Ex Parte Akiyama et al

Patent Trial and Appeal Board

Dec 18, 2012

11508732 (P.T.A.B. Dec. 18, 2012)

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.
11/508,732 08/22/2006 Hidero Akiyama 912162.447 2703
500 7590 12/19/2012
SEED INTELLECTUAL PROPERTY LAW GROUP PLLC
701 FIFTH AVE
SUITE 5400
SEATTLE, WA 98104
EXAMINER
PATEL, SHEFALI DILIP
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
12/19/2012 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
__________

Ex parte HIDERO AKIYAMA, MIZUO NAKAYAMA,
TAKEHIKO MATSUMURA, and AKIHIKO MATSUMURA
__________

Appeal 2010-012154
Application 11/508,732
Technology Center 3700
__________

Before FRANCISCO C. PRATS, MELANIE L. McCOLLUM, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
iontophoresis device. The Examiner has rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We reverse.

STATEMENT OF THE CASE
Claims 1-36 are pending and on appeal (App. Br. 1-2). We will focus
on claims 1, 3, and 21, the only independent claims on appeal, which are set
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forth in the Claims Appendix to the Appeal Brief (id. at 43-50). Claim 1 is
illustrative and reads as follows:
1. An iontophoresis device used for administering an ionic active
agent by iontophoresis comprising:
an active electrode assembly comprising:
an active electrode;
an electrolyte solution reservoir that holds an electrolyte
solution, the electrolyte solution reservoir placed on an outer surface of the
active electrode;
a second ion exchange membrane that selectively passes ions
having a polarity opposite that of the ionic active agent, the second ion
exchange membrane placed on an outer surface of the electrolyte solution
reservoir;
an active agent reservoir that holds the ionic active agent, the
active agent reservoir placed on an outer surface of the second ion exchange
membrane; and
a first ion exchange membrane that selectively passes ions
having the same polarity as the ionic active agent, the first ion exchange
membrane placed on an outer surface of the active agent reservoir,
a counter electrode assembly comprising a counter electrode;
a DC electric power source connected to the active electrode of the
active electrode assembly and to the counter electrode of the counter
electrode assembly; and
a liquefying device selectively operable to excite at least one of the
electrolyte solution reservoir and the active agent reservoir,
wherein at least one of the electrolyte solution reservoir and the active
agent reservoir consists of a gel matrix that transforms to a liquid upon
excitation by the liquefying device.
Claims 1-4, 6, 8-13, 15, 17-24, 28, 30, 31, 33, 34, and 36 stand
rejected under 35 U.S.C. § 103(a) as obvious over Haak et al. (US
5,647,844, Jul. 15, 1997) in view of Gould et al. (US 5,000,955, Mar. 19,
1991) (Ans. 4).
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Claims 5, 7, 14, 16, 26, 29, 32, and 35 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Haak in view of Gould and Tengler et al. (US
2006/0193877 A1, Aug. 31, 2006) (Ans. 14).
Claim 25 stands rejected under 35 U.S.C. § 103(a) as obvious over
Haak in view of Gould and Zhang et al. (US 2003/0093057 A1, May 15,
2003) (Ans. 17).
Claim 27 stands rejected under 35 U.S.C. § 103(a) as obvious over
Haak in view of Gould and Lipkovker (US 5,421,816, Jun. 6, 1995)
(Ans. 17).

I
The Examiner relies on Haak for teaching “an iontophoresis device
(Figure 2, device [20]) comprising . . . an active electrode assembly (donor
electrode assembly [8])” and “a counter electrode assembly (counter
electrode assembly [29])” substantially as claimed (Ans. 4-5). However, the
Examiner finds that Haak “does not teach that the gel matrix transforms into
a liquid upon excitation by a liquefying device that is selectively operable to
excite at least one of the electrolyte solution reservoir [13] and the active
agent reservoir [15]” (id. at 5).
The Examiner relies on Gould for teaching “a gel matrix, which is
suitable for medical uses, and which liquefies upon thermal excitation by a
liquefying device („diathermy machine‟), in order to release an entrapped
drug within the gel matrix” (id.). The Examiner concludes that it would
have been obvious “to implement a liquefying device that transforms a gel
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matrix into a liquid, as taught by Gould et al, with the iontophoresis device,
of Haak” (id.).

Analysis
Appellants argue that the Examiner has not provided an adequate
rationale to combine Haak and Gould (App. Br. 19). We agree.
The Examiner concludes that it would have been obvious
to implement a liquefying device that transforms a gel matrix
into a liquid, as taught by Gould et al, with the iontophoresis
device, of Haak et al, as the liquefying device will raise the
temperature of the gel matrix, such that the gel matrix releases
an entrapped drug to the patient‟s body.
(Ans. 5.) In support of this position, the Examiner finds that an “unexpected
and beneficial result is that the combined action of the drug and the heat
developed by the liquefying device will exert a synergistic effect, thereby
enhancing the therapy” (id.). (See also Ans. 7-8 & 11-12, which relate to the
rejections of claims 3 and 21.)
However, the synergistic effect described in Gould is a synergistic
therapeutic effect between the drug and the heat on a tumor (Gould, col. 5,
ll. 31-44), not a synergistic effect impacting the release of the drug per se.
We agree with Appellants that the Examiner has not adequately explained
how this synergistic effect is applicable to Haak‟s transdermal delivery of
drugs (App. Br. 18). Thus, given that Haak discloses an active means of
drug delivery, that is, iontophoresis, we conclude that the Examiner has not
adequately explained why it would have been obvious to raise the
temperature of the gel matrix to release the drug.
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Appellants also argue that the Examiner has not shown that Haak
teaches that the “permeability of layer 17 to ions is in any way selective,
much less selective on the basis of charge or polarity” (id. at 20). We agree.
Claim 1 recites an ion exchange membrane, placed on an outer surface
of the active agent reservoir, “that selectively passes ions having the same
polarity as the ionic active agent.” The Examiner finds that Haak‟s ion-
conducting layer 17 is such an ion exchange membrane (Ans. 5). However,
we agree with Appellants that the Examiner has not set forth a prima facie
case that Haak‟s ion-conducting layer 17 “selectively” passes ions. As noted
by the Examiner (id. at 20), the Specification defines the term “ion exchange
membrane” as “a membrane that substantially passes and/or substantially
blocks ions based primarily on the polarity or charge carried by the ion”
(Spec. 6: 1-5 (emphasis added)). However, the fact that the membrane may
pass or block ions based on factors other than polarity or charge does not
negate the requirement that the membrane passes or blocks ions based on
polarity or charge, particularly in view of the recitation in claim 1 that the
ion exchange membrane is selective. The Examiner has not shown where or
how the disclosure in Haak meets this requirement.

Conclusion
The Examiner has not set forth a prima facie case that it would have
been obvious to combine Haak with Gould. Thus, we conclude that the
Examiner has not set forth a prima facie case of obviousness with regard to
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claim 1, as well as claims 3
1
and 21, which are also rejected over this
combination (Ans. 7-8 & 11-12).
In addition, the Examiner has not set forth a prima facie case that
Haak and/or Gould teach or suggest an ion exchange membrane, placed on
an outer surface of the active agent reservoir, that selectively passes ions
having the same polarity as the ionic active agent. Thus, with regard to
claim 1 (but not claims 3 and 21, which do not recite this feature), we
conclude that the Examiner has not set forth a prima facie case of
obviousness for this additional reason.
For the forgoing reason(s), we reverse the obviousness rejection of
claims 1, 3, and 21 and of claims 2, 4, 6, 8-13, 15, 17-20, 22-24, 28, 30, 31,
33, 34, and 36, which depend from claims 1, 3, or 21.

1
In rejecting claim 3, the Examiner finds that Haak “does not teach that the
gel matrix transforms into a liquid upon excitation” (Ans. 8). Instead, the
Examiner relies on Gould to teach this feature (id.). However, as discussed
above, the Examiner has not set forth a prima facie case that it would have
been obvious to combine Haak with Gould. That being said, claim 3 does
not require a liquefying device. In addition, as noted by the Examiner, Haak
discloses that the matrix of reservoirs 13 and 15, which the Examiner relies
on for being the electrolyte solution and active agent reservoirs, respectively
(Ans. 7), can “be formed of a hydrophilic polymer which is swellable or
soluble in water, e.g., hydrogels,” and lists “[e]xamples of suitable
hydrophilic polymers” (Haak, col. 15, ll. 42-52). On remand, the Examiner
should consider whether Haak teaches or suggests a gel matrix that would
inherently have the ability to transform to a liquid upon excitation,
regardless of whether it would have been obvious to liquefy it.
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II
With regard to claims 5, 7, 14, 16, 25-27, 29, 32, and 35, the
Examiner relies on Haak and Gould as discussed above (Ans. 14 & 17-18).
In addition, the Examiner relies on Tengler, Zhang, or Lipkovker for
teaching various features of these dependent claims (id.). However, the
Examiner does not adequately explain how Tengler, Zhang, or Lipkovker
make up for the deficiencies in Haak and Gould discussed above. Therefore,
we also reverse the obviousness rejections of claims 5, 7, 14, 16, 25-27, 29,
32, and 35.

REVERSED

cdc