Ex Parte Chlon et al

Patent Trial and Appeal Board

Aug 2, 2016

13387503 (P.T.A.B. Aug. 2, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/387,503 01127/2012 Caecilia Chlon
24737 7590 08/04/2016
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus A venue
Suite 340
Valhalla, NY 10595
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
2009P01380WOUS 1833
EXAMINER
ROSENTHAL, ANDREWS
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
08/04/2016 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):
marianne.fox@philips.com
debbie.henn@philips.com
patti. demichele@Philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CAECILIA CHLON and
MARCEL BOHMER
Appeal2014-006260
Application 13/387,503
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREYN. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
for preparing biologically active agent filled polymer microparticles. The
Examiner rejected the claims as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as KONINKLIJKE PHILIPS
N.V. (see App. Br. 3).
Appeal2014-006260
Application 13/387,503
Statement of the Case
Background
"Microparticle based ultrasound contrast agents are in use to enhance
ultrasound contrast in medical imaging" (Spec. 1 :7-8). "Drug delivery can
also take place directly from drug loaded microbubbles themselves, which
would allow a drastic change in the biodistribution with the potential to
reduce side-effects of, for instance, cytotoxic agents" (Spec. 1: 11-13).
The Claims
Claims 1-11 are on appeal. Independent claim 1 is representative and
reads as follows:
1. A method for preparing biologically active agent filled
polymer microparticles, said method comprising the steps of:
a) providing a first emulsion (A) by mixing an organic
solvent (1 ), a biodegradable polyester, and an organic non-
solvent for the polymer (2), wherein the ratio of biodegradable
polyester/organic non-solvent (2) is 1:10 to 1:1 % w/w, and
adding to this mixture up to 40% v/v of an aqueous solution and
wherein a biologically active agent is added to the organic
mixture and or aqueous solution;
b) preparing a second emulsion (B) by adding to this first
emulsion (A) excess of an aqueous solution;
c) applying conditions for volatizing the organic solvent
(1);
d) applying conditions for removal of water; and
e) applying conditions for removal of the non-solvent (2),
wherein steps d) and e) are performed separately.
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Application 13/387,503
The Issues2
The Examiner rejected claims 1-11 under 35 U.S.C. § 103(a) as
obvious over Bohmer3 and Ottoboni4 (Ans. 2---6).
The Examiner finds it obvious "to prepare microparticles according to
an emulsification technique as recited in instant claims 1-11 because
Bohmer discloses this process for the preparation of a drug-delivery
microparticle" (Ans. 5). The Examiner finds that "[a]lthough Bohmer
teaches adding the organic phase to the aqueous phase in preparing the first
emulsion ... it would have been obvious to a person of ordinary skill in the
art to rearrange the order of method steps and add the aqueous phase to the
organic phase" (Ans. 5).
The Examiner further finds that "Ottoboni teaches using a hydrophilic
polymer (specifically amphiphilic) as opposed to the generally hydrophobic
ones of Bohmer. Therefore, the skilled artisan would know that the
hydrophilicity of the polymer shell can be varied in the inventions of
Bohmer and Ottoboni" (Ans. 6).
Appellants contend that Bohmer "relate[ s] to combining a mixture
with an aqueous composition to form an emulsion. However, it is
respectfully asserted that the cited portions of Bohmer do not teach or
suggest at least, 'providing a first emulsion (A)' and 'preparing a second
emulsion (B)' [as] in claim l" (App. Br. 10).
2 The double patenting rejection over copending U.S. Application
12/161,703 is moot in view of the abandonment of that application.
3 Bohmer et al., WO 2007 /085990 Al, published Aug. 2, 2007 ("Bohmer").
4 Ottoboni et al., US 2009/0081130 Al, published Mar. 26, 2009
("Ottoboni").
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Appeal2014-006260
Application 13/387,503
The issue with respect to this rejection is: Does the evidence of record
support the Examiner's conclusion that Bohmer and Ottoboni render claim 1
obvious?
Findings of Fact
1. Bohmer teaches:
a method for the production of particles comprising a gas
core and a shell which method comprises the steps of:
a) providing a mixture comprising a shell composition, a
first solvent (1) and a second non-solvent (2);
b) combining the mixture of step (a) with an aqueous
composition thereby forming an emulsion of the mixture of step
(a) in an aqueous phase;
c) applying conditions for volatizing solvent (1)
d) applying conditions for removal of water
e) applying conditions for removing of non-solvent (2)[.]
(Bohmer 3).
2. Bohmer teaches that "[p ]referably the shell composition
containing mixture of step (a) is added to an aqueous composition. To
create an emulsion, preferably stirring or another form of agitation/shear
forces is applied" (Bohmer 5).
3. Bohmer then teaches that "[o]ptionally further emulsification
treatment is included to form an emulsion with the desired, preferably
monodispersed, particle size distribution" (Bohmer 5).
4. Bohmer teaches, in Example 1, that
Pla-pfo [(poly-(lactic acid) with a perfluorinated moiety)] was
dissolved in dichloromethane to obtain a 5% (w/w) solution
(solution A). Cyclodecane was mixed with dichloromethane to
obtain a 10% (w/w) mixture (solution B). A quantity of 0.25 g of
solution A was mixed with 1 g of solution B. ([S]tep a)[.] This
mixture was added to lOg of 0.3% pva solution [(polyvinyl
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Application 13/387,503
alcohol)] and emulsified by pressing the mixture through a glass
filter.
(Bohmer 12).
5. Bohmer teaches that the emulsion process of Example 1 "was
repeated 10 times (step b) after which the emulsion was stirred for one hour
to evaporate the dichloromethane and complete capsule formation (step c )"
(Bohmer 12).
6. Bohmer teaches that a "quantity of 0.25 g of solution A and
0.25 g of solution B was mixed with 1 g of solution B (step a). This mixture
was added to lOg of 0.3% pva solution" (Bohmer 13).
7. Bohmer teaches that "0.5 g of polymer solution, 1 g of the
paclitaxel solution, 100 mg of hexadecane and 100 mg of cylodecane and
0.5 g of dichloromethane were mixed. This mixture was added to 1 Og of
0.3% pva solution and emulsified .... " (Bohmer 15).
8. Ottoboni teaches "about three parts of the organic polymer
solution having a concentration of about 0.5 to 10 percent of the polymer is
added to one part of the aqueous biomaterial solution" (Ottoboni i-f 21).
Principles of Law
"Normally, it is to be expected that a change ... in concentration ...
would be an unpatentable modification .... More particularly, where the
general conditions of a claim are disclosed in the prior art, it is not inventive
to discover the optimum or workable ranges by routine experimentation." In
re Aller, 220 F.2d 454, 456 (CCPA 1955).
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Application 13/387,503
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2-6; FF 1-8) and agree that the
claims are rendered obvious by Bohmer and Ottoboni. We address
Appellants' arguments below.
We recognize, but find unpersuasive, Appellants' contention that
"Bohmer do not teach or suggest at least, 'providing a first emulsion (A)'
and 'preparing a second emulsion (B)' [as] in claim 1" (App. Br. 10).
Bohmer specifically teaches after forming an emulsion (FF 2) that
"[ o ]ptionally further emulsification treatment is included to form an
emulsion with the desired, preferably monodispersed, particle size
distribution" (FF 3). Moreover, Bohmer in Example 1 teaches that the
emulsion process "was repeated 10 times (step b)" (FF 5).
Appellants contend that "there is no teaching or suggestion in the
cited portions of Bohmer of 'adding to this mixture up to 40% v/v of an
aqueous solution,' as in claim 1" (App. Br. 11 ). Appellants contend that
the Bohmer teaching of adding 10 g of an aqueous solution to the
1.25 g mixture far exceeds the range of "up to 40% v/v of an
aqueous solution" as recited in claim 1. The Examiner states that
the range taught by Bohmer "can be treated as a starting point for
the skilled artisan to optimize". However, a person with ordinary
skill in the art would have no suggestion to add up to 40% v/v of
an aqueous solution when viewing the teachings of Bohmer.
(Reply Br. 8).
We are not persuaded. While Example 1 of Bohmer mixes 10 g of the
pva aqueous solution with 1.25 g of mixture (FF 4), Example 2 adds 1.5 g of
mixture (FF 6), and Example 5 adds 2.2 g of mixture (FF 7), demonstrating
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Application 13/387,503
that the relative amounts of mixture to pva aqueous solution is a result
effective variable. "[D]iscovery of an optimum value of a result effective
variable in a known process is ordinarily within the skill of the art." In re
Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence
of any secondary consideration such as unexpected results that would render
the optimized amounts of aqueous solution nonobvious.
Appellants contend that "[a]s would be understood by one of ordinary
skill in the art, the cited portions of Ottoboni provide a single emulsion of
oil/water. Thus, the cited portions of Ottoboni fail to cure the deficiencies of
Bohmer" (App. Br. 12).
We are not persuaded. The Examiner relies upon Ottoboni for an
amphiphilic polymer (see Ans. 11) and as evidence that microparticle
emulsions may be formed between organic polymer solutions and aqueous
solutions with three parts organic to one part aqueous or 25% v/v of an
aqueous solution (FF 8; cf Ans. 10 (citing Ottoboni i-f 21)). As here, the
"combination of familiar elements according to known methods is likely to
be obvious when it does no more than yield predictable results." KSR Int'!
Co. v. Teleflex, Inc., 550 U.S. 398, 416 (2007).
Appellants contend that "Ottoboni teaches that the organic polymer
solution is added to the aqueous solution not that the aqueous solution is
added to the mixture of the remaining components" (Reply Br. 6).
Appellants contend that the Ottoboni "process is totally different from the
method recited in claim 1 wherein an organic solvent, a biodegradable
polyester, and an organic non-solvent for the polymer are all first mixed
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together and 40% v/v of an aqueous solution is added in order to prepare a
first emulsion" (Reply Br. 7).
We find this argument unpersuasive because Bohmer teaches and
exemplifies the order of addition and a process very similar to that required
by claim 1 (FF 1--4), and Ottoboni is relied upon to suggest other elements
of the claims. "The test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the structure of the
primary reference . . . Rather, the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art." In re
Keller, 642 F.2d 413, 425 (CCPA 1981).
Conclusions of Law
The evidence of record supports the Examiner's conclusion that
Bohmer and Ottoboni render claim 1 obvious.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Bohmer and Ottoboni. Claims 2-11 fall with claim
1.
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
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