant notes, the mode of
operation of claim 1, where deformation of a reservoir layer enlarges pores
to increase drug delivery differs from the operation of Prausnitz where
deformation of a reservoir layer forces drug delivery through already present
microneedles (FF 9–12). The Examiner provides no persuasive reason to
modify Prausnitz to replace needles with pores.
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s conclusion that Prausnitz alone, or with Gardeniers renders the
claims obvious.
SUMMARY
We affirm the rejection of claims 1, 3, 5–10, 12–18, and 21 on the
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ground of nonstatutory double patenting as being unpatentable over claims
1–12 of U.S. Patent No. 8,758,311.
We affirm the rejection of claims 1, 3, 5–10, 12–18, and 21 under 35
U.S.C. § 112, first paragraph as failing to comply with the written
description requirement.
We reverse the rejection of claims 1, 3, 5–7, 9, 10, 12–18, and 21
under 35 U.S.C. § 103(a) as obvious over Prausnitz.
We reverse the rejection of claim 8 under 35 U.S.C. § 103(a) as
obvious over Prausnitz and Gardeniers.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED