Ex Parte Prokop

Board of Patent Appeals and Interferences

Sep 30, 2003

09169459 (B.P.A.I. Sep. 30, 2003)

1Claims 12, 14, 16-25, and 27-29 were cancelled after the Final Rejection (After-Final Amendment filed
December 19, 2001, Paper No. 17 was entered as per Advisory Action mailed January 18, 2002, Paper No. 18; see
also Answer, p. 2).
The opinion in support of the decision being entered today was not written for publication and
is not binding precedent of the Board.
Paper No. 24
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte ALES PROKOP
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Appeal No. 2003–0681
Application No. 09/169,459
____________
ON BRIEF
____________
Before WILLIAM F. SMITH, TIMM, and GRIMES, Administrative Patent Judges.
TIMM, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims 1-3, 6-11, 13, 15, and 30 which are all the claims pending in
the application.1 We have jurisdiction over the appeal pursuant to 35 U.S.C. § 134.
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INTRODUCTION
The claims are directed to a method of making nanoparticles comprised of a quaternary
polyanionic/cationic complex. Appellants define a nanoparticle as a “submicroscopic (less than
1 micrometer in size) solid object, essentially of regular or semi-regular shape.” (specification, p.
16, ll. 19-21). The complex is formed by contacting at least two polyanionic polymers with at
least two cations. Claim 1 is illustrative of the subject matter on appeal:
1. A method of making nanoparticles comprised of a polyanionic/cationic complex,
wherein said nanoparticles do not dissolve in physiological media for at least one day so as to be
useful in drug delivery, said method comprising the steps of:
contacting at least two polyanionic polymers with at least two cations, wherein said
contacting is by a process selected from the group consisting of capturing a mist of droplets
comprising said polyanionic polymers in a liquid comprising said cations; and, capturing a mist
of droplets comprising said cations in a liquid comprising said polyanionic polymers.
All of the pending claims stand rejected under 35 U.S.C. § 103(a). As evidence of
obviousness, the Examiner relies upon the following prior art references:
Andrianov et al. (Andrianov)5,529,777Jun. 25, 1996
Krone et al. (Krone) 5,700,459 Dec. 23, 1997
Wang et al. (Wang) 5,997,900 Dec. 7, 1999
( filed Apr. 16, 1997)
The specific rejection is as follows: Claims 1-3, 6-11, 13, 15, and 30 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Wang in view of Andrianov and Krone.
We reverse for the reasons that follow.
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Application No. 09/169,459
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OPINION
The examiner bears the initial burden of presenting a prima facie case of unpatentability.
In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). This burden must
be satisfied by the examiner, otherwise, without more, applicants are entitled to a patent. Id.
To satisfy the burden, the examiner must establish a factual basis to support the legal
conclusion of obviousness. See In re Fine, 837 F.2d 1071, 1073, 5 USPQ2d 1596, 1598 (Fed.
Cir. 1988). In so doing, the examiner must not only identify where in the references the
limitations of the claim are taught, the examiner must also identify what in the prior art supports
a finding of a reason, suggestion, or motivation to modify the prior art or to combine prior art
references to arrive at the claimed invention. See In re Huston, 308 F.3d 1267, 1280, 64
USPQ2d 1801, 1810 (Fed. Cir. 2002); In re Lee, 277 F.3d 1338, 1343, 61 USPQ2d 1430, 1433
(Fed. Cir. 2002). “The motivation, suggestion or teaching may come explicitly from statements
in the prior art, the knowledge of one of ordinary skill in the art, or, in some case the nature of the
problem to be solved.” In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir.
2000). But, importantly, the evidence must support the rationale of the examiner. Lee, 277 F.3d
at 1343, 61 USPQ2d at 1433.
The rejection is based on the conclusion that it would have been obvious to one of
ordinary skill in the art at the time of invention to modify the size of Wang’s microparticles
(Answer, p. 5). As found by the Examiner, Wang describes microencapsulation of antibodies
using the required quaternary complex (Answer, p. 3). The Examiner acknowledges that Wang
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does not describe forming nano-sized microparticles and turns to Krone for a teaching of
nanoparticles using a polyelectrolyte complex containing an active agent (Answer, p. 4).
Because Krone describes how to form nanoparticles for delivery of the active substance in vivo,
the Examiner concludes that one of ordinary skill in the art would have been motivated to modify
the size of the microparticles of Wang to improve the delivery profile of a bioactive agent of
choice (Answer, p. 5).
The problem is that Wang does not intend to use the encapsulated antibodies described
therein as active agents, rather, Wang uses the encapsulated antibodies in tests to assess capsule
permeability (Wang, col. 3, ll. 1-10 and Example 1). Through the permeability tests, Wang
identifies capsule complexes that protect cells encapsulated therein from immune attack while
allowing the influx of molecules important for cell function/survival and the efflux of desired
cellular products (Wang, col. 1, ll. 31-37, col. 3, ll. 1-10). The capsules of Wang are to be stable
for long periods of time to protect cells from immune attack (Wang, Example 14). Krone uses
polyelectrolyte complexes different than Wang to prepare micro/nanoparticles which carry active
agents. Release of the active agents occurs upon dissolution of polyelectrolyte complexes
(Krone, col. 2, ll. 26-29). While Krone expresses an interest in forming nanoparticles, the
polyelectrolyte system and properties required in the intended use are different. The fact finding
in the rejection falls short of establishing a link between the polyelectrolyte complexes of Wang
and a reason, suggestion, or motivation to form nanoparticles with those complexes.
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We conclude that the Examiner has failed to establish a prima facie case of obviousness
with regard to the subject matter of claims 1-3, 6-11, 13, 15, and 30.
CONCLUSION
To summarize, the decision of the Examiner to reject claims 1-3, 6-11, 13, 15, and 30
under 35 U.S.C. § 103(a) is reversed.
REVERSED
WILLIAM F. SMITH )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
CATHERINE TIMM ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
ERIC GRIMES )
Administrative Patent Judge )
CT/jrg
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